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Regulatory requirements of EU,
MHRA,TGA AND ROW COUNTRIES

PRESENTED TO :-

DR. SANJULA BABOOTA

DR. JAVED ALI PRESENTED BY:-

DEPT.– PHARMACEUTICS PRERNA KAPOOR

SCHOOL OF PHARMACEUTICAL M.PHARM (PHARMACEUTICS)
EDUCATION AND RESEARCH

1ST SEMESTER
JAMIA HAMDARD

SCHOOL OF PHARMACEUTICAL
EDUCATION AND RESEARCH

JAMIA HAMDARD

 

contents

1. EUROPEAN UNION (EU)

2. MEDICINES AND HEALTHCARE PRODUCTS REGUALTORY
AGENCY (MHRA)

3. ROW COUNTRIES (ROW)

4. THERAPEUTIC GOODS ADMINISTRATION (TGA)

5. SUMMARY AND CONCLUSION

6. REFERENCES

 

European union
 The European Union (EU) is a political and economic union of 28 member states that are

located primarily in Europe.

 The EU has developed an internal single market through a standardized system of laws that
apply in all member states in those matters (only) where members have agreed to act as
one.

 Established under the name in1992 by the Treaty on European Union (the Maastricht
Treaty)

European medicines agency

 The European Medicines Agency (EMA) is a European Union agency for the evaluation of
medicinal products. Prior to 2004, it was known as the European Agency for the Evaluation
of Medicinal Products or European Medicines Evaluation Agency (EMEA).

 Its objective is to enforce a transparent process for development, consultation ,finalization
and implementation of pharmaceutical guidelines.

 

 EMA protects public & animal health by ensuring all medicine available in the market
of EU are safe, effective and of high quality.

 The agency is responsible for the scientific evaluation, supervision & safety
monitoring of the medicines developed by pharmaceutical companies for the use in
EU.

 EMA and member states cooperate and share expertise in the assessment of new
medicines and of new safety information.

 By working closely together the member states reduce duplication, share the
workload & ensure the effective and efficient regulation of medicines across the EU.

 Generally drug approval process in Europe occur in two steps :-

1. Clinical trial application which is approved by Member states

2. Marketing authorization application (MAA) which is approved by both Centre and
Member states.

 

MARKETING AUTHORIZATION APPLICATION

 Process of reviewing and assessing the dossier to support a medicinal product in
view of its marketing finalized by granting of a document is called marketing
authorization (MA). This process is performed within a legislative framework
which defines the requirements necessary for application to the concerned
regulatory authority, details on the assessment procedure (based on quality,
efficacy and safety criteria) and the grounds for approval or rejection of the
application, and also the circumstances where a marketing authorization already
granted may be withdrawn, suspended or revoked.

 The application dossier for marketing authorization is called a Marketing
Authorization Application (MAA) in the European Union and other countries, or
simply registration dossier.

 Basically, this consists of a dossier with data proving that the drug has quality,
efficacy and safety properties suitable for the intended use, additional
administrative documents, samples of finished product or related substances and
reagents necessary to perform analysis of finished product as described in that
dossier.

 

 The content and format of the dossier must follow rules as defined by
the competent authorities. For example, since 2003, the authorities in
the United States, the European Union and Japan ask for the
Common Technical Document (CTD) format, and more recently, its
electronic version – the electronic Common Technical Document
(eCTD).

 The application is filed with the competent drug regulatory authority
in the concerned country, which can be either be an independent
regulatory body or a specialized department in the ministry of health.

 In accordance with local legislation, the resulting document allowing
the applicant to market the product may be more detailed (in addition
to data identifying the product and its marketing authorization holder,
it may contain addresses of all manufacturing sites, appended
labeling, artwork of packaging components, etc.) until a one-page
document called certificate of registration (and containing minimal
data identifying the product and its source).

 

ROLE OF EMA

 EMA plays a crucial role in the regulation of medicines in Europe. On the
basis of scientific research carried out it grants or refuses, changes or
suspects marketing authorizations of medicines that have been
submitted via the centralised procedure.

