1. Critical and Comparative Analysis of Marketing
Authorization Procedures in Developing Countries &
Developed Countries
Submitted to:
College Mentor: Corporate Mentor:
Dr. Shibu John Mr. Srikant B
Head of Department Senior Manager (RA)
Jamia Hamdard TherDose Pharma Pvt Ltd.

2. • TherDose Pharma Private Ltd., is a Research
and Development company established in
December 2003 at Hyderabad, India.
• Build with a vision of creating technology
and therapeutic research based speciality
pharmaceutical company, with core
expertise in the area of dosage form design
and development

3. History
• TherDose Pharma Private Limited, a company incorporated as 100%
Export Oriented Unit incorporated in the year 2003.
• Founded by Dr. Nagesh Palepu, a US-Indian Citizen with Dr. Bulusu B
Teja, Managing Director.
• SciDose is US based company co-founded by Dr. Nagesh and Joseph
Bohan, in the year 2006.
• TherDose became subsidiary for SciDose in the year 2008.
• TherDose was initially a dedicated R&D Company and entered into
manufacturing, only, in the year 2012.

4. Products

5. Our Distribution Network

6. Objectives
Broad Objective
• To understand about international marketing in the pharmaceutical sector,
on how a manufacturer can start marketing its medicines in various
countries.
Specific Objectives
• To study about the procedures of Marketing Authorization in
developing and developed countries.
• To study on how a pharmaceutical company can start marketing of
medicines in various countries by following the guidelines and
protocols set up by their health regulatory body.

7. Research Methodology
Research Design
• An observational study was done in TherDose Pharma Pvt Ltd, Hyderabad
to study the marketing authorization procedures in developing and
developed countries.
• The main purpose of the study was to scrutinize the approvals which are
necessary to market a drug in different countries. The approval must be
granted so as to market a drug as well as to sell drugs. Without the
knowledge of marketing authorization procedure, marketing cannot be
followed.

8. Cont..
Data Collection
• Data collection was done in TherDose Pharma Pvt Ltd, Hyderabad in
the time period of June-July, 2015.
• Secondary data was studied and compiled. Journals, marketing & RA
research reports, dossiers of different countries and websites were
referred.
• Also, documents & certificates like IND form #44, WHO GMP
certificate, MAA of Kenya, MAA of Moldova and MAA of Philippines
was also studied to obtain necessary data for the study.

9. Cont..
Research Tools
• Mostly secondary data was collected, studied, analysed and
consolidated to form the report.
• For flow charts and diagrams, Gliffy and SmartDraw softwares were
used.
Method of Analysis
• Qualitative analysis of the gathered information was done which was
obtained mainly through secondary data.

10. Marketing Authorization
• Marketing Authorisation Application (MAA) is an application submitted by a
drug manufacturer to the regulatory bodies, seeking permission to bring a
developed medicinal product to the market.
• Marketing authorization applications can be classified broadly in three
groups, which comprise applications for:
1. Products containing new chemical or biological active pharmaceutical
ingredients (APIs);
2. Multisource pharmaceutical products (generic products);
3. Variations to existing marketing authorizations.

11. What does MAA consist of?
• MAA is a comprehensive dossier of information and data describing
all aspects (Administrative/Quality/Safety/Efficacy) of a medicinal
product demonstrating that it is appropriate for use in patients.
• There is an internationally agreed standard for the overall content
and format for this dossier which is referred to as the Common
Technical Document (CTD).

13. ICH
• ICH produces guidelines on data
requirements for MA of new chemical
entities and biologicals for use in the
member regions of ICH.
• ICH has developed over 50
harmonised guidelines aiming at
eliminating duplication in the
development and registration
process, so that a single set of studies
can be generated to demonstrate the
quality, safety and efficacy of a new
medicinal product.

14. Certificate of Pharmaceutical Product
(CPP/COPP)
• A CPP is a certificate issued by the national health authorities upon
request from either the manufacturer, the customer or the
authorities in the importing country.
• The certificate is issued for a specific product and states whether or
not the product is marketed in the country of origin.
• Furthermore, it states that the manufacturer of the product complies
with GMP and that they are inspected regularly by the national
health authorities.

15. CDSCO (Central Drug Standard Control
Organization)
• CDSCO is the national regulatory body for Indian pharmaceuticals
and medical devices, and serves parallel function to the European
Medicines Agency (EMA) of the European Union, the Pharmaceutical
and Medical Devices Agency (PDMA) of Japan and the Food and Drug
Administration (FDA) of the United States.
• Within the CDSCO, the Drug Controller General of India (DCGI)
regulates pharmaceutical and medical devices.

16. Variation in MA
• After a product has been authorized for marketing, the manufacturer
will often wish to make changes (variations) for a number of
reasons. The two common areas for change are
1. pharmaceutical aspects of the product (quality control,
manufacturing, shelf-life, etc.) or
2. Product information (post marketing findings)

17. MA in Developed Countries
• Developing countries comes under the Regulatory Market. The
following countries are known as Regulatory Market.
1. EU
2. USA
3. Canada
4. Japan
• All these developed countries follow ICH guidelines while marketing
and as well as in creating dossier.

18. MA Procedure in EU
• The EMA and the authorisation procedure
In 1993 the European Medicines Agency (EMA) was founded with the
primary task of providing scientific advice of the highest possible
quality to the Community Institutions on all matters relating to
medicinal products for human and veterinary use.
• EMA's main task is to co-ordinate the scientific evaluation of the safety,
efficacy and quality of medicinal products which undergo either
procedure.
• The European system offers three routes for the authorisation of medicinal
products:
1. The Centralised procedure
2. The Decentralized procedure
3. The Mutual Recognition procedure

19. The Centralised Procedure

20. The Decentralized Procedure

21. The Mutual Recognition procedure

22. MA Procedure in USA
• The regulatory body is USFDA.
• MAA is accomplished in two
phases:
1. Clinical Trials
2. NDA
• Takes about 180 days to grant
MAA approval.

23. MA Procedure in Canada
In Canada, the MA
comes under NDS i.e.
New Drug Submission
Takes about 210 days to
approve MAA.

24. MA Procedure in JAPAN
• Pharmaceutical and
Medical Devices Agency
(PMDA)
• The PMDA provides
consultation concerning
clinical trials of new drugs
and conducts approval
reviews of a NDA as well as
for ANDA
• Takes about 180 days to
approve MAA.

25. MA in Developing Countries
• The countries who follow ICH guidelines are also known as Regulatory
Countries while countries that do not follow ICH guidelines are known as
ROW market.
• ROW market is further divided into the following markets:
1. LATAM (Latin America)
2. ASEAN (Association of South East Asian Nations)
3. Africa
4. CIS (Commonwealth of Independent States)
5. India

26. Overview of ICH – CTD and ACTD
Dossier ICH – CTD ACTD
Administrative
Documents &
Product
Information
Module 1 Part I
CTD Overview
and Summaries
Module 2 Incorporated in
part II
Quality
Documents
Module 3 Part II
Non-Clinical
Documents
Module 4 Part III
Clinical
Documents
Module 5 Part IV

27. MA Procedure in LATAM Countries
BRAZIL
• The federal regulatory agency responsible for pharmaceutical product
registration in Brazil is ANVISA (Agência Nacional de Vigilância
Sanitária/National Sanitary Vigilance agency), which was established
in 1999.
• Takes about 180 days to approve MAA.

28. Application
Submission
Pre-filling
Screening
Review
Review by
ANVISA
Regulatory
Decision by
ANVISA
Approval

29. MA Procedure in ASEAN COUNTRIES
Association of South–East
Asian Nations (ASEAN)
follows ASEAN – CTD
(ACTD). ASEAN is a geo-
political and economic
organization of ten countries
located in Southeast Asia as
shown in Figure.

30. MA
Procedure in
Philippines
Application Submission
Application Screening by FDA
Application Evaluation
Decision by FDA
Approval/Rejection

31. COUNTRY REGULATORY BODY TIME LINE FEES
Singapore HAS (Health Sciences
Authority)
90-240 working days 2,750 USD
Malaysia NPCB (National
Pharmaceutical Control
Bureau)
80-210 working days 670 USD (1 API) &
920 USD (2 or more API)
Philippines FDA 6 months 300 USD (Branded) &
220 USD (Generic)
Myanmar FDA 1 year 400 USD
Thailand TFDA (Thailand Food and
Drug Administration)
70-110 working days 65 USD
Cambodia Department of Drugs &
Food
1 year 300 USD (1 API) &
500 USD (2 or more API)
Indonesia NADFC (National Agency for
Drug and Food Control)
100-150 working days 650 USD
Vietnam MOH (Ministry Of Health) 1 year 210 USD

32. MA Procedure in CIS Countries
The Commonwealth of Independent
States (CIS) is a regional organisation
whose participating countries are former
Soviet Republics, formed during the
breakup of the Soviet Union.
At its conception it consisted of 12
former Soviet Republics: Armenia,
Belarus, Kazakhstan, Kyrgyzstan,
Moldova, Russia, Tajikistan,
Turkmenistan, Ukraine, and Uzbekistan,
Azerbaijan, Georgia.

33. MA in Russia
• The regulatory processes in CIS
countries are led and supervised
by Regulatory Agency,
Roszdravnadzor closely
collaborating with or operating
within the respective Ministries
of Health.
• Takes about 120 days to approve
MAA.
• MA procedure has three stages.

34. MA in MOLDOVA
• Marketing authorization procedure in Moldova is same as in
Russia. The regulatory body in Moldova is AM (Agentia
Medicamentului), rest all the procedures are same.
• Takes about 160 days to approve MAA.

35. MA Procedure in India
NDA in India
• The NDA registration (using form # 44 along with full pre-clinical and
clinical testing information) is applied after the completion of clinical
trials.
• The information regarding the prescription, samples and testing
protocols, product monograph, labels, and cartons must also be
submitted.
• Takes about 160 days to approve MAA.

36. NDA Approval
Process

37. Conclusion
• The Pharmaceutical market based on the diversity in the regulation
region and marketing interest can be divided into two groups:
Regulatory and ROW markets.
• The regulated market involves those countries where there are
defined regulatory requirements set by the regulatory bodies of that
country and the emerging market countries are those who still lag
behind in putting forward the well-defined regulations for drugs.
• The drug approval process comprised mainly the two steps:
1. application to conduct clinical trial and
2. application to the regulatory authority for marketing
authorization of drug.

38. Cont
• As every country has its own Drug Regulatory Authorities, which is
responsible to enforce the rules and regulations and issue the
guidelines to regulate the marketing of a drug.
• Therefore, it is very difficult, especially for the companies with
global approach to develop one single regulatory approach for a
Marketing Authorization Application (MAA) for a new drug on the
basis of one dossier submitted simultaneously to different countries
in the world.

39. Country Regulatory body Time for Regulatory
Approval of
CTA/IND
Application
Time for Evaluation of
MAA
MAA Fee
EU EMA 120 day 210 days $192,400
USA USFDA 30 days 180 days $217,787
Canada Health Canada 35 days 210 days £254100
Japan PMDA 80 days 160-180 days 11000HKD
Brazil ANVISA 90 days 180 days 37'000 BRL
Russia Roszdravnadzor 30-40 days 120 days $50,000
Moldova AM 30-40 days 160 days $45,000
India CDSCO 30 days 150 days 50,000 INR

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p and mid .

42. WHO GMP Certificate
OF TherDose Pharma

43. MAA OF KENYA

44. MAA OF MOLDOVA

45. MAA OF PHILIPPINES

47. Any Questions?