EMERGING MARKET ➢ Introduction : PPT/PDF

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EMERGING MARKET

➢ Introduction :

An emerging market (or an emerging country or an emerging economy) is a market that
has some characteristics of a developed market, but does not fully meet its
standards. This includes markets that may become developed markets in the future or were
in the past.

Emerging markets are the markets of developing countries that are rapidly growing
and industrializing. Emerging markets are the markets of developing countries that are
rapidly growing and industrializing.

An emerging market economy is an economy that’s transitioning into a developed
economy. Emerging market economies typically feature a unified currency, stock market,
and banking system; they’re in the process of industrializing. Emerging market economies
can offer greater returns to investors due to their rapid growth.

Emerging markets share the economic characteristics such as low income, high growth
economies that use market liberalization as their main means of growth. Of course, emerging
economies can develop out of such emerging status, entering the post-emerging stage. When
emerging markets “graduate” from their economic status, they are referred to as emerged
markets.[7] Countries like Israel, Poland, South Korea, Taiwan, the Czech Republic, and city-
states such as Singapore have transitioned from emerging to “emerged”.[7] These emerged
markets tend to be characterized by higher incomes and relatively stable political schemes,
compared to those categorized as emerging markets.

➢ KEY TAKEAWAYS

• An emerging market economy is an economy that is in the process of becoming a
developed economy.

• Emerging market economies typically feature a unified currency, stock market, and
backing system, and are in the process of industrializing.

• Emerging market economies can offer greater returns to investors due to rapid
growth, but also offer greater exposure to some inherent risks due to their status.

 

 

➢ COUNTRIES COVERED EMERGING MARKET :

 

The Five Major Emerging Markets. Brazil, Russia, India, China, and South Africa are the
biggest emerging markets in the world.

 

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There are many emerging markets around the world, but the four largest are known as the
“BRICs” (an acronym for Brazil, Russia, India, and China). Many investors believe that these
markets are relatively stable and may eventually replace the G7 as the world’s next superpowers

Currently, the US is the world’s biggest market with a value of $47.32 trillion followed by
China ($11.52 trillion), Japan ($6 trillion) and Hong Kong ($5.55 trillion)

An emerging country is one whose economy is not yet fully developed yet either was in the
recent past or very likely will be in the near future. Emerging countries are also known as
emerging economies because the emphasis is on their economic development. There are
some emerging countries that you have probably heard of and some that may be less
familiar. Nevertheless, pay attention to these countries – you probably buy food that was
grown there or wear clothes that were made there. You will probably hear more about these
countries soon.

There are several different indices by which a country is measured as being emerging. The
most recognized of these indices is the International Monetary Fund, which monitors
economic development around the world and provides monetary assistance to developing
countries.

Some of the most rapidly emerging countries include Brazil, Turkey, Russia, India,
and China. Other emerging countries include the oil-rich countries of Bahrain, Saudi
Arabia, Iran, Kuwait, the United Arab Emirates, Qatar, Oman, and Iraq. Many of these
countries are immensely wealthy because of their oil exports, yet that wealth does not come
from a well-developed private sector and job growth. Because these countries depend
almost exclusively on a single resource – oil – for their growth, a collapse in oil prices could
set their economics back decades.

Other emerging countries are found in Eastern Europe, in the former Soviet Union
– Latvia, Romania, Bulgaria, the Czech Republic, Hungary, Slovenia, and Slovakia. Because
of their experiences under communism, they are less developed than countries in Western
Europe and are still developing their economies to catch up. However, the European
Union aims to increase equity across European countries, particularly those that were part of
the Soviet Union, to help improve the economic outlook and quality of life for the past Soviet
countries. Kazakhstan is a former Soviet country that is located in Central Asia rather
than Europe, and it is also an emerging country.

There are many emerging countries in other parts of the world, including Africa (countries
such as Algeria, Tunisia, Morocco, and South Africa), South Asia (Indonesia, Sri
Lanka, Bangladesh), South America (Argentina, Chile, Colombia), and the South Pacific.

Many emerging countries have poor records of human rights, and critics claim that their
governments are placing economic growth ahead of the well-being of its citizens. The
governments of several emerging countries are known to engage in systemic human rights
violations.

 

 

 

➢ STUDY OF WORLD MAP: Characteristics of Emerging Markets

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Some common characteristics of emerging markets are illustrated
below:

1. Market volatility

Market volatility stems from political instability, external price
movements, and/or supply-demand shocks due to natural calamities. It
exposes investors to the risk of fluctuations in exchange rates, as well
as market performance.

2. Growth and investment potential

Emerging markets are often attractive to foreign investors due to the
high return on investment they can provide. In the transition from
being an agriculture-based economy to a developed economy,
countries often require a large influx of capital from foreign sources
due to a shortage of domestic capital.

Using their competitive advantage, such countries focus on exporting
low-cost goods to richer nations, which boosts GDP growth, stock
prices, and returns for investors.

3. High rates of economic growth

Governments of emerging markets tend to implement policies that
favor industrialization and rapid economic growth. Such policies lead to
lower unemployment, higher disposable income per capita, higher
investments, and better infrastructure. On the other hand, developed
countries, such as the USA, Germany, and Japan, experience low rates
of economic growth due to early industrialization.

4. Income per capita

Emerging markets usually achieve a low-middle income per capita
relative to other countries, due to their dependence on agricultural
activities. As the economy pursues industrialization and manufacturing
activities, income per capita increases with GDP. Lower average
incomes also function as incentives for higher economic growth.

The Five Major Emerging Markets

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Brazil, Russia, India, China, and South Africa are the biggest emerging
markets in the world. In 2009, the leaders of Brazil, Russia, India, and
China formed a summit to create “BRIC,” an association created in
order to improve political relationships and trade between the largest
emerging markets. South Africa joined the “BRIC” group in 2010, which
was then re-named “BRICS.”

 

 

 

1. Brazil

Brazil’s economy on a relative basis grew rapidly during the early 2010s at
a rate of 7.5%. Due to political instability and trade sanctions, however, the
growth rate slowed down and became negative in 2016 (-3.5%). Brazil also
experienced considerable improvements in income levels and poverty
reduction in 2003-2014, but changes have been sluggish since 2015 due to
lower economic activity.

The Brazilian economy has been affected largely by political uncertainties
and lower government expenditure. However, the outlook for the country’s
future is positive. The domestic economy grew 0.6% in 2019 and is
expected to sustain the growth through infrastructure improvements
and foreign investments, along with its reliance on agricultural
commodities like soybean and coffee.

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2. Russia

Driven primarily by oil exports and a rise in oil prices, Russia experienced
exponential growth in its GDP during the period 1999-2008 (before the
Global Financial Crisis). The transition from communism to capitalism that
has been taking place since 1991 has boosted economic growth in the
country through economic reforms and an export-oriented trade policy.

However, since 2014, Russia’s economy has been negatively affected by
political conflicts and trade sanctions that have been imposed by the US,
Canada, Japan, and the EU, along with fluctuations in the price of oil, which
accounts for close to 52% of Russian exports. The Russian economy grew
at a rate of 1.7% in 2019 and is expected to grow faster if geopolitical
tensions with trade partners like the US, Canada, Japan, and the EU
reduce.

 

3. India

India established itself as an emerging market after trade liberalization and
other major economic reforms in 1991. The Indian economy has been
growing steadily at relatively high rates. It averaged 7.1% in the past
decade, with some fluctuations due to political instability and economic
reforms.

