Invited lecture by Institute of Research & Development, Gujarat Forensic Science University and Lab.

1. Regulatory Affairs
Dr. Nishodh Saxena
30th March 2013

2. Data in the dossier should enable us to answer
the following questions
 What is the product?
 Is the quality presented acceptable on grounds of safety and
efficacy?
 Is the quality presented reproducible?
 How long can the quality be maintained?
Quality must ensure consistency of safety and efficacy during the shelf life of all
batches produced

3. Requirements of Documents for Marketing Authorization in INDIA
1. Duly filled and signed form as per the requirement.
2. Copy of the challan of Fee paid.
3. Land possession document.
4. List of Directors
5. Memorandum of article of association
6. Authority letter for authorized signatury.
7. Copy of the form 46 (approval of CT)
8. Copy of the approved plant layout.
9. Site Master File
10. Copy of NOC of Pollution control board.
11. Water system P & I diagram.
12. HVAC details and Area qualification report.
13. Process flow chart
14. List of SOPs
15. Specification
16. Copy of approval and contract of Waste disposal.

4. Requirements of Documents for Marketing Authorization in INDIA
17. List of equipments for Manufacturing.
18. List of equipments for Quality Control.
19. List of Products in 6 copies.
20. Draft Label.
21. List of Technical Staff.
22. Any other document as required. e.g. Inspection report,
Compliance report, Check compliance report, CoAs, Undertaking
etc.

5. Commonly used forms as per D & C Act 1940
1. Form 24 Application for products of C, C (1) and X
2. Form 25 License C, C (1) and X
3. Form 27 Application for products excluding C, C (1) and X
4. Form 28 License for products excluding C, C (1) and X
5. Form 29 License for purpose of examination, test or analysis.
6. Form 30 Application for purpose of examination, test or analysis.
7. Form 35 Inspection book.
8. Form 46 Permission/approval for manufacture of New Drug
Formulation.

6. Track sheet for the documents required for filling and approvals.
1. Product-Brand
2. Product-Generic
3. Npd Form for the country
4. IDR Proof
5. DCI-Domestic
6. NOC-Export
7. Mfg. Lic.
8. COPP
9. BMR
10. BPR
11. RM Spec/STP
12. FP Spec/STP
13. PM Spec/STP
14. RM COA
15. FP COA
16. API COA

7. Track sheet for the documents required for filling and approvals.
17. AMV-FP
18. PVP/PVR
19. Stability Acc Study data
20. Stability Real Time Study data
21. BE/BA or CT Report
22. FP Samples
23. API Open Part DMF
24. FP Chromatogram
25. API Chromatogram
26. Working Standard
27. Literature

8. ICH / Non-ICH countries
 International Conference of Harmonization (ICH)
• European Union
• USA
• Japan
 The ICH countries developed a common format for submissions of
new marketing authorization applications (MAAs) CTD format
 Non-ICH countries covers all countries outside ICH includes also
Canada, Switzerland, Australia and ASEAN

9. ASEAN: Association of South-East Asian Nations
Population: 500 millions
Member countries (10)

10. Common Wealth if Independent States (CIS countries)
Member countries (11+1)
1 Russia
2. Ukrain
3. Kazakhastan
4. Belarus (Head Quarter)
5. Uzbekistan
6. Turmenistan (associate member)
7. Azerbaijan
8. Georgia
9. Armenia
10. Kyrgyzstan
11. Tajakistan
12. Moldova

11. RoW (Rest of the World)
RoW is Rest of the World excluding
UK, USA, Other Euro American Countries (OEAC) including
Australia, New Zealand & Canada

12. General requirements for marketing authorization application for
Biosimilars –ICH-CTD
ICH-CTD Dossier
 Complete ICH CTD dossier requested for ICH countries and some Non- ICH
countries (like Canada, Switzerland, Australia, Croatia)
Organization of ICH-CTD
 ICH-CTD dossier (Module 1, 2, 3 4, and 5)
 Module 1: Administrative documents Labeling texts and mock-ups
 Module 2: Overviews and Summaries
 Module 3: Quality Data
 Module 4: Preclinical Data
 Module 5: Clinical Data

