1. PRESENTATION TO THE NATIONAL STAKEHOLDERS MEETING OF THE EAC REGIONAL STEERING COMMITTEE BY THE GMP TWG Presented by: Uganda, Kenya, United Republic of Tanzania, Rwanda, Burundi

2. Outline Terms of Reference GMP TWG Objectives Composition Achievements Plan for the period Challenges

3. Terms of Reference Harmonized legal framework for GMP Harmonized guidelines for GMP Harmonized procedures, report format and templates for GMP Harmonized GMP aide memoire/checklist Harmonized procedure for planning, organizing, conducting and monitoring joint GMP inspections Curricula and training materials, including e-learning Harmonized procedure for qualification of GMP inspectors Exchange of information on GMP inspections Research on current best practices in the field of regulatory inspections Coordinate consultative meetings with all stakeholders

4. Objectives of establishing EAC GMP Two regional centres of excellence in training on assessor and GMP inspector established in the EAC region by end of year five (5) of the project Twenty five (25) EAC and NMRA MRH project staff trained on project management by end of year five (5) Twenty four (24) assessor trained in assessment of quality, safety and efficacy of medicines by the end of year five (5) Twenty four (24) inspectors trained on GMP inspection by end of year five (5)

5. Composition The technical working group is chaired by the Re public of Uganda(Chair) Is composed of twelve members drawn from the six NMRAs of the Republics of Burundi, Kenya, Rwanda, Uganda and The United Republic of Tanzania (Mainland) and Tanzania (Zanzibar)

6. Achievements  14 video conferences  3 face-to-face meetings - Kampala - Kigali - Bujumbura

7. Achievements: Documents developed and which Project Steering Council approval Inspection Manual for Good Manufacturing Practice Guidelines for GMP of medicinal products and related annexes Guidelines on preparation of site master file for pharmaceutical manufacturing facilities Guidelines on Training and Qualifications of GMP Inspectors SOP for planning for GMP inspections. SOP for preparing for a GMP inspection. SOP for conducting a GMP inspection SOP for preparing and reviewing a current good manufacturing practice inspection report SOP for follow up on none compliances after GMP inspection SOP for joint inspections Questionnaire for assessment of Trainee Inspectors

8. Achievements Under the WHO PQ-EAC Inspection Collaboration Procedure, NMRAs and WHO-PQ have continued to exchange inspection schedules through a secure website and inspectors from EAC Partner States NMRAs have participated in joint inspections as co-inspectors Uganda, Kenya, United Republic of Tanzania, Rwanda, Burundi

9. Achievements  Inspectors have used the prequalification program as a platform for capacity building at international level through participation in inspections as observers  Inspectors from different NMRAs have participated in joint inspections within the region when other inspectors from States Partners NMRAs are inspecting facilities within their countries

10. 10 TFDA NDA ZFDA KPPB RWANDA

11. Challenges  Lack of mutually recognized legal frame work encompassing all the Partner States reduces the speed at which the TWGs are moving. Each Partner State has its own laws and regulations that are independent  All the Partner States NMRAs are at a different level of medicine regulation and as a result moving at the as speed is still a challenge Uganda, Kenya, United Republic of Tanzania, Rwanda, Burundi

12. Request to the National Stakeholders Inspection Manual for Good Manufacturing Practice Guidelines for GMP of medicinal products and related annexes Guidelines on preparation of site master file for pharmaceutical manufacturing facilities Guidelines on Training and Qualifications of GMP Inspectors SOP for planning for GMP inspections. SOP for preparing for a GMP inspection. SOP for conducting a GMP inspection SOP for preparing and reviewing a current good manufacturing practice inspection report SOP for follow up on none compliances after GMP inspection SOP for joint inspections 12

13. Way forward Way forward  Plan for July 2013 to June 2014 has been developed  Continuous, regular joint inspections with other international bodies, programs like the WHO pre- qualification program and other well resourced NMRAs is one of the methods the region will build capacity through a hands on approach  Common database and a platform for sharing information which will guide regulatory decisions Uganda, Kenya, United Republic of Tanzania, Rwanda, Burundi

15. Thank you for listening Uganda, Kenya, United Republic of Tanzania, Rwanda, Burundi