 Right of initiative- it can propose new or amend legislation for the
pharmaceutical sector.

 Implementation – it can adopt measures as well as oversee the correct
application of EU law on pharmaceuticals.

Global outreach- it ensures appropriate collaboration with international
partners and promotes the EU regulatory framework globally.

 

AUTHORIZATION AND SUPERVISION OF
MANUFACTURERS

Manufacturers , importers , distributors of medicines in EU must be
licensed before they can carry out such activities.

 The regulatory authorities of each member state are responsible for
granting licences of the activities taking place in the respective states.

 All manufacturing or importing license are entered into EudraGMP, the
publicly available European database operated by EMA.

Manufactures listed in the application of medicines to be marketed in the
EU are inspected by the EU marketing authority

 Inspection outcome can be assessed by all member states and are made
publicly available through the EudraGMP.

 

 In order to be imported into EU , an active pharmaceutical ingredient
need to be accompanied by written conformation issued by the
competent authority of country where it is produced, confirming that the
good manufacturing process applied is at least equivalent to the
recognised EU GMP standard.

 Every batch of medicines must be certified as having been
manufactured and testes in accordance with the GMP and in
conformance with the MAA before it can be released into the market of
EU.

 If the product is manufactured outside the EU and has been imported,
it needs to undergo full analytical testing in the EU.

 

TYPES OF PROCEDURES

Various types of procedures for drug approval :-

Centralized

Decentralized

Mutual Recognition

National Procedure

 

CENTRALISED PROCEDURE

 In this type of procedure marketing authorization is given to
applicant which is valid in all member states of Europe.

MAA is evaluated by Reporter and report is submitted to European
commission for final approval within 210 days.

 It is compulsory for :-

1. Biotechnologically derived medicines.

2. Medicines for Cancer , AIDS , Diabetes and for some autoimmune
diseases.

3. Orphan medicines.

 

CHMP decision on
MAA Comments by CHMP need of oral

(DAY-170) explanation by
applicant(DAY-180)

Start of procedure Joint assessment Oral explanation by
(DAY-1) report from co- applicant RESTART

reporter(DAY-150) CLOCK (DAY-181)

Assessment report Submission of Final draft of english
from co-operator response by applicant spc, leaflet & labelling

(DAY-70) (DAY-121) of applicant to co-
reporter , EMA CHMP

(DAY-185)

CHMP provide CHMP forwards to
comments applicant list of

questions (DAY-120)
(DAY-115) STOP CLOCK CHMP opinion (DAY-

210)

 

Decentralized Procedure

 This procedure is used to market the product in more than
one member state (CMS) simultaneously.
Used for product which do not come under the category of
centralized procedure.
Time taken – 210 days

 

70 Days 35 Days

RMS distributes the
Applicant submits

RMS & CMS validates preliminary
application to RMS &

the application assessment report to
CMS

CMS

15 Days
RMS sends
preliminary RMS sends draft

Clock stops, Applicant
assessment report assessment report to

responds, clock runs
and all comments of CMS and applicant

CMS to applicant

90 Days or
less

CMS approves the MAA in RMS & each
assessment report of the CMS

 

Mutual Recognition Procedure (MRP)

Marketing authorization is given to applicant for
states(Concerned member states) in which he want to sell
drugs other than previously approved states (Reference
member states).

 Dossier send to all CMS by applicant with required
information.

 RMS sends a report/decision to CMS

 Time taken – 390 days

 

MAA issued to applicant

990 days
CMS approves the application

CMS reviews the report

990 days
CMS sends report to RMS

RMS reviews application and make a report

Application to RMS & CMS

 

NATIONAL PROCEDURE

 The national procedure is like the other procedures but in this case
only one member state is involved. The documents submitted to an
authority are very specific to that particular authority and evaluation
of the application is carried out by the same member state. The
evaluation time for an application for a national marketing
authorization is 210 days from the receipt of the application.

