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Doktorantenkolloquium im Rahmen der Dissertation im Fachbereich Drug Regulatory Affairs an der Uni Bonn am 04.04.2008
Topics
General requirements for a new marketing authorization application Special requirements per region (EU / USA / Non-ICH selected countries) Conclusion
04.04.2008
Andrea Hrner
Non-ICH countries covers all countries outside ICH includes also Canada, Switzerland & Australia The ICH countries developed a common format for submissions of new marketing authorization applications (MAAs) CTD format
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Andrea Hrner
04.04.2008
Andrea Hrner
Topics
General requirements for a new marketing authorization application Special requirements per region (EU / USA / Non-ICH selected countries) Conclusion
04.04.2008
Andrea Hrner
Module 1 according to European legislation 1.2 Application form 1.3 Summary of product characteristics, labelling and package leaflet 1.4 Information about the experts 1.5 Specific requirements for different types of applications 1.6 Environmental Risk Assessment 1.7 Information relating to orphan market exclusivity 1.8 Description of the Pharmacovigilance System 1.9 Risk Management Plan
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Phase III clinical studies requested to get an approval without Phase III data no approval can be obtained! Administrative documents, e.g.
CPP GMP certificates Letter of authorizations (Power of Attorneys) Labeling documents CoAs of Drug Substance (DS) and Drug Product (DP)
Stability requirements different from ICH, valid for NCEs (not for NBEs):
Long term testing:
Products packed in semi-permeable containers: 30C 2C / 75% RH 5% RH mind. 12 months 30C +/- 2C, humidity not specified (for products in impermeable containers), 12 mo
Accelerated studies: 40C 2C / 75% RH 5% RH min. 6 months Stress studies: 40C 2C / 75% RH 5% RH
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Batch Records requested for DP (!) Detailed information about quality part requested, even very confidential information
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Andrea Hrner
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Topics
General requirements for a new marketing authorization application Special requirements per region (EU / USA / Non-ICH selected countries) Conclusion
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Andrea Hrner
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Conclusion
ICH CTD dossier is the basis for new MAAs worldwide Module 2 to 5 can be used in general for global submissions For some countries it might be advisable to submit not the whole CTD dossier due to confidentiality reasons documents with non confidential (abbreviated) content can be prepared Each country has additionally special requirements which needs to be considered before submission of MAAs to the authority otherwise a rejection of the application or a deficiency letter may be obtained Be proactive Talk to the agencies as a partner
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Back Up
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Topics
Legal background List of abbreviations
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Andrea Hrner
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Legal background
European Union (EU):
Directive 2001/83/EEC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use COMMISSION DIRECTIVE 2003/63/EC of 25 June 2003 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use Directive 2004/27 EEC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use Andrea Hrner 23
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Legal background
EU (cont):
Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency
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Legal background
EU (cont):
Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use Notice to applicants
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Legal background
USA
CFR Title 21 - Food and Drugs CHAPTER I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)
Part 310 New drugs Part 312 Investigational new drug application (INDA) Part 314 Applications for FDA approval to market a new drug PART 316 Orphan drugs PART 600 Biological products - General
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Legal background
CADREAC:
Procedure on the granting of MAs by CADREAC Drug Regulatory Authorities for human medicinal products already authorized in EU member states following the decentralized procedure Procedure on the granting of MAs by CADREAC Drug Regulatory Authorities for medicinal products for human use authorized in the EU following the centralized procedure and the variation and renewal of such marketing authorizations
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Legal background
CADREAC (cont):
Guidance for simplified procedure for MA of medicinal products authorized in the European Union following the Centralized procedure and for variations and renewals to these MAs in CADREAC area Common CADREAC Procedure (CCP) for retrospective inclusion of centrally authorized MPs for human use in the Common CADREAC Simplified System - in force since May 2001
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Legal background
Brazil: Resolution stability Brazil_RDC137 2003-05-29 Brazil_RDC140 2003-05-29 Brazil_RDC1548 2003-09-23 Brazilian Guideline on new biological entities (NBEs) RDC 136.03 (registro medicamentos novos)
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Legal background
Singapore (ASEAN):
Guidance on Medicinal Product Registration in Singapore Guidance For Drug Registration In Singapore_Effective1Nov2004 Guidelines for the conduct of Bioavailability and Bioequivalence Studies DR Guide main for circulation (041206)
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Legal background
Singapore (ASEAN) (cont):
Appendix 4 - Application checklist (ACTD & ICH CTD) Appendix 6A - Singapore Quality Overall Summary for Chemical Drugs Appendix 6B - Singapore Quality Overall Summary for Biologics Appendix 8 - Guideline on Submission Requirements for Non-Prescription Medicines
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Legal background
Taiwan:
New Chemical Entity (NCE) GuidelineChap 1-13 (revised) gNDA CDE draft 07-29-05 (English) Stability guideline Register of NDA dossier The revised draft of the Guidance on the Preparation of Plant Master File (PMF)
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Legal background
China:
DRUG REGISTRATION REGULATION (SFDA Order 28) with the 6 annexes:
Annex 1: Registration Categories and Application Information Requirements of TCM and Natural Drugs Annex 2: Registration Categories and Application Information Requirements of Chemical Drugs Annex 3: Registration Categories and Application Information Items Requirements of Biological Products Annex 4: Registration Items and Application Information Requirements of Supplemental Application of Drug Registration Annex 5: Application Information Items of Drug ReRegistration Annex 6: Timeframe for monitoring period of New Drugs (notes, no note: no monitoring period will be established for the drugs other than those listed) (table 1-3)
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Topics
Legal background List of abbreviations
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Andrea Hrner
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