13. ASEAN: Association of South-East Asian Nations/ non-ICH countries
A-CTD Dossier
For Market Authorization in ASEAN, Dossier is filed mainly in A-CTD format
Organization of A-CTD
 A-CTD dossier (Part I, II, III and IV)
 Part I : Administrative Information
 Part II :Quality Document
 Part III :Preclinical / Safety Document
 Part IV : Clinical / Efficacy Document

14. ASEAN: Status of ACTD Implementation
For ASEAN countries the ASEAN CTD has become mandatory from 2009 onwards!

15. ASEAN: Association of South-East Asian Nations
Organization of A-CTD ASEAN-CTD and ICH-CTD
Main differences are the organization of data and the numbering of sections

16. Organization of A-CTD ASEAN-CTD and ICH-CTD
ASEAN-CTD ICH-CTD
Part II Module 2
Quality Summary Quality Overall Summary
& Module 3
Body of Data Quality
Quality Part contains all the data related to Drug Substance (DS) and Drug
Product (DP) with complete details but basic contents remains the same for
both

17. ICH-CTD Module 3
Module 3
3.1 MODULE 3 TABLE OF CONTENTS
3.2 BODY OF DATA
3.2.S DRUG SUBSTANCE
3.2.S.1 General Information
3.2.S.2 Manufacture Module 3 (Cont.)
3.2.S.3 Characterisation 3.2.A APPENDICES
3.2.S.4 Control of Drug Substance 3.2.A.1 Facilities and Equipment
3.2.S.5 Reference Standards or Materials 3.2.A.2 Adventitious Agents Safety Evaluation
3.2.S.6 Container Closure System 3.2.A.3 Novel Excipients
3.2.S.7 Stability 3.2.R REGIONAL INFORMATION
3.2.P DRUG PRODUCT 3.3 LITERATURE REFERENCES
3.2.P.1 Description and Composition of the Drug
Product
3.2.P.2 Pharmaceutical Development
3.2.P.3 Manufacture
3.2.P.4 Control of Excipients
3.2.P.5 Control of Drug Product
3.2.P.6 Reference Standards or Materials
3.2.P.7 Container Closure System
3.2.P.8 Stability

18. A-CTD Part II Section C (DRUG SUBSTANCE)
Section C: Body of Data S 5 Reference Standards or Materials
S DRUG SUBSTANCE S 6 Container Closure System
S 1 General Information S 7 Stability
S 1.1 Nomenclature Stability Summary and Conclusion
S 1.2 Structural formula Post-approval Stability Protocol and Stability
S 1.3 General Properties Commitment
S 2 Manufacture Stability Data
S 2.1 Manufacturer(s)
S 2.2 Description of Manufacturing Process and Process Controls
S 2.3 Control of Materials
S 2.4 Controls of Critical Steps and Intermediates
S 2.5 Process Validation and/or Evaluation
S 2.6 Manufacturing Process Development
S 3 Characterization
S 3.1 Elucidation of Structure and Characteristic
S 3.2 Impurities
S 4 Control of Drug Substance
S 4.1 Specification
S 4.2 Analytical Procedures
S 4.3 Validation of Analytical Procedures
S 4.4 Batch Analyses
S 4.5 Justification of Specification