Essentially, India’s long-term economic growth can be attributed to the
expansion of the manufacturing and service sectors, driven by exports and
foreign investment. India is also experiencing gains both in capital and
labor productivity due to technological advancements and educational
reforms. As of now, India is one of the largest emerging markets, along with
China.

 

4. China

The Chinese economy has posted an average growth rate of 10% since the
enactment of trade liberalization and economic reforms in 1978. China’s
economic growth has been propelled by government spending, expansion
of its manufacturing sector, and exports (specifically electronic equipment).

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However, the country’s income per capita is still low. Although only 3.3% of
the Chinese population lives below the poverty line, 30% of the population
lives below US$5.50/day. Nonetheless, as the Chinese government
focuses on increasing GDP through consumption, disposable incomes are
likely to increase, leading to sustained economic growth.

 

5. South Africa

South Africa was inducted into the BRICS association in 2010, after
experiencing negative GDP growth in 2009 following the 2008 Global
Financial Crisis (-3%). Following the financial crisis, the South African
government implemented a number of policies to boost GDP through
government expenditure and consumption. Economic growth increased in
2010-12 before slowing down in 2012-16 and rising again in 2017.

South African exports are composed primarily of commodities from mining.
Therefore, export volumes depend on the prices of commodities, which are
highly volatile. Fluctuations in export volumes explain part of the variation in
GDP growth over the last few years.

Although South African GDP per capita has been increasing over time, so
has the unemployment rate (29% as of 2019). High levels of unemployment
and crime have hindered the economy’s growth and investment potential,
and are issues that need to be addressed through policy reforms.

 

 

 

 

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Emerging markets are countries that have some characteristics of a developed
market but are not yet a fully developed market. A key difference between emerging
markets and emerging economies is that emerging markets are not fully described
by, or constrained to, geography or economic strength whereas emerging economies
are constrained by political and geographic boundaries. These countries are
experiencing rapid growth and industrialization and are attractive due to higher risk
and return premium over already developed countries.

 

 

VARIOUS COMMITIES ACROSS THE GLOBE :-

 

• ASEAN -Association of Southeast Asian Nations
• APEC – Asia-Pacific Economic Cooperation
• EAC – Economic Advisory Council
• GCC – Gulf Cooperation Council
• PANDRH – Pan American Network for Drug Regulatory Harmonization
• SADC – Southern African Development Community

 

o ASEAN

ASEAN – The Association of Southeast Asian Nations, or ASEAN, was established on 8
August 1967 in Bangkok, Thailand, with the signing of the ASEAN Declaration

ASEAN brings together ten Southeast Asian states – Brunei, Cambodia, Indonesia, Laos,
Malaysia, Myanmar, the Philippines, Singapore, Thailand and Vietnam – into one
organisation

 

Purpose : The ASEAN Declaration states that the aims and purposes of the Association are:
(1) to accelerate economic growth, social progress and cultural development in the
region

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(2) to promote regional peace and stability through abiding respect for justice and the rule of
law in the relationship among countries region and (2) to promote regional peace and
stability through abiding respect for justice and the rule of law in the relationship among
countries

HEAD OF ASIAN :- Secretary-General of the Association of Southeast
Asian Nations

1. officially the Association of Southeast Asian Nations, is a political and economic union
of 10 member states in Southeast Asia, which promotes intergovernmental
cooperation and facilitates economic, political, security, military, educational,
and sociocultural integration between its members and other countries in Asia.

2. ASEAN’s primary objective was to accelerate economic growth and through that social
progress and cultural development

3. A secondary objective was to promote regional peace and stability based on the rule of
law and the principle of United Nations

4. With some of the fastest growing economies in the world, ASEAN has broadened its
objective beyond the economic and social spheres

5. When institutional investors think about Asia’s emerging markets, they may
tend to pay more attention to the larger and more industrialized economies
such as China, Korea and Taiwan. Proportionally less attention is likely paid
to the smaller Southeast Asian nations such as Singapore, Indonesia and
Malaysia. Yet these countries, which together with Thailand and the
Philippines constitute the MSCI AC ASEAN Index, have returned 5.6% a year
(gross) over the 10-year period ending Dec. 31, 2016.

6. Examining returns by dividend yield, dividend growth (which essentially
reflects fundamental growth in cash flows) and changes in valuation illustrates
the case. Our research suggests that the first two components historically were
the two most important contributors to global equity performance in both
emerging and developed markets over the long term (below chart). While
valuation changes tended to dominate market performance over the short
term, dividend yield and growth in cash flows were critical return drivers over
the longer term.

7. A comparison of the ASEAN Index with broader emerging markets indexes
generally highlights the fundamental growth of the former. Dividend yield and
dividend growth together accounted for 91% of total returns in ASEAN over
the 10-year period ending Dec. 31. In particular, dividend growth for the
ASEAN Index exceeded that of the MSCI Emerging Markets Asia Index
(which includes China, Taiwan and Korea) as well as the broader MSCI
Emerging Markets Index.

8. These growth characteristics reflect ASEAN countries, which together
comprise the third-largest population globally. More than half of the population
is under 30. Meanwhile, nearly half the population lives in urban
areas,1 compared to Japan and the U.S., where 93.5% and 82.4%,
respectively, live in urban areas. A lower percentage suggests there is greater
potential for growth.

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9. With the exception of companies in Singapore, those in ASEAN countries
derived more than three-quarters (77%) of their revenues domestically,
according to MSCI’s economic exposure data. Trade within the bloc
accounted for 11% of international economic exposures, as of Oct. 31, 2016.
In contrast, companies from more industrialized Asian economies such as
Korea and Taiwan derived less than half their revenue domestically. The
domestic nature of ASEAN companies’ economic exposure may insulate
those firms from an increase in protectionist sentiment worldwide.

 

 

 

 

 

APEC

 

 

A brief history of APEC

• In 1989, it was founded. It has its headquarters in Singapore and the
Secretariat of APEC is located in Singapore.

• It shall be headed by a fixed-term Executive Director who shall be selected for
a three-year term. It develops and offers technical & advisory support and
information management, communications & public outreach programs.

 

• The Asia-Pacific Economic Cooperation ( APEC; / eɪpɛk / AY-pek) is an inter-
governmental forum for 21 member economies in the Pacific Rim that
promotes free trade throughout the Asia-Pacific region.

• APEC or the Asia-Pacific Economic Cooperation was established in 1989 as a
regional economic forum to promote sustainable growth and better economic
relations among the member countries or economies. APEC – 12 founding
members established APEC in 1989.

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• The countries that are members of APEC are Canada, Brunei Darussalam,
Australia, Chile, Hong Kong, Indonesia, China, Japan, Malaysia, New
Zealand, Republic of South Korea, Mexico, Peru, Papua New Guinea, Russia,
The Republic of the Philippines, Vietnam, Singapore, Thailand, Chinese
Taiwan and the United States of America.

• APEC ensures that goods, services, investment and people move easily across
borders. Members facilitate this trade through faster customs procedures at borders;
more favorable business climates behind the border; and aligning regulations and
standards across the region. For example, APEC’s initiatives to synchronize
regulatory systems is a key step to integrating the Asia-Pacific economy. A product
can be more easily exported with just one set of common standards across all
economies.

