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Outline

Progress made on the development of CTD for registration of medicines for EAC Medicines Regulatory Harmonization Project Bujumbura, Burundi 2 nd – 3 rd September 2013. Outline. Background Composition of the TWG-MER Responsibility Progress Challenges Way forward Conclusion.

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Outline

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  1. Progress made on the development of CTD for registration of medicines for EAC Medicines Regulatory Harmonization Project Bujumbura, Burundi 2nd – 3rd September 2013

  2. Outline • Background • Composition of the TWG-MER • Responsibility • Progress • Challenges • Way forward • Conclusion

  3. Background • Chapter 21 (Article 118) of the EAC Treaty • Provides for harmonization of drug registration and regulation • Harmonize drug registration procedures • Harmonize national health policies and regulation and promote the exchange of information on health issues in order to achieve quality health within the Community.

  4. Harmonization of medicines registration procedures • Purpose: To harmonize medicines registration in the EAC Partner States in order to • increase the rapid availability of safe, efficacious and good quality essential medicines in the region • enable free movement of pharmaceuticals within the region to complement the implementation of the EAC Customs Union operational since 2010 • Goal: To have a harmonized and functioning medicines registration system within the East Africa Community in accordance with national and internationally recognized policies and standards i.e. WHO & ICH]

  5. Composition of TWG on Medicines Evaluation and Registration (MER) • Constituted by 12 members drawn from all the 6 EAC Partner States’ NMRAs. i.e. • Kenya Pharmacy and Poison Board (future KFDA) • National Drug Authority of Uganda • Tanzania Food and Drugs Authority (TFDA) – Lead country • Zanzibar Food and Drug Board (ZFDB) • Rwanda Pharmacy Task Force (now RFMA) • Directeur de la Pharmacie, du Médicament et des • Laboratoires (DPML) of Burundi (Future ABREMA)

  6. Responsibilities • To develop harmonized technical requirements and guidelines for registration of human medicines. • Develop EAC Common Technical Document (CTD) format for application for registration of human medicines in EAC. • Present the developed CTD, technical requirements and guidance for application for registration of medicines in EAC to the Steering Committee for approval.

  7. Responsibilities (cont) • Develop assessment guidelines and Standard Operating Procedures (SOPs) for assessment of medicines dossiers. • Identify and develop a list of vital essential and necessary (VEN) medicines that will be jointly assessed by EAC Partner States and present to the project Steering Committee for approval. • Facilitate domestication of the agreed technical document for registration of medicines, guidelines and SOPs for application and assessment of dossiers.

  8. Progress made – TWG on MER • Meetings held • Video conferences - between July 2012 and August 2013 • 3 face to face meetings- in July, October 2012 and May 2013 • Development of EAC – guidelines/documents

  9. Progress made (2) 1. EAC Guidelines on Submission of Application for registration of Medicines Common Technical Document (CTD) with appendixes – mother document • Provide guidance for applicants preparing a Common Technical Document for registration of medicines • Describes how to organise applications based on the International Conference on Harmonisation of Technical Requirements

  10. Progress made (3) The CTD consists of 5 modules: • Module 1: Prescribes Administrative Information and Prescribing Information requirements, • Module 2: Quality overall summary (QOS), • Module 3: Quality (API and FPP), • Module 4: Non-clinical, • Module 5: Clinical

  11. Progress made (4) • Annexes • Annex I – Covering letter. • Annex II – EAC application form • Annex III – Expert report. • Annex IV – Letter of access for DMF/CEP. • Annex V – Quality Overall Summary • Annex VI – Quality review requirements.

  12. Progress made (5) 2. Quality overall summary of module 2 and module 3: quality • Assist applicants on the preparation of the Quality Module for generic medicinal products • Provides clear general guidance on the format of presenting information • Provide guidance on the technical and other general data requirements.

  13. Progress made (6) Quality overall summary (QOS) • Overview of Module 3 • Emphasize critical key parameters of the product • Key issues that integrates information from sections in the Quality Module and supporting information from other Modules (e.g. qualification of impurities via toxicological studies).