 But this procedure is stringently limited from 1 January 1998 to the
early phase of mutual recognition (granting of the marketing
authorization by the Reference Member State) and to medicinal
products which are not to be authorized in more than one Member
State.

 

TYPES OF APPLICATION FOR EU

CLASS DETAILS

FULL DOSIER CONTAINS COMPLETE CTD
MODULES

GENERIC PURE GENERIC APPLICATION

GENERIC, ADDITIONAL DATA HYBRID

BIO SIMILAR GENERIC BIOTECH PRODUCTS

BIBLIOGRAPHIC APPLICATION , PRE-CLINICAL AND CLINICAL
WELL ESTABLISHED USE DATA

FIXED COMBINATIONS PRE CLINICAL AND CLINCICAL
PRODUCT DATA FOR COMBINATION

INFORMED CONSENT INNOVATORS GENERIC
PRODUCT ( DUPLICATE
DOSIER)

 

PRINCIPLES DIFFERENCES BETWEEN FDA, EU , INDIA

 

 

MHRA
The Medicines and Healthcare products Regulatory Agency (MHRA) is an
executive agency of the Department of Health of United Kingdom.

MCA

MHRA

MDA

The MHRA was set up in April 2003 tobring together the functions of the
Medicines Control Agency (MCA) and the Medical Devices Agency (MDA).

The MHRA is responsible for ensuring that medicines andmedical devise
work, and are acceptably safe.

 

Functions of MHRA

The MHRA has
no interest in Mechanism of action

these early Drug

stages of drug discovery
Preformu-

development. lation and
laboratory
tests.

MHRA comes in
play when the
company wants
to start clinical
trials in
patients.

 

FUNCTIONS OF MHRA

 

WHAT IS MARKETING AUHTORISATION?

• Before any medicine can be used to treat people inthe UK, a marketing
authorization, from the MHRA is required.

• The MHRA operates a system of licensing before the marketing of medicines.
• Medicines which meet the standards of safety,quality and efficacy are granted a

marketing authorization (previously a product license), which is normally
necessary before they can be prescribed or sold.

• New biological or chemicalcompounds.
• Different brands of existingmedicines.
• Generics (identical but cheaperversions of existing brandedmedicines)
• New forms of existing medicines, such as syrups, patches, or injections.
• New uses for existing medicines, such as different patient groups or different

conditions.

 

PROCESS FOR LICENSING

 

Types of procedures

Procedures

Mutual
Centralized National Decentralized

recognition

Applications are generally submitted by the pharmaceutical industry, but anyone
with thenecessary supporting data may apply for alicense.

 

Centralized procedure

In the European Union (EU), a company may submit a single application to

the European Medicines Agency (EMEA) for a marketing authorization

(license) that is validsimultaneously in all EU MemberStates.

National procedure

Each EU Member State has its own procedures for the authorization of
medicines that fall outside the scope of the centralized procedure.

Applicants must submit an application to the competent authority of the
Member State. For e.g. In the UK, this is the MHRA.

 

DECENTRALISED PROCEDURE

Using the decentralized procedure, companies may apply for simultaneous
authorization in more than one EU country of products that have not yet been
authorized in any EU countryand that do not fall within the mandatory scope of
the centralized procedure.

MUTUAL RECOGNITION PROCEDURE

In the mutual recognition procedure, a medicine is first authorized in one EU
Member State, in accordance with the national procedures of that country.
Following this, further marketing authorizations can be sought from other EU
countries in a procedure whereby the countries concerned agree to recognize
the validity of the original, national marketing authorization.

 

TYPES OF APPLICATIONS

1) Fullapplications

 Applications for new active substances are described as’full
applications’.

2) Abridgedapplications

 Applications for medicines containing existing activesubstances
 are described as ‘abbreviated’ or ‘abridged applications’.

Existing drugs with new forms, routes and indications
 Sometimes, although the drug is the same, the new product has a different
strength or pharmaceutical form or is used by a different route or for different
clinical uses.