• APEC works to help all residents of the Asia-Pacific participate in the growing
economy. For example, APEC projects provide digital skills training for rural
communities and help indigenous women export their products abroad. Recognizing
the impacts of climate change, APEC members also implement initiatives to increase
energy efficiency and promote sustainable management of forest and marine
resources

Main objectives of the APEC

• It guarantees that goods, services, investments and people are easily moved
across territories.

• It ensures smoother border customs procedures.

• It guarantees a favourable business environment behind bars.

• The norms and practices around the border are coordinated.

• It seeks to strengthen the diplomatic and economic understanding of member
nations

 

 

 

 

 

 

 

 

 

 

 

 

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EAC

 

East African Community (EAC) is an intergovernmental organisation
comprising the five east African countries: Burundi, Kenya, Rwanda, Tanzania,
and Uganda. It is headquartered in Arusha, Tanzania.

• The East African Community (EAC) is a regional intergovernmental
organisation of 7 Partner States: The Democratic Republic of the Congo, the
Republics of Burundi, Kenya, Rwanda, South Sudan, Uganda, and the United
Republic of Tanzania, with its headquarters in Arusha, Tanzania.

1) The EAC is home to an estimated 300 million citizens, of which over 22% is
urban population. With a land area of 4.8 million square kilometres and a
combined Gross Domestic Product of US$ 240 billion (EAC Statistics for 2019),
its realisation bears great strategic and geopolitical significance and prospects
for the renewed and reinvigorated EAC.

2) The work of the EAC is guided by its Treaty which established the Community.
It was signed on 30 November 1999 and entered into force on 7 July 2000
following its ratification by the original three Partner States – Kenya, Tanzania
and Uganda.

3) The Republic of Rwanda and the Republic of Burundi acceded to the EAC
Treaty on 18 June 2007 and became full Members of the Community with effect
from 1 July 2007, while the Republic of South Sudan acceded to the Treaty on
15 April 2016 and become a full Member on 15 August 2016. The Community’s
newest member, the Democratic Republic of the Congo acceded to the EAC
Treaty on 8 April, 2022.

4) As one of the fastest growing regional economic blocs in the world, the EAC is
widening and deepening co-operation among the Partner States in various key
spheres for their mutual benefit. These spheres include political, economic and
social.

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5) At the moment, the regional integration process is in full swing as reflected by
the encouraging progress of the East African Customs Union, the establishment
of the Common Market in 2010 and the implementation of the East African
Monetary Union Protocol.

6) To accelerate economic growth and development, it means that the EAC Partner States
maintain a liberal stance towards the four Freedoms of movement for all the factors of
production and two Rights between themselves. These Freedoms and Rights include:

• Free Movement of Goods

• Free Movement of Persons

• Free Movement of Labour / Workers

• Right of Establishment

• Right of Residence

• Free Movement of Services

• Free Movement of Capital

Underlying the EAC Common Market are operational principles of the Community, namely:

• Non-discrimination of nationals of other Partner States on grounds of nationality;

• Equal treatment to nationals of other Partner States;

• Ensure transparency in matters concerning the other Partner States; and

• Share information for the smooth implementation of the Protocol.

The East African Community (EAC) is the regional intergovernmental organisation of the Republics of
Kenya, Uganda, the United Republic of Tanzania, Republic of Rwanda and Republic of Burundi with
its headquarters in Arusha, Tanzania. The Treaty for Establishment of the East African Community
was signed on 30 November 1999 and entered into force on 7 July 2000 following its ratification by
the original three Partner States – Kenya, Uganda and Tanzania. The Republic of Rwanda and the
Republic of Burundi acceded to the EAC Treaty on 18 June 2007 and became full Members of the
Community with effect from 1 July 2007.

The EAC was established with a vision to set up a prosperous, competitive, secure, stable and
politically united East Africa; and provide platform to widen and deepen Economic, Political, Social
and Culture integration in order to improve the quality of life of the people of East Africa through
increased competitiveness, value added production, trade and investments.

Aims and Objectives

The EAC aims at widening and deepening co-operation among the Partner States in, among others,
political, economic and social fields for their mutual benefit. To this extent the EAC countries
established a Customs Union in January 2005 and established a Common Market in July 2010,
subsequently a Monetary Union by 2012 and ultimately a Political Federation of the East African
States.

 

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GCC

• Cooperation Council for the Arab States of the Gulf, formerly known as the
Gulf Cooperation Council (GCC), is a political and economic alliance of six
Middle Eastern countries consisting of Saudi Arabia, Kuwait, the United Arab
Emirates, Qatar, Bahrain, and Oman.

• It aims to boost co-ordination, integration, and interconnection among
member countries in all fields in order to achieve unity among them.

• GCC is an economic and political union of 6 countries in the Arabian
Peninsula: Oman, Bahrain, Qatar, Kuwait, United Arab Emirates and Saudi
Arabia. It was established in 1981 in Riyadh, Saudi Arabia. The motivation
behind the GCC is to accomplish solidarity among its individuals dependent
on their regular targets and their comparative political and social characters,
which are established in Arab and Islamic societies

• This area has some of the fastest-growing economies in the world, mostly due to a boom
in oil and natural gas revenues coupled with a building and investment boom backed by
decades of saved petroleum revenues. In an effort to build a tax base and economic
foundation before the reserves run out, the UAE’s investment arms, including Abu Dhabi
Investment Authority, retain over US$900 billion in assets. Other regional funds also have
several hundreds of billions of dollars of assets under management

✓ PANDRH
• Pan American Network for Drug Regulatory Harmonization

(PANDRH): Technical Working Groups: Bioequivalence Working
Group. Framework for Implementation of Equivalence Requirements for
Pharmaceutical Products: Document for Public Opinion.

• PANDRH meaning is Pan American Network for Drug Regulxtory
Harmonization and other full form of PANDRH definition take part in below
table. There are 3 different meaning of PANDRH acronym in the table which
are compilation of PANDRH abbreviation such as Medical, America, Health,
Military, Organizations etc

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PANDRH’s general objectives are to:

• Strengthen the regulatory functions and systems of the countries of the
Region, promoting cooperation and sharing among countries, with the Pan
American Health Organization (PAHO), and with other regional and
international organizations, civil society, industry associations, and academia.

• Develop, approve, and implement common proposals (projects, joint activities,
technical documents, guidelines, work plans, etc.) for the regulation of health
technologies, considering international guidelines and standards for
regulatory convergence.

• Develop core competencies aimed at supporting and strengthening good
regulatory practices and regulatory science in the Member States with the
goal of achieving regulatory convergence in the Region. Encourage the NRAs
of the Region to develop and maintain well-structured organizations to
achieve effective regulatory functions as an essential part of health systems,
in accordance.

• The Components of PANDRH are The Pan American Conference on Drug
Regulatory Harmonization (PANDRH), the Steering Committee (SC), the
Technical Working Groups (WGs) in the areas considered as a priority by the
Conference, and the Secretariat.

 

 

SADC

HISTORY

Southern African Development Community

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• SADC (Southern African Development Community) is a regional organisation
consisting of 14 Member Countries (Angola, Botswana, Congo (DR), Lesotho,
Malawi, Mauritius, Mozambique, Namibia, Seychelles, South Africa, Swaziland,
Tanzania, Zambia and Zimbabwe).

• The Southern African Development Community (SADC) is an inter-governmental
organization headquartered in Gaborone, Botswana.