  14. Progress made (7) Module 3: Main data on quality of API and FPP • API data submission Options 1: EAC-Active pharmaceutical ingredient master file (EAC-APIMF) or Option 2: Full details in the Marketing Application Dossier (MAD). • FPP – full documentation

  15. Progress made (8) 3 . Requirements for stability studies • Active pharmaceutical ingredient • Finished pharmaceutical ingredient • Address new and existing APIs/FPP • Not applicable for biologicals – vaccines • Stress stability • Regulatory stability – accelerated and long term • Long-term • 30 °C ± 2 °C/75% RH ± 5% RH • Accelerated • 40 °C ± 2 °C/75% RH ± 5% RH 6 months

  16. Stability studies • Approved by 2nd SC • Storage conditions requirements for FMPs intended for storage in a refrigerator • Long-term • 5 °C ± 3 °C 12 months • Accelerated • 25 °C ± 2 °C/60% RH ± 5% RH or • 30 °C ± 2 °C/65% RH ± 5% RH or • 30 °C ± 2 °C/75% RH ± 5% RH • FMPs intended for storage in a freezer • 5 °C± 3 °C or 25 °C ± 2 °C or 30 °C ± 2 °C)

  17. Therapeutic equivalence • Specify the requirements for the design, conduct, and evaluation of bioequivalence studies • Immediate release and modified release dosage forms with systemic action • Stipulates exemptions for carrying out in vivo bioequivalence (BE) • In vitro dissolution tests as a surrogate for in vivo BE studies • Other studies • Comparative pharmacodynamics studies • Comparative clinical studies

  18. Procedural aspects for applications • Outline procedures from submission of a dossier to the final outcome, timeframe and procedure for competent authorities to amend, where necessary the conditions of marketing authorization of a particular product. • Provide guidelines on general requirements – language, font size etc • Outline procedures for different types of applications; new, renewal & variation

  19. Guidelines completed and approved by SC • Guidelines on PIL (at 2nd SC) • Guidelines on SmPC (at 2nd SC) • Guidelines on labeling requirements (at 2nd SC)

  20. Completed guidelines ready for approval by SC (1) • EAC guidelines on submission of application for registration of human medicinal products (main guideline). • EAC guidelines on therapeutic equivalence requirements. • EAC guidelines on registration of fixed-dose combinations (FDCs • EAC guidelines on biowaiver • EAC list of standard terms for pharmaceutical dosage forms and routes of administration.

  21. Completed guidelines ready for approval by SC (2) • EAC guidelines on procedural aspects of application for registration of human medicinal products. • EAC guidelines on stability requirements. • EAC guidelines on labeling requirements. • EAC common glossary of terms used in medicines registration.

  22. Completed guidelines ready for approval by SC (3) • 10. Annexes to the EAC guidelines on submission of application for registration of human medicinal products (main guideline):- • Annex I – Covering letter. • Annex II – EAC application form for marketing authorization of medicinal product. • Annex III – Expert report. • Annex IV – Letter of access for DMF/CEP. • Annex V – Quality Overall Summary – Product dossier. • Annex VI – Quality review requirements.

  23. Work in progress • EAC guidelines on selection of comparator products • EAC guidelines on application for variation of a registered medicinal product. • EAC common assessment procedure. • Training modules on evaluation • EAC Active Pharmaceutical Ingredient (API) procedure • Guidelines on requirements for registration of biological/biotechnological products

  24. Challenges (1) • Lack of clear procedures for internationalization of the approved guidelines in Partner States regulatory systems • Few face to face meetings versus workload (development of documents) • Persistent non refunding money used by NMRAs for project activities under the virtual budget procedures

  25. Way forward • Capacity building activities planned/underway a) Twining programme (2nd quarter - 2013/14) b) Training on dossier assessment (3rd quarter ) c) Joint assessments (4th quarter) d) WHO/EAC joint assessment sessions (continuing) • Appointment of TWG members for replacement • More interactive sessions – face to face meetings at least 3 for this financial year

  26. Thank you very much

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