 

Existing drugs in newcombinations
 New combinations of existing drugs may also be proposed though they may
need a full data package tosupport them.

‘Well-established’ drugs andproducts

 The new product may include a drug substance which has such a well-established
medicinal use and an acceptable level of safety that the applicant company can submit
published data to support the safety and efficacy aspects of their application. Examples
here may include some over-the-counter (OTC)remedies.

3) Informed consent and change of ownershipapplications

 For commercial reasons companies may want to take over or duplicate a product
license held by another company. Wherethe first company agrees to this ‘informed
consent’ approach, the second company can get an exact copy license commonly known
as a ‘piggy-back’ license.

 Alternatively, where the ownership of the company changes hands and the new
owners need to take over the old product licenses. These applications are called
‘change of ownership’ applications.

 

PARALLEL IMPORTING AUTHORIZAION

 The UK Parallel Import Licensing Scheme allows medicinal products authorized
in other EU Member States to be marketed in the UK, provided the imported
products have no therapeutic difference from the equivalent UK products.

PARALLEL
IMPORT

APPLICATIONS

SIMPLE STANDARD COMPLEX

 

1) Simpleapplication

 This category will apply when the UK product and the product to be imported
from a Member state are made under license from the same licensor. This is the
traditional ‘common origin’criterion.

2) Standardapplication:

 This category will apply when the UK and imported products do not share a
common origin and the application is not ‘Complex’ .

 

3) Complexapplication:

 This category will apply when the UK and imported productsdo not share a common origin (as
defined above)and:

(a) the imported product contains a newexcipient.

(b) the imported product contains an active ingredient made by a different route from that used in
theUK product

(c) the imported product ise.g.

1. a controlled releasepreparation

2. a metered dose inhaler

3. a powder for inhalation

(d) the imported product isasterile product which is sterilized in a different way from the UK
product

(e) the imported product is asterile product in which the container is made from adifferent material
to the container of the UKproduct

(h) the manufacturer of the active ingredient contained in the imported product is different from
the manufacturer of the active ingredient contained in the UK product.

 

SUBMISSION OF APPLICATION

 All applications must follow the common technical dossier (CTD) format which
has been a requirement since2003.

 The preferred format for new marketing authorization (MA) applications is the
electronic Common Technical Dossier (eCTD).

 eCTD applications must be created according to thecurrent specifications.

 However, MHRA accept that many companies are not yetready to submit
applications in eCTD format. Therefore, it accepts applications in PDF-only
format also.

 

FAST TRACKING OF APPLICATION
 Under certain circumstances MHRA facilitates fast trackingof MA
applications.

 These circumstances are mainly categorized in two headings.

Fast tracking

For major
For shortfall of

therapeutic
medicines

breakthrough

 

Major therapeutic breakthrough
 Disease categories for which fast tracking of applications maybe applicable:

1. Chronic, debilitating diseases for which available treatmentsare
ineffective or otherwise inadequate.

2. Severe or life-threatening diseases for which available treatments are
ineffective or otherwise inadequate.

3. The emergence in a disease with wide-spread resistance to treatment with
currently available therapeuticagents.

 The emergence of a new disease entity which has severe or life- threatening
effects and for which currently available treatmentsare ineffective or otherwise

 

For shortfall of medicines

MHRA facilitates fast tracking when there is shortage of the essential or life
saving medicines to avoid harm to publichealth.

 In this case of scarcity of medicines MHRA communicates withDepartment
of Health and verifies the shortage.

 Note: For both the above situations, a decision to fast track an application
would mean that the assessment of the application is commenced out of turn,
ahead of its order in the sequence of submitted applications.

The documentation for such application should be consistent with legal
requirements and guidelines relating to applications for marketing
authorizations.

 

RENEWAL OF LICENSE

New Marketing authorizations (MAs)
are valid for five years and then may be
renewed on the basis of a re-evaluation of
the risk- benefit balance.

Once renewed, the marketing
authorization will be valid for an
unlimited period.
 Applications for renewal should be
submitted atleast six months before
expiry.