 

 

 

 

 

 

 

Its goal is to further regional socio-economic cooperation and integration as well as
political and security cooperation among 16 countries in southern Africa.[

The Southern African Development Community (SADC) has been in existence since
1980, when it was formed as a loose alliance of nine majority-ruled States in Southern
Africa known as the Southern African Development Coordination Conference
(SADCC), with the main aim of coordinating development projects in order to lessen
economic dependence on the then apartheid South Africa.

The founding Member States are: Angola, Botswana, Lesotho, Malawi, Mozambique,
Swaziland, United Republic of Tanzania, Zambia and Zimbabwe.

SADCC was formed in Lusaka, Zambia on April 1, 1980, following the adoption of the
Lusaka Declaration – Southern Africa: Towards Economic Liberation.

The transformation of the organization from a Coordinating Conference into a
Development Community (SADC) took place on August 17, 1992 in Windhoek,
Namibia when the Declaration and Treaty was signed at the Summit of Heads of State
and Government thereby giving the organization a legal character.

The Member States are Angola, Botswana, the Democratic Republic of Congo,
Lesotho, Madagascar, Malawi, Mauritius, Mozambique, Namibia, Seychelles, South
Africa, Swaziland, United Republic of Tanzania, Zambia and Zimbabwe
SADC headquarters are located in Gaborone, Botswana.

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he Southern African Development Community (SADC) and India have been called
upon to take advantage of the emerging economic opportunities for the accelerated
mutually beneficial trade, investment and development of India and the SADC Region.

 

WORLD HEALTH ORGANISATION :
The World Health Organization is a specialized agency of the United Nations responsible for
international public health. The WHO Constitution states its main objective as “the attainment by
all peoples of the highest possible level of health”.

Headquartered in Geneva, Switzerland, it has six regional offices and 150 field offices worldwide.

 

WHO GMP Guidelines :

1. Good Manufacturing Practices (GMP, also referred to as ‘cGMP’ or ‘current Good
Manufacturing Practice’) is the aspect of quality assurance that ensures that
medicinal products are consistently produced and controlled to the quality standards
appropriate to their intended use and as required by the product specification.

2. GMP defines quality measures for both production and quality control and defines
general measures to ensure that processes necessary for production and testing are
clearly defined, validated, reviewed, and documented, and that the personnel,
premises and materials are suitable for the production of pharmaceuticals and
biologicals including vaccines .

3. GMP also has legal components, covering responsibilities for distribution,

contract manufacturing and testing, and responses to product defects and

complaints. Specific GMP requirements relevant to classes of products such

as sterile pharmaceuticals or biological medicinal products are provided in a

series of annexes to the general GMP requirements.

4. Good manufacturing practice (GMP) is that part of a quality management system
to ensure that products are consistently produced and controlled to the quality
standards appropriate to their intended use and as required by the marketing
authorization. GMP is aimed primarily at diminishing the risks inherent in any
pharmaceutical production; which may broadly be categorized into two
groups: (1) cross-contamination/mix-ups and (2) false labelling. Above all,
manufacturers must not place patients at risk due to inadequate safety, quality or
efficacy. For this reason, risk assessment has come to play an important role in
WHO quality assurance guidelines.

 

16. Good practices in production

16.1 Principle. Production operations must follow clearly defined procedures in accordance
with manufacturing and marketing authorizations, with the objective of obtaining products of
the requisite quality.

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General :

All handling of materials and products, such as receipt and cleaning, quarantine, sampling, storage,
labelling, dispensing, processing, packaging and distribution should be done in accordance with
written procedures or instructions and, where necessary, recorded .

Deviation from instructions or procedures should be avoided as far as possible. If deviations occur,
they should be in accordance with an approved procedure. The authorization of the deviation should
be approved in writing by a designated person, with the involvement of the QC department, when
appropriate.

Checks on yields and reconciliation of quantities should be carried out as necessary to ensure that
there are no discrepancies outside acceptable limits.

Operations on different products should not be carried out simultaneously or consecutively in the
same room or area unless there is no risk of mix up or cross-contamination.

At all times during processing, all materials, bulk containers, major items of equipment, and, where
appropriate, the rooms and packaging lines being used, should be labelled or otherwise identified
with an indication of the product or material being processed, its strength (where applicable) and
the batch number. Where applicable, this indication should also mention the stage of production. In
some cases it may be useful to also record the name of the previous product that has been
processed.

Access to production premises should be restricted to authorized personnel

Normally, non-medicinal products should not be produced in areas or with equipment destined for
the production of pharmaceutical products

In-process controls are usually performed within the production area. The performance of such in-
process controls should not have any negative effect on the quality of the product or another
product (e.g. cross-contamination or mix up).

Prevention of cross-contamination and bacterial contamination during production

When dry materials and products are used in production, special precautions should be taken to
prevent the generation and dissemination of dust. Provision should be made for proper air control
(e.g. supply and extraction of air of suitable quality).

Contamination of a starting material or of a product by another material or product must be
avoided. This risk of accidental cross-contamination arises from the uncontrolled release of dust,
gases, particles, vapours, sprays or organisms from materials and products in process, from residues
on equipment, from intruding insects, and from operators’ clothing, skin, etc. The significance of this
risk varies with the type of contaminant and of the product being contaminated. Among the most
hazardous contaminants are highly sensitizing materials, biological preparations such as living
organisms, certain hormones, cytotoxic substances, and other highly active materials. Products in
which contamination is likely to be most significant are those administered by injection or applied to
open wounds and those given in large doses and/or over a long time.

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2 Cross-contamination should be avoided by taking appropriate technical or organizational
measures, for example:

carrying out production in dedicated and self-contained areas (which may be required for products
such as penicillins, live vaccines, live bacterial preparations and certain other biologicals);

(a) conducting campaign production (separation in time) followed by appropriate cleaning in
accordance with a validated cleaning procedure;

(b) providing appropriately designed airlocks, pressure differentials, and air supply and extraction
systems;

(c) minimizing the risk of contamination caused by recirculation or reentry of untreated or
insufficiently treated air;

(d) wearing protective clothing where products or materials are handled;
(e) using cleaning and decontamination procedures of known effectiveness;
(f) using a “closed system” in production;
(g) testing for residues;
(h) using cleanliness status labels on equipment.

3. Measures to prevent cross-contamination and their effectiveness should be checked periodically
according to SOPs

4. Production areas where susceptible products are processed should undergo periodic
environmental monitoring (e.g. for microbiological and particulate matter, where appropriate).

Processing operations

1. Before any processing operation is started, steps should be taken to ensure that the work
area and equipment are clean and free from any starting materials, products, product
residues, labels or documents not required for the current operation.

2. Any necessary in-process controls and environmental controls should be carried out and
recorded.

3. Means should be instituted of indicating failures of equipment or of services (e.g. water, gas)
to equipment. Defective equipment should be withdrawn from use until the defect has been
rectified. After use, production equipment should be cleaned without delay according to
detailed written procedures and stored under clean and dry conditions in a separate area or
in a manner that will prevent contamination.

4. Time limits for storage of equipment after cleaning and before use should be stated and
based on relevant data.

5. Containers for filling should be cleaned before filling. Attention should be given to avoiding
and removing any contaminants such as glass fragments and metal particles.

6. Any significant deviation from the expected yield should be recorded and investigated.
7. Checks should be carried out to ensure that pipelines and other pieces of equipment used

for the transportation of products from one area to another are connected in the correct
manner.

