1. …………………Country National Stakeholders Consultation Meeting dd/mm/yy
Development of CTD for registration of medicines for EAC Medicines Regulatory Harmonization Programme
…………………Country National Stakeholders Consultation Meeting dd/mm/yy

2. Outline Progress Background Composition of the TWG-MER Responsibility
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 (future RFMA)
Department 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
23 Video conferences - between July 2012 and August
3 face to face meetings- in July, October 2012 and May 2013
Drafting and 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
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. Completed guidelines ready for approval by National Stakeholders (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.

20. Completed guidelines ready for approval by National Stakeholders (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.

21. Completed guidelines ready for approved by National Stakeholders (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.

22. Request to the National Stakeholders
To consider and approve the developed draft documents as listed above, and which have already been approved by the project’s regional steering committee, for further approval processes
Also
-To continue supporting the national and regional initiatives and efforts that are towards the improvement of peoples lives
-To continue participating in the approval processes that will follow at the regional level
Build more consensus and advocacy for strengthening the existing national Medicines Regulatory Agencies

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
procedures for internationalization of the approved guidelines in Partner States regulatory systems is not yet in place
Few face to face meetings versus workload (development of documents)
All the 6 NMRAs involved in the project activitie are not at the same level and more funds than budgeted will be required to build capicities in Rwanda, Burundi and United Republic of Tanzania (ZFDB)

25. Way forward Capacity building activities planned/underway
a) Twining programme (2nd quarter /14)
b) Training on dossier assessment (3rd quarter )
c) Joint assessments (4th quarter)
d) WHO/EAC joint assessment sessions (July and Sept 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