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HARMONIZATION OF GMP INSPECTION IN THE EAST AFRICAN COMMUNITY WHO Technical Briefing Seminar

HARMONIZATION OF GMP INSPECTION IN THE EAST AFRICAN COMMUNITY WHO Technical Briefing Seminar 5 th November 2014 Presented by: Kate Kikule (Mrs.) Technical Officer (Rotational) World Health Organization Geneva, Switzerland. Presentation Outline.

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HARMONIZATION OF GMP INSPECTION IN THE EAST AFRICAN COMMUNITY WHO Technical Briefing Seminar

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  1. HARMONIZATION OF GMP INSPECTION IN THE EAST AFRICