INDIA CHINA and SOUTH AFRICA

1. MARKET
AUTHORISATION
CHECKLIST FOR BRICS
SUBMITTED BY,
JAYA PRAKASH V,
REG NO --218311,
REGULATORY AFFAIRS.

2. INTRODUCTION
• BRICS comprises the developing markets of Brazil, Russia,
India, China and South Africa.
• These countries are all deemed to be at a similar stage of
newly advanced economic development.
• It is typically rendered as "the BRICS" or "the BRICS
economies“

3. Reasons for the emergence of BRICS market:
• Decline in the growth rate of the developed pharmaceutical market
in developed nations.
• Decline in R & D productivity.
• Availability of patient population in emerging markets.
• R & D resources availability.
• Changing regulatory and investment environment for the research.

4. • Marketing authorization (MA) is a Process of reviewing and
assessing the dossier to support a medicinal product which is
approved by the regulatory authority of a country.
• Marketing Authorization, which has been issued by regulatory
authority for a product, allows the holder to sale the product in the
market.
• Medicines meeting the standards of Safety, Quality and Efficacy are
granted “Marketing Authorization” in order to be prescribed or sold.

5. INDIA: Central Drug Standard Control
Organization (CDSCO)
S.N DOCUMENTS TO BE SUBMITTED YES/NO
1. Covering letter
2. Name of applicant
3. Application form in Form 44
4. Name of the drug
5. Treasury challan
6. Composition of new drug
7. Information on active ingredients

6. S.N DOCUMENTS TO BE SUBMITTED YES/NO
8 Physiochemical data
9 Analytical data
10 Validations – assay methods, impurity profile
11 Stabilities studies
12 Data on formulation
13 Animal Pharmacology
14 Clinical pharmacology
15 Proposed indication for drug

7. S.N DOCUMENTS TO BE SUBMITTED YES/NO
16. Carcinogenicity
17. Special studies
18. Free sale certificate
19. Inspection/audit report
20. Draft specimen of the label
21. Wholesale license
22. Declaration of conformity
23. Regulatory status in other countries

8. CHINA: State Food and Drug
Administration (SFDA)
S.N DOCUMENTS TO BE SUBMITTED Yes/No
1 Authorization letter to the China Registration Agent for
Chinese Product Standard Drafting
2 Application form
3 Certificate of Quality Management System
4 Certificate of pharmaceutical product (CPP)
5 Certificate of analysis
6 Legal registration of the company

9. S.N DOCUMENTS TO BE SUBMITTED Yes/No
7 SOPs for test methods
8 Self-test reports
9 Approval of Clinical Study
10 Free sale certificate
11 Label information
12 Specifications, conformed standards and testing report
13 Clinical trial report
14 Other documents may required
15 GMP certificate

10. SOUTH AFRICA : MEDICINES CONTROL
COUNCIL
S.N DOCUMENTS TO BE SUBMITTED Yes/No
1 Letter of Authorization
2 Administrative information
3 Proof of payment
4 Product batch information
5 API change control
6 Patient Information Leaflet
7 List of countries

11. S.N DOCUMENTS TO BE SUBMITTED Yes/No
8 Amendments/Variations
9 Environmental Risk Assessment
10 Good manufacturing practice
11 Date of last inspection of each site
12 Inspection reports
13 Finished Product Release Control (FPRC) tests
14 Contract manufacturing if any
15 Sample and Documents
16 CoA of the samples

12. THANK YOU