Presentation on regulatory affairs 30032013
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This document discusses the requirements for regulatory submissions for marketing authorization in various countries and regions. It provides an overview of the key documents needed for marketing authorization in India, including application forms, manufacturing licenses, site documents, and product information. It also summarizes the common ICH CTD format used for submissions to countries like the EU, US, and Japan, as well as the ASEAN CTD format used in Southeast Asian countries. The ASEAN CTD and ICH CTD formats are compared, highlighting similarities and differences in their organization. Finally, specific documentation requirements are outlined for dossier submissions in countries like Myanmar, Vietnam, and Singapore, focusing on drug substance specifications, analytical methods, and
Presentation on regulatory affairs 30032013
- 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.guatda.com/cmx.p0...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/