 

CANCELLATION OF LICENSE

 If MAs holder does not file an application for renewal within specified time,
MAs expiresautomatically.

 If the MAs holder does not wish to renew the license, a letter should be sent
indicating the cancellationto:

 Administrative SupportTeam

 Medicines and Healthcare products RegulatoryAgency (MHRA).

MHRAhas authority to cancel license of product if it affects public health.

 

ROW countries
 ROW countries means the rest of the world countries excluding

EU,US,JAPAN,CANADA ,AUSTRALIA,NEW ZEALAND,SOUTH AFRICA.
They come under the semi regulated market.

 Product registration in rest of world is a challenging task like regulated
countries (US, EU & Japan) as they are not harmonized. It creates a
difference in regulatory environment in Semi Regulated countries.

 Enormous diversity of regulatory requirements are found in this area. This
region consists of mainly the countries from Asia pacific, Latin America,
Eastern Europe, Africa and Gulf countries.

 Intensity of audits/ inspections are different and similarly penalties for
GMP violations are different.

 

 Asia-Sri Lanka, India, Bangladesh,;ASEAN: 10 Countries group –
Philippines, Vietnam Singapore, Malaysia, Thailand, Indonesia, Laos,
Cambodia, Brunei Darussalam, Myanmar

 African countries-Algeria, Zambia, Ethiopia, Ghana, Kenya, Malawi,
Mozambique, Namibia, Nigeria, Sierra Leone, Tanzania, Zimbabwe
etc

Middle East countries-Gulf Co-operation Council countries i.e.
Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, UAE

 Latin America-Mexico, Brazil, Panama, Peru, Guatemala, Argentina,
Chile, Dominican Republic

 CIS (common wealth of independent states): Russia, Ukraine,
OFSUs-Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan,
Kirghizstan, Moldova, Tajikistan, Turkmenistan, Uzbekistan etc.

 

Registration Requirements for Rest of
the World

 Administrative Documents:-

1. Certificate of Pharmaceutical Product

2. Product Permission

3. Manufacturing License

4. WHO-GMP Certificate

5. Free Sale Certificate/Export Certificate

6. Artwork (Carton, Label & Package Leaflet)

7. Chemistry, Manufacturing & control documents

 

DMF- DRUG MASTER FILE

 API DMF Open part – Following data should be available in Open Part

1. Nomenclature

2. General Properties

3. Name of the Manufacturer and Site of manufacture

4. Route of Synthesis, flow diagram in brief

5. Structural Elucidation

6. Impurities

7. Specifications and Method of Analysis

8. Container Closure System

9. Stability testing – Retest period & Storage

10. API Specification and Method of Analysis & COA of API by the Applicant

 

Manufacturing Formula & Process

 Manufacturing Formula

 Description of manufacturing/packaging

 Scale, Equipment by type, capacity, process parameters for steps (e.g. time, temp,
pH), Environmental conditions, e.g. Relative Humidity for Hygroscopic materials

 Description of In process controls/test

 Flow Diagram- Indicate critical steps , In-process controls

 Master formula

 Batch manufacturing Record – Copy of the Master BMR or Completed BMR

 Process Validation Protocols and /or reports-3 batches process validation reports
and /or protocol is to be submitted. 3 Batches should be of the same size and
should be similar to the batch size mentioned above in the manufacturing formula.

 Formulation & Development is required for some countries like Russia, Ukraine,
Algeria, Kenya, ASEAN etc.

 Batch Analysis – Results of at least one batch should be given. It should be
preferably of the batch of which the samples will be submitted for registration. OR It
can be of the latest batch, as required by the agency in the respective country. It
should be given as certificate of analysis.

 

 

 

 

Emerging Markets: Key Challenges
 Lack of harmonization in regulatory requirements:

 Absent, new or changing regulations

 Lack of quality manufacturing capacity and differences in Labeling

 Emerging market health authorities have limited resources

 Lack of effective legislation to allow use of so-called ‘TRIPs flexibilities’ such as compulsory
licensing.