8. Pipes used for conveying distilled or deionized water and, where appropriate, other water
pipes should be sanitized and stored according to written procedures that detail the action
limits for microbiological contamination and the measures to be taken.

 

Packaging operations

When the programme for packaging operations is being set up, particular attention should be given
to minimizing the risk of cross-contamination, mix ups or substitutions. Different products should

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not be packaged in close proximity unless there is physical segregation or an alternative system that
will provide equal assurance.

Before packaging operations are begun, steps should be taken to ensure that the work area,
packaging lines, printing machines and other equipment are clean and free from any products,
materials or documents used previously and which are not required for the current operation. The
line clearance should be performed according to an appropriate procedure and checklist, and
recorded.

The name and batch number of the product being handled should be displayed at each packaging
station or line.

Normally, filling and sealing should be followed as quickly as possible by labelling. If labelling is
delayed, appropriate procedures should be applied to ensure that no mix ups or mislabelling can
occur.

The correct performance of any printing (e.g. of code numbers or expiry dates) done separately or
in the course of the packaging should be checked and recorded. Attention should be paid to printing
by hand, which should be rechecked at regular intervals.

Special care should be taken when cut labels are used and when overprinting is carried out off-line,
and in hand-packaging operations. Roll-feed labels are normally preferable to cut labels in helping to
avoid mix ups. Online verification of all labels by automated electronic means can be helpful in
preventing mix ups, but checks should be made to ensure that any electronic code readers, label
counters, or similar devices are operating correctly. When labels are attached manually, in-process
control checks should be performed more frequently.

Regular online control of the product during packaging should include at a minimum checks on:

(a) the general appearance of the packages;

(b) whether the packages are complete;

(c) whether the correct products and packaging materials are used;

(d) whether any overprinting is correct;

(e) the correct functioning of line monitors.

Samples taken away from the packaging line should not be returned.

 

 

WHO good manufacturing practices for pharmaceutical products: Main principles

https://cdn.who.int/media/docs/default-source/medicines/norms-and-
standards/trs986annex2.pdf?sfvrsn=320c9e62_1&download=true

 

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WHO good manufacturing practices for active pharmaceutical ingredients (bulk drug
substances)

https://cdn.who.int/media/docs/default-source/medicines/norms-and-
standards/gmpactivepharmaceuticalingredientstrs957annex2.pdf?sfvrsn=26283c1d_1&dow
nload=true

 

WHO good manufacturing practices for the manufacture of pharmaceutical excipients

https://cdn.who.int/media/docs/default-source/medicines/norms-and-
standards/guidelines/production/trs885-annex5-who-gmp-for-the-manufacture-of-
pharmaceutical-excipients.pdf?sfvrsn=f6fd871f_6&download=true

 

WHO good manufacturing practices for pharmaceutical products containing hazardous
substances

 

https://cdn.who.int/media/docs/default-source/medicines/norms-and-
standards/who-good- manufacturing-practices-for-pharmaceutical-
products-containing-hazardous-substances.pdf?sfvrsn=58a6690b_1&download=true

Reference :

https://www.who.int/teams/health-product-policy-and-standards/standards-and-
specifications/gmp

 

 

 

 

 

 

 

 

 

 

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REGULATORY REQUIREMENTS FOR REGISTERATION OF DRUGS IN
EMERGING MARKET :

 

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REGULATORY REQUIREMENTS FOR REGISTERATION OF DRUGS IN

EMERGING MARKET :

 

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Reference :

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https://www.researchgate.net/publication/336207122_Comparative
_study_of_Regulatory_requirements_of_Drug_Product_in_Emerging
_market

 

DRUG REGULATORY APPROVAL PROCESS FOR EMERGING ECONOMIES
Drug Regulatory Approval Process in India

 

Introduction

 

Current federal law requires that a drug be the subject of an approved marketing application before it is
transported or distributed across state lines. Because a sponsor will probably want to ship the investigational
drug to clinical investigators in many states, it must seek an exemption from that legal requirement. The IND is
the means through which the sponsor technically obtains this exemption from the FDA

FDA’s role in the development of a new drug begins when the drug’s sponsor (usually the manufacturer or
potential marketer) having screened the new molecule for pharmacological activity and acute toxicity
potential in animals, wants to test its diagnostic or therapeutic potential in humans. At that point, the
molecule changes in legal status under the Federal Food, Drug, and Cosmetic Act and becomes a new drug
subject to specific requirements of the drug regulatory system.

The IND application must contain information in three broad areas: 1. Animal pharmacology and toxicology
studies Preclinical data to permit an assessment as to whether the product is reasonably safe for initial testing
in humans. Also included are any previous experience with the drug in humans (often foreign use)

2 Manufacturing information: Information pertaining to the composition, manufacturer, stability, and controls
used for manufacturing the drug substance and the drug product. This information is assessed to ensure that
the company can adequately produce and supply consistent batches of the drug

3. Clinical protocols and investigator information: Detailed protocols for proposed clinical studies to assess
whether the initial-phase trials will expose subjects to unnecessary risks. Also, information on the
qualifications of clinical investigators professionals (generally physicians) who oversee the administration of
the experimental compound to assess whether they are qualified to fulfill their clinical trial duties. Finally,
commitments to obtain informed consent from the researd subjects, to obtain review of the study by an
institutional review board (IRS) and to adhere to the investigational new drug regulations.

Once the IND is submitted, the sponsor must wait 30 calendar days before initiating any clinical trials. During
this time, FDA has an opportunity to review the IND for safety to assure that research subjects will not be
subjected to unreasonable risk.

 

 

 

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Overview of Drug Regulatory Approval Process

 

The India’s parliament passed the Drug and Cosmetic Act 1940 and Rules 1945 for the regulation of import,
manufacture, distribution and sale of drugs and cosmetics The Central Drugs Standard Control Organization
(CDSCO), and the office of its leader, the Drugs Controller General (India) [DCGI] was established.

The Indian government added schedule Y to the Drug and Cosmetic Rules 1945 in 1988 which provides the
guidelines and requirements for clinical trials, which was further revised in 2005 to bring it at same level with
globally established procedure. The changes includes, establishing definitions for Phase I-IV trials and clear
responsibilities for investigators and sponsors

In 2006 the clinical trials were further divided into two groups. In one group (category A) clinical trials are
conducted and other markets with capable and adult regulatory systems whereas the remaining are fall into
another group (category B) other than A.

Clinical trials of category A (approved in the US, Britain, Switzerland, Australia, Canada, Germany, South Africa,
Japan and the European Union) are appropriate for fast tracking in India, and are expected to be accepted
within 2 months. The clinical trials of category B are under more analysis and approve within 16 to 18 weeks.

An application for the conduction of clinical trials in India should be submitted along with the data of
chemistry, manufacturing, control and animal studies to DCGI. The date of the trial protocol, investigator’s
brochures, and informed consent documents should also be attached with the application. One copy of the
application must be submitted to the ethical committee and after the approval of DCGI and ethical committee
the clinical trials are conducted to determine the maximum tolerated dose in humans, adverse reactions, etc.

The Phase I clinical trials are conducted on healthy human volunteers. The therapeutic uses and effective dose
ranges are determined in Phase II trials in 10-12 patients at each dose level. The Phase III trials (confirmatory
trials) are conducted to generate data regarding the efficacy and safety of the drug in – 100 patients (at 3-4
centers) to verify efficacy and safety claims and Phase III trials should be conducted on a minimum of 500
patients spread across 10-15 centers, if the new drug substance is not marketed in any other country.