19. A-CTD Part II Section C (DRUG PRODUCT)
P DRUG PRODUCT P 5 Control of Finished Product.
P 1 Description and Composition P 5.1 Specification
P 2 Pharmaceutical Development P 5.2 Analytical Procedures.
P 2.1 Information on Development Studies P 5.3 Validation of Analytical Procedures
P 2.2 Component of Drug Product P 5.4 Batch analyses
P 2.2.1 Active Ingredients P 5.5 Characterization of Impurities
P 2.2.2 Excipients P 5.6 Justification of Specification
P 2.3 Finished Product P 6 Reference Standards or Materials
P 2.3.1 Formulation Development P 7 Container closure system
P 2.3.2 Overages P 8 Product Stability.
P 2.3.3 Physicochemical and Biological Properties Stability Summary and Conclusion
P 2.4 Manufacturing Process Development Post-approval stability protocol and stability
P 2.5 Container Closure System commitment
P 2.6 Microbiological Attributes Stability Data
P 2.7 Compatibility P 9 Product Interchangeability
P 3 Manufacture
P 3.1 Batch Formula Section D: Key Literature References
P 3.2 Manufacturing Process and Process Control
P 3.3 Controls of Critical Steps and Intermediates
P 3.4 Process Validation and/or Evaluation
P 4 Control of Excipients
P 4.1 Specification
P 4.2 Analytical Procedures
P 4.3. Excipients of Human and Animal Origin
P 4.4 Novel Excipients

20. Data required for Dossier filing of Drug Substance (DS) in Myanmar/ Vietnam
• API specification as per EP
• STP of DS as per specification
For Dossier filing in Myanmar only Drug Substance Specification and Analytical
Procedures are required, Method Validation is not required

21. Additional documents required by the Regulatory agency for Dossier
Filing In Singapore (ASEAN)
􀂄 Special documents requested:
 Appendix 8: Singapore Quality Overall Summary for Biologic
 Validation sheet
 Singapore Stability sheet
 Administrative documents, e.g.
􀂄 CPP
􀂄 GMP certificates
􀂄 Letter of authorizations (Power of Attorneys)
􀂄 Labeling documents
􀂄 EU approval letters
􀂄 EU Assessment Reports (from benchmarking countries)
􀂄 TGA approval letters, if available
􀂄 Patent declaration form
􀂄 COAs of DS and DP

22. Additional documents required by the Regulatory agency for Dossier
Filing In Taiwan (ASEAN)
􀂄 Plant Master File registration required before MAA can be submitted
􀂄 Administrative documents, e.g.
􀂄 CPP
􀂄 GMP certificates
􀂄 Letter of authorizations (Power of Attorneys)
􀂄 Labeling documents
􀂄 COAs of DS and DP
􀂄 Batch Records requested for DP
􀂄 Detailed information about quality part requested, even very
confidential information

23. Additional documents required by the Regulatory agency for Dossier
Filing In China (ASEAN)
􀂄 Detailed information about quality part requested, even very confidential
information
􀂄 Administrative documents, e.g.
􀂄 Application Forms
􀂄 CPP
􀂄 GMP certificates
􀂄 Letter of authorizations (Power of Attorneys)
􀂄 Labeling documents
􀂄 SOPs for test methods
􀂄 COAs of DS and DP
􀂄 Only one manufacturer can be registered for DS and DP

24. Important web sites
DCGI-CDSCO : http://www.cdsco.nic.in/
DCGI Guidelines : http://www.google.com/#hl=en&sclient=psy-
ab&q=dcgi+guidelines+pdf&oq=DCGI+&gs_l=hp.1.3.0l4.258.6177.6.9734.9.5.4.0.0.0.118.561.0j5.
5.0...0.0...1c.1.7.psy-
ab.3rAuntWOcwU&pbx=1&bav=on.2,or.r_qf.&bvm=bv.44442042,d.bmk&fp=670e618efc243f0d&b
iw=1280&bih=923
e.g.
cdsco.nic.in/CDSCO-GuidanceForIndustry.pdf
www.cdsco.nic.in/Guidance_for_New_Drug_Approval-23.07.2011
WHO : http://www.who.int/en/
ICH : www.ich.org/
US-FDA : www.fda.gov/
CHMP : www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/...jsp
MHRA : www.mhra.gov.uk/ (Medicines and Healthcare products Regulatory Agency)
EMA : www.ema.europa.eu/
TGA : www.tga.gov.au/ ( Therapeutic Goods Administration, Australia's)

25. Thanks
Contact details:
Phone: 9824443676
Mail ID: nishodhsaxena@yaho.com
Profile: in.linkedin.com/in/drnishodhsaxena/