 They require local patients in clinical trials/ B.E study to participate. Patient may/may not
participate in Phase I

 Lack of adequate human resources and funding for drug regulatory activities.

 Lack of adequate regulatory science capacity to assess generic products that potentially meet
the need for essential drugs.

 Lack of formal pre-submission meetings or scientific advice.

 Long review timelines for registration hence more uncertainty.

 More detailed documentation, SOPs, validation requests

 More requests for inspections, (Lack of mutual recognition of ICH countries and amongst
countries within region)

 

STRUCTURE OF CTD

 

REGULATORY
PROCESS
FILLING

 

THERAPEUTIC GOODS ADMINISTRATION

 TGA is unit of the Australian government department of health , is a regulatory
body of for therapeutic goods in Australia

 The objective of therapeutic goods act 1989 which came into affect on 15
February 1991 is to provide a national framework , responsible for conducting
assessment and monitoring activities to ensure that therapeutic goods
available in Australia are of an acceptable standard to ensure the quality ,
safety, and efficacy of medicines and performance of medical devices .

 

Medicine or food ?

 Products for oral consumption are either regulated as either foods or therapeutic
goods. If there is no prescribed standard in the Food Standard Code or no tradition
of use as a food the goods are most likely not food.

 Products which may fit within the definition of either a food or a medicine are
referred to a joint TGA/food standard Australia new Zealand committee , ERPIM (
external reference panel or interface matters) which recommends whether the
goods should be regulated as a therapeutic good or as food.

 The presentation of the a product can help to determine whether it will be treated as
food of a medicine . e.g. clove of garlic is food. However if it is concentrated and
marketed in capsule form with claims that it can be used to relieve clove and flu
symptoms it will be treated as a medicine

Medicine or cosmetic?

 Depends on the claim it depicts

 E.g. moisturizer which contains a sunscreening agent as a secondary component
and have a stated therapeutic purpose are medicines

 Even if product is intended for marketing as a cosmetic it may be classified as a
medicine depending on its ingredient route of administration , or if therapeutic
claims are made on its label or in advertising.,

 

Role of TGA

 The TGA carries out a range of assessment and monitoring activities to
ensure that all therapeutic goods available in Australia are of an
acceptable standard. It aims to ensure that the Australian community has
access within a reasonable time to therapeutic advances

 The overall control of medicines is exerted through 5 main processes
1. Pre market evaluation and approval of registered products intended for

supply in Australia
2. Development , maintenance , and monitoring of the systems for listing of

medicines,
3. Licensing of manufacturers in accordance with international standard of

GMP
4. Post marketing monitoring , through sampling , adverse event reporting,

surveillance activities, and response to public inquiries,
5. The assessment of medicines for export.

 

What makes the goods therapeutic?

Therapeutic goods are broadly defined as products for use
in humans in connection with:
preventing, diagnosing, curing or alleviating a disease,

ailment, defect or injury
Influencing, inhibiting or modifying a physiological

process
testing the susceptibility of person to a disease or ailment
influencing, controlling or preventing conception
testing for pregnancy
Replacement or modification of parts of the anatomy.

 

ELEMENTS TO REGULATE

 Auditing and assessment of the quality of their manufacture – Act requires
each Australian manufacturer of medicinal products for human use to hold a
manufacturing license.

 Pre market assessment of goods – includes study of toxicity and dosage form
of medicines. The product risk is determined by side effects, inappropriate self
medication , adverse affects for prolonged use.

 Post market regulatory authority – compliance with standard once the goods
are supplied on the market , monitoring of adverse reactions , targeted and
random surveillance in market place.

 

Therapeutics goods act 1989

 The act sets out the legal requirements for the import , export , manufacture
and supply of medicines in Australia. It details for listing or registering all
medicines in the Australian register of therapeutic goods as well as many
other aspects of the law including advertising, labelling and product
appearance.