After the completion of clinical trials the new drug registration (using form # 44 along with full preclinical and
clinical testing information) is applied. The full information on the market condition of the drug in other
countries is also required other than the information on safety and efficacy. The information regarding
theprescription, samples and testing protocols, product monograph, labels, and cartons must also be
submitted.

The application can be review in 12-18 months. Figure 8.1 shows the new drug approval process of India. After
approved by the NDA, when a company is permitted to distribute and market the product, it is considered to
be in Phase IV trials, in which new uses or new populations, long-term effects, etc. are explored.

The drug approval process differentiates from one country to another. In some countries, only a single body
regulates the drugs and is responsible for all regulatory job such as approval of new drugs, issuing license for
manufacturing and inspection of manufacturing plants, e.g. in the USA, FDA performs all the functions. While
in some counties all jobs are not performed by a single regulatory authority, such as in India, this responsibility
is divided on Centralized and State authorities. The other issues where the difference appears are, time taken
for the sanction of a CTA application, time taken in appraisal of marketing authorization application,
registration fee, registration process and marketing exclusivity.

Some counties have two different appraisal processes as normal review process and accelerated review
process as in the USA, China, etc. and some countries have only a single appraisal process as in India. Similarly,
the design used for the presentation of file submitted for approval of drug is also different.

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Drug Regulatory Approval Process in China

 

The Chinese Ministry of Health planned drug regulation in 1963, for the management of new drugs.
The China’s State Pharmaceutical Administration in association with Ministry of Health in 1979,
published the New Drug Management Regulations. The first comprehensive Drug Administrative Law
was framed in 1985 in vision of protecting the public health and promoting the economic
developments in pharmaceuticals. This law was amended in 1999 by two additional provisions for
new drug approval and provisions for new biological product approval. The sanction process of new
drug applications (NDA) includes enough preclinical data for verification of drug’s safety and validation
of the initiation of clinical trials. In 2001 the Drug Administrative Law was further revised requiring
premarket testing, sanction for new drug products, and prohibits drug adulteration.

 

The State Food and Drug Administration (SFDA) is authorized by the drug administrative law to
approve new drugs for marketing. The new drug registration process also contains the clinical study
application and the new drug applications. The provincial drug administration authorities (PDAAs)

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should arrange the works of the official review of submitted materials, i.e. on-site examination and
sampling just after receiving the drug registration application. The aim behind this official review is to
assure the content and format of the submitted materials is in line with the requirements and all the
required materials have been submitted. After this review, the PDAAs send the qualified applications
to the SFDA for further review and the import drug registration application should be straight
submitted to SPDA by the applicant. SFDA’s Department of Drug Registration carefully reviews the
totality of the submitted materials, files the qualified applications and transmits all the materials of
qualified applications to the center for drug evaluation (CDE) directly attracted to SFDA. The CDE
decide whether the safety and effectiveness information submitted for a new drug are sufficient for
manufacturing and marketing approval and send the review report to SFDA. SFDA carefully consider
the recommendations and review the results of CDE and decides whether the drug registration is
done or not. The application can be approved and issues the certificate of drug approval and drug
approval number to the qualified applicant.

 

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POST APPROVAL REQUIREMENTS IN WHO THROUGH
PREQUALIFICATION PROGRAMME :

WHO prequalification of medicines is a service provided by WHO to assess the

quality, safety and efficacy of medicinal products. Originally, in 2001, the focus was

on medicines for treating HIV/AIDS, tuberculosis and malaria. In 2006, this was

extended to cover medicines and products for reproductive health and again in 2008,

to cover prequalification of zinc, for managing acute diarrhoea in children. At the end

of 2012, the WHO List of Prequalified Medicinal Products contained 316 medicines

for priority diseases.

 

 

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Certificate of a pharmaceutical product

This certificate conforms to the format recommended by the World Health

Organization

No. of certificate

Exporting (certifying country):

Importing (requesting country):

1. Name and dosage form of the product:

1.1. Active ingredient(s)2 and amount(s) per unit dose3:

For complete composition including excipients, see attached4:

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1.2. Is this product licensed to be placed on the market for use in the exporting

country?5 (yes/no)

1.3 Is this product actually on the market in the exporting country?

If the answer to 1.2. is yes, continue with section 2A and omit section 2B.

If the answer to 1.2 is no, omit section 2A and continue with section 2B6:

2.A.1. Number of product licence7 and date of issue:

2.A.2. Product licence holder (name and address):

2.A.3. Status of product licence holder8: (Key in appropriate category as defined in

note 8)

2.A.3.1. For categories b and c the name and address of the manufacturer producing

the dosage form is9:

2.A.4. Is a summary basis for approval appended?10 (yes/no)

2.A.5. Is the attached, officially approved product information complete and

consonent with the licence?11 (yes/no/not provided)

2.A.6. Applicant for certificate, if different from licence holder (name and address)12:

2.B.1. Applicant for certificate (name and address):

2.B.2. Status of applicant: (Key in appropriate category as defined in footnote 8)

2.B.2.1. For categories (b) and (c) the name and address of the manufacturer

producing the dosage form is:9

2.B.3. Why is marketing authorization lacking? (not required/not requested/under

consideration/refused)

2.B.4. Remarks13:

3. Does the certifying authority arrange for periodic inspection of the manufacturing

plant in which the dosage form is produced? (yes/no/not applicable)14

If not or not applicable, proceed to question 4.

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3.1. Periodicity of routine inspections (years):

3.2. Has the manufacture of this type of dosage form been inspected? (yes/no)

3.3 Do the facilities and operations conform to GMP as recommended by the World

Health Organization?15 (yes/no/not applicable)14

4. Does the information submitted by the applicant satisfy the certifying authority on

all aspects of the manufacture of the product16: (yes/no)

If no, explain:

Address of certifying authority:

Telephone:

Fax:

Name of authorized person:

Signature

Stamp and date

➢ The certificate of pharmaceutical product (abbreviated: CPP) is a certificate

issued in the format recommended by the World Health Organization (WHO),
which establishes the status of the pharmaceutical product and of the
applicant for this certificate in the exporting country;

➢ This certificate refers to a particular product whether or not it is sold in the country

of origin and also states that the manufacturer of the drug complies with GMP and
that they are regularly inspected by the national health authorities. A CoPP is
issued in the format which is recommended by WHO.

➢ The certificate of pharmaceutical product (CPP) was implemented to accelerate the
availability of new drugs in developing countries by providing evidence of the
quality of products and reducing the time to market through reliance on a prior
trusted analysis. However, the CPP format, issuing process and use have not been
revised since 1997 and there are significant differences among countries in regard
to requirements for CPP timing, terminology, and format. We sought to determine
current CPP practices versus national regulatory guidelines and to inform

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recommendations for the efficient use of the CPP based on the needs of the modern
regulatory environment..

 

➢ Objective of certification

A CoPP demonstrates that imported medication is of the relevant standard of quality,
safety and efficacy to allow marketing, rigorous testing and inspection in the exporting
country to be carried out by regulatory authorities and shows that it meets the relevant
standards and procedures of Good Manufacturing Practice (GMP) and improves the
product’s quality and health.

