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▪ Class : M.Pharm
(Department of Regulatory Affair)

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➢ 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 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.

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• 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.

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

• 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

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A key difference 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.

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• ASEAN – Association of Southeast
Asian Nations

VARIOUS • APEC – Asia-Pacific Economic

• EAC – Economic Advisory Council

• GCC – Gulf Cooperation Council

• PANDRH – Pan American Network for

GLOBE :- Drug Regulatory Harmonization

• SADC – Southern African
Development Community

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• 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 – • ASEAN brings together ten Southeast Asian states – Brunei,

Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines,

Association Singapore, Thailand and Vietnam – into one organisation

of Southeast • Purpose : The ASEAN Declaration states that the aims and purposes

of the Association are:

Asian Nations • (1) to accelerate economic growth, social progress and cultural

development in the region

• (2) to promote regional peace and stability through abiding respect for

justice and the rule of law in the relationship among countries

region and to promote regional peace and stability through abiding

respect for justice and the rule of law in the relationship among


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➢ 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
❑APEC – Asia- be selected for a three-year term. It develops and offers technical

& advisory support and information management,

Pacific communications & public outreach programs

➢ 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 – Economic Advisory Council

• 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.

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.

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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.

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.

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❑ GCC – Gulf Cooperation Council

• 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

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PANDRH – Pan American Network for Drug
Regulatory Harmonization

• 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 Regulatory
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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SADC – Southern African Development Community

• 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.

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• 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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• 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 .

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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.

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Certificate of a pharmaceutical product

➢ 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

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

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• 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

• 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

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• 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

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• 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

SOUTH 4. Whether plant inspection is mandatory : Yes

5. Requirement of Local agent/ Subsidiary : Subsidiary is

AFRICA 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.

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• Apply In-Person:

• 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.

• 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

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

• 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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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.

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

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

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

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

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➢ 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

• 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

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• 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

• 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.

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Certificate of analysis in 2 copies, from the manufacturing firm, in which it is also
clarified the same batch number of the 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.

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➢ 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.

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

➢Copy of Current Certificate of Registration Retention of Premises is issued by Pharmacists

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

➢ 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.

➢ 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.

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➢ .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.

➢ 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

➢ 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 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.

➢ 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.

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