Role of sponsor
The sponsor of a medicine is a person or the company who is responsible for
applying to the TGA to have their medicine included in the ARTG.

Under the act the role of a sponsor is someone who:-

 Imports therapeutic goods

Manufacture therapeutic goods

 Has therapeutic good imported or manufactured on their behalf

 Exports there peptics goods from Australia.

 

AUSTRALIAN REGISTER OF THERAPEUTIC GOODS
 The ARTG is establishes under part 3 of act. Essentially the therapeutic

goods must be entered in the Australian register of therapeutic goods
(ARTG) before they can be applied in Australia. It is a computer database
of information about therapeutic goods for human use approved for supply
in or exported from Australia.

 In consultation with industry , TGA has developed the Australian
Regulatory Guidelines for the complementary medicines (ARGCM) to
assist sponsors of complementary medicines to meet their legislative
obligations.

 Australian manufacturers of all medicines must be licensed under part 4 of
therapeutic goods act 1989 and their manufacturing process must comply
with the principles of GMP.

Once approved for marketing in Australia , medicines are included in the
ARTG and can be identified by AUST R ( registered medicines ) and
AUST L ( listed medicines) that appears on the packaging of the
medicines.

 

 Listed medicine – are considered to be of lower risk then registered
medicines. The regulations allow the sponsor to self assess their
products in some situations. The majority of such medicines are used for
self assessment and treatment.

 They are assessed by the TGA for quality and safety but not efficacy ,
which implies that TGA has not evaluated them individually .

Medicines which are for export are listed in the ARTG. Most
complimentary medicines come under listed category.

 Registered medicine – are medicines having a higher risk . The degree
of assessment and regulation they undergo is rigorous and detailed, with
sponsor being required to provide comprehensive safety , quality ,
efficacy data.

 High risk registered –usually available on prescription e.g. all injectables

 Low risk registered – are available without prescription. E.g. mild
analgesics, cold/cough preparations, anti fungal creams etc.

 

SUMMARY AND CONCLUSION
 Any export market demands good quality dossier which can be generated through

systematic Formulation Development.

 The proper planning and execution of Formulation development will help in quality dossier
& in answering queries from Regulatory authorities.

 Since the world is divided in the drug approval procedures with technical data as described
above, it is important especially for the generic manufacturers, to carefully judge the market
need, Development Cost, target regions, & regulatory requirements before the
development of drugs.

 Hence it is critical to plan and co-ordinate all the activities for successful launch of product
in the market on time.

 Due to vast difference in Regulatory requirements it is impractical to get global marketing
approval at same time and launch the product at once in all regions.

 Hence, one should carefully understand and define the clear regulatory strategy by looking
at the target regions, different patent terms and its extension, various application
possibilities, data requirements, potential timeline for marketing launch in different regions.
This eliminates unnecessary studies, minimizes the delay in drug approvals and
subsequent launch, and reduces overall cost of development.

 

REFERENCES
1. http://www.ema.europa.eu/docs/en_GB/document_library/Leaflet/2014/08/WC5001716

74.pdf

2. http://www.ich.org/fileadmin/Public_Web_Site/Training/ASEAN_Q5C_workshop_May_201
1/ASEAN_Intro_ICH_GCG.pdf

3. http://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.375.519&rep=rep1&type=pdf

4. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/
WC500004011.pdf

5. http://www.ema.europa.eu/docs/en_GB/document_library/Presentation/2016/02/WC50
0201043.pdf

6. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3555014/

7. VEMURI PAVAN KUMAR , N VISHAL GUPTA , A REVIEW ON DRUG APPROVAL IN REGULATED
AND NON REGULATED MARKET,INTERNAQTIONAL JOURNAL OF PHARMACEUTICAL
SCIENCES,

8. https://www.gov.uk/government/organisations/medicines-and-healthcare-products-
regulatory-agency

9. https://regulatoryaffairsblog.wordpress.com/2013/04/02/rest-of-the-world-row-regulatory-
authorities/

10.https://www.tga.gov.au/