Who Can Apply
• The person/company that exports the product must present a complete

application for export certification.
• The qualification is intended for a drug that meets the criteria of the Act or the

criteria of the Food Drug and Cosmetic Act

 

Process of obtaining the certificate
• Applicant Contact Information
• Trade name (brand name of the drug product)
• Bulk Material Generic Name
• Applicant’s name
• Product License holder {List of manufacturing site on CPPP}
• Full Manufacturing Facility Address
• Facility Registration Number
• Countries importing
• Permission to release details
• Number of certificates required
• Certification Statement

a. Additional information

Foreign manufactured drugs Export certification from the country for the Foreign
Manufacturing sites Approved drug products NDA, ANDA, BLA or approval Letter /
Outer Container Label(s) / Package Insert / Package Container (Immediate)

Guideline for COPP form attachments:

a. All attachments will be required in two sets
b. Attachments should not be more than 5 pager
c. Applicant should consult with importing country for different types of information

COPP is generally issued within20 working days from the date of application and
issued certificate expires in 2 years from the date of notarization.

REFERANCE : https://www.who.int/teams/regulation-prequalification/regulation-and-
safety/rss/certification-scheme/model-certificate-of-a-pharmaceutical-product

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SOUTH AFRICA

➢ REGISTRATION AND LICENSING REQUIREMENTS 

 

• Regulatory Authority : South African Health Products Regulatory Authority
(SAHPRA)  Website of regulatory Authority : http://www.mccza.com

 

1. Fees for Drug Registration : USD 2000 (27,000 Rands)
2. Normal time taken for registration : 48 Months
3. Registration Requirement [Dossier Format]: ZA CTD
4. Whether plant inspection is mandatory : Yes
5. Requirement of Local agent/ Subsidiary : Subsidiary is Required to operate

locally The South African government has formed the South African Health
Products Regulatory Authority (SAHPRA) to oversee the country’s medical
device and drug markets.

6. SAHPRA is based on elements of South Africa’s Medicines Control Council
(MCC). SAHPRA replaces the Medicines Control Council (MCC).

7. The scope of the new Authority has expanded to include not only medicines,
but also medical devices including in vitro diagnostics, and aspects of radiation
control.

• The Medicines and Related Substances Act, 1965 (Act 101 of 1965), as
amended by Act 72 of 2008, together with Act 14 of 2015, provides for the
establishment of SAHPRA, a Schedule 3A public entity, which will operate as
a separate juristic entity, outside of the National Department of Health (NDoH).

 

• SAHPRA will be responsible for monitoring, evaluation, regulation,
investigation, inspection, registration and control of medicines, scheduled
substances, clinical trials, medical devices and related matters in the public
interest.

 

 

 

 

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KENYA

Obtain a Certificate for Pharmaceutical Products

 

PROCEDURE :

 

Apply In-Person:

1. Companies importing manufactured drugs from Kenya can request for
a Certificate for Pharmaceutical Products (CPP) from the Pharmacy
and Poisons Board (PPB) through the exporting pharmaceutical
manufacturing company in Kenya.

2. To do this, the Superintending Pharmacist / Pharmacist in Charge of
the exporting company in Kenya, can approach the Pharmacy and
Poisons Board Offices to make an application.

3. Here the applicant will be given an Certificate of a Pharmaceutical
Product form by the boards officer to fill and submit.

4. Fill in the application and attach the required documents for the
application. A list of the required documents can be found under the
Required Documents” section of this page.

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5. Proceed to pay the required application fees and attach the payment
receipt to the application document. The details of application fees to
be paid can be found under the “Fees” section of this page.

6. Submit the completed application form, requirements and payment
receipt to the Boards officer for inspections, verifications and approval.

7. The board will review the application and after inspections and
verifications, recommendations will be sent to the Board for further
review/action.

8. Upon successful review and approval of the application, the PPB
issues a CPP to the importing/applicant company via the exporting
company.

9. The process usually takes a period of 30 days to complete.

 

➢ Required Documents

• A formal application letter by the Superintending Pharmacist / Pharmacist in
Charge of the company, as registered with the Pharmacy and Poisons Board,
addressed to “The Registrar, Pharmacy and Poisons Board” detailing the
requesting the CPP.

• Filled in application form
• Proof of up-to-date registration of the company
• Proof of up-to-date registration of the product
• List of active ingredients (contents) in the medicine
• Detail of Name and dosage form of the product
• Product license / Marketing Authorization
• Premise license
• Manufacturing license.
• Details of applicant for certificate.
• Inspection certificate of manufacturing plant

Eligibility

• Individuals wishing to import drugs manufactured/packaged in Kenya for sale
are eligible to make the application.

 

Fees

• The CPP issuance fee is approximately 200 USD.

 

Validity

• The Certificate for Pharmaceutical Product shall be valid for five years.

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Instructions

How the CPP scheme operates

• The certificate recipient authority has in its national medicine legislation or
guidelines a requirement for the submission of a Certificate for a
Pharmaceutical Product (CPP) for products being imported into the country
as a support to ensure the quality of the product being imported. (In some
countries the CPP forms part of the dossiers to be submitted to the national
medicine regulatory authority (NMRA) to have a product registered by the
authority).

• The applicant/importing company requests a CPP from the certifying authority
through the exporting company.

• The certifying authority issues a CPP to the importing/applicant company via
the exporting company. (At the time of the development of the Scheme the
understanding was that a CPP would be sent directly to the recipient authority
by the issuing authority.

Required Information

• Exporting (certifying country) name
• Importing (requesting country) name
• Name and dosage form of the product: (In Kenya: / In importing country

(specify the country))
• Active ingredient(s) (2and amount(s) per unit dose
• Is this product licensed to be placed on the market for use in the exporting

country
• Is this product actually on the market in the exporting country
• Product licence / Marketing Authorization
• The name and address of Product licence holder
• The names and address of manufacturing/ packaging site where the dosage

form is produced
• officially approved product information complete and consonant with the

licence
• Applicant for certificate, if different from licence holder (name and address)
• Does the certifying authority arrange for periodic inspection of the

manufacturing plant in which the dosage form is produced?
• Do the facilities and operations conform to GMP as recommended by the

World Health Organization

Need for the Document

• Holders of this permit are allowed to advertise drugs for in Kenya.
• The Certificate for a Pharmaceutical Product (CPP) evidence of quality,

safety, efficacy review and approval. The CPP is based on the assumption
that the authorities issuing a CPP have the capacity to assess the quality,
safety, and efficacy (QSE) of the product they approve for marketing.

 

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Information which might help

• The Certificate for a Pharmaceutical Product CPP is administrative instrument
that requires a participating Member State (a certifying country), upon
application by a commercially interested party (the applicant company), to
certify/attest to the competent authority of another participating Member State
(the recipient country) that:

• a specific pharmaceutical product is authorized for marketing in the
certifying country, or if not, the reason why authorization has not
been accorded.

• the manufacturing facilities and operations conform to good
manufacturing practices (GMP) as recommended by WHO.

 

EGYPT : CERTIFICATE OF PHARMACEUTICAL PRODUCT

 

The certificate of pharmaceutical product CPP or CoPP is a certificate issued in the
format recommended by the Ministry of Health Egypt in Collaboration with World
Health Organization (WHO), which establishes the status of the pharmaceutical
product and of the applicant for this certificate in the exporting country

Procedure[edit]

‘Apply In-Person:

1. To apply to obtain a Certificate for Pharmaceutical Products the applicant
must first submit all the necessary documents required for the process to
the Egyptian Health Authority.

2. Refer to the “Required Documents” section of this procedure to know
more.

3. There must be evidence that the Drug products are manufactured
according to Good Manufacturing Practice (GMP). In the case of imported
drug products (from foreign country), the importer must submit evidence
that they are licensed to manufacture the drug products for sale in the
country of origin.

4. There must be evidence by the competent Health Authority, that the sale
of the drug products does not constitute a contravention of the Drug laws

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of that country. I.e. Certificate of Pharmaceutical Product (COPP) that
conforms to WHO format. The documents in respect of C1-3 shall be
authenticated by the Mission in that country. In countries where no
Egyptian Embassy or High Commission exists, any other Embassy or
High Commission of any Commonwealth or North African countries can
authenticate.

5. The applicant shall submit two (2) MA (Marketing Authorization) made out
in accordance with the Agencies format. In Egypt Authorities may not be
willing to accept the exported drugs until the final approval of a CPP has
been submitted.

6. Safety and efficacy of the medicine is a requirement for a CPP certificate
from the manufacturing source country, which does not provide additional
assurances to the quality of the medicine.

7. Copy of current Annual License to Practice as a Pharmacist for the
Superintendent Pharmacist issued by Pharmacists Authority should be
submitted.

8. Copy of Current Certificate of Registration Retention of Premises is issued by
Pharmacists Authority.

9. Comprehensive Certificate of analysis of the batch of drug products submitted for
registration processing shall be submitted.

10. Annex 2 of the decree lists the generic groups/boxes and their forms. If a new
pharmaceutical form is created, it can be added to Annex 2 after getting the
approval of Technical Committee for Supervising Drugs at CAPA.

11. After all the documents have been submitted, a drug product cannot be marketed
in Egypt, unless the exporter has produced a certificate of pharmaceutical
product issued by Central Administration for Pharmaceutical Affairs General
Inspection Department in Egypt. Egypt, accepts a Certificate Pharmaceutical
Products at the time of Marketing Authorization. Current law requires that a CPP
must be submitted from the country of origin.

Required Documents[edit]

• Covering letter indicating the documents contained in the file.
• An application form for registration/duly filled in and signed.
• Certificate or origin and free sale issued from the Ministry of Health in the

country of origin, legalized by the Egyptian Embassy or Consulate in that
country, including clearly:

• Name and address of the manufacturer.
• Name and strength of the product, name & quantity of active

ingredients.
• That the product is freely sold in its country of origin under the

same name and composition.
• Certificate of G M P for the industry manufacturing the

Pharmaceutical qualities.
• Five copies of the complete formula, quantitative, qualitative of

active and inactive ingredients, colouring matter, etc.
• Certificate of analysis in 2 copies, from the manufacturing firm,

in which it is also clarified the same batch number of the

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samples submitted for analysis. It should also state the dates of
preparation & expiration of the product, if any.

• List of countries where the product is registered & marketed.
• Agency agreement of Authorization for Registration. This should be

granted to an Egyptian citizen or a scientific office in Egypt, and must be
legalized by the Egyptian Embassy of Consulate in the country of Origin.

• A governmental postal order for the fee of five Egyptian Pounds to the
order of “The General Administration of Pharmacy /Ministry of Health /
A.R.E.

• A Subsidiary file containing a copy of each document submitted in the
original file.

 

 

 

 

 

 

 

 

 

ALGERIA : CERTIFICATE OF PHARMACEUTICAL PRODUCT

Certificate of Pharmaceutical Product may be required by the Manufacturer of a
pharmaceutical product when its drugs are required to be registered with the
NAFDAC before import. It is certification recommended by the World Health
Organization for authentication quality of a pharmaceutical product.

Procedure[edit]

Apply In-Person:

1. To apply for a Certificate of Pharmaceutical Product (COPP) in person,
the applicant has to visit the office of the National Agency for Food and
Drug Administration and Control.

2. The contact link of NAFDAC can be found in the following contact link
3. Visit the office and obtain an application form for Certificate of

Pharmaceutical Product (COPP) with respect to the requirement from the
relevant department.

4. Complete the form with appropriate information under relevant sections.
Attest it with your signature once completed.

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5. Once completed filling the application form, make sure that you attached
all the documents listed in the “Required documents” section of this page.

6. Then, submit it in person to the relevant authority at the office. Make the
stipulated payment as directed by the officials.

7. After submission, the application and other documents will be forwarded
for examination and verification processes.

8. Once the verification and validation processes are over, the application
will be approved and the officials will proceed to take required steps to
issue the certificate.

9. When the document is ready to be collected, the applicant will receive a
notification from the office through email or phone call regarding the
collection and the applicant can collect it by any applicable means.

10. Meanwhile, the applicant can also contact the office regarding the
application status.

Apply Online

1. To apply for a Certificate of Pharmaceutical Product (COPP) online,
the applicant must visit the following E-license application link

2. If you have registered with the Nigeria Single Window Trade Portal,
you can enter the user credentials in the fields provided and click
“Login” button.

3. Otherwise, the person who wants to obtain a registration must
contact/visit the Federal Inland Revenue Services office where he/she
obtained the TIN and provide one valid email and mobile number,
together with other company’s identification details as per FIRS
requirement.

4. After that, he/she can visit the following link and make the
registration: apply online.

5. You will have to just enter TIN number, Email ID, text image in the
respective fields and click “Validate” button.

6. Follow the instructions and complete the registration, then the
applicant must be proceeding to apply for and obtain the certificate of
analysis.

7. Visit the following E-license application link and enter the user details
in the respective fields, then click “Login” button.

8. NAFDAC e-License main page will be displayed. For digitization of
certificates/permits, please click ‘Permit/Certificate Enrolment’ option
on the left side.

9. Start completing the tabs one-by-one by entering the required details
and making the appropriate selections by following the on-screen
instructions.

10. After successfully completing all the tabs, click “Submit” button to
submit the application form. Click “Yes” button in the dialogue that
appears.

11. Click “ok” button in the next tab. An email notification is immediately
sent to your registered email address.

12. On submission, the application and other documents will be forwarded
for examination and verification processes.

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13. In the portal, you can find a tab named Support information tab provides a
general status of application and Application Progress Indicator shows the
current status of your application at NAFDAC.

14. Where there is a query on an application, an email notification is
immediately sent to your registered email address.

15. Respond to queries raised, by using the ‘search’ function and ‘Support
information’ tab. Make the appropriate changes by following the on-
screen instructions and update the application.

16. Onceall the information is found sufficient, the application will be
approved and the officials will proceed to take required steps to issue
the certificate.

17. When the Certificate is ready to be downloaded, a “print view” button
will appear in the portal on the top of your application. Click that to
download your certificate

 

Required Documents[edit]

• Completed application form
• Proof of company registration
• Applicant Identification proof
• Tax Identification Number
• Relevant Inspection/Quality Analysis report
• Proof of Power of Attorney (for companies outside Nigeria)
• Proof of payment (if any)
• Any supporting document (as instructed)

Required Information[edit]

• Company Name and Type
• Tax Identification Number
• Registration Certificate Number
• Incorporation Date
• Company physical and mailing address
• Contact number and email address
• Applicant names
• Source and category of the product
• Product Description and HS code
• Manufacturer name and address
• Particulars of the product
• Card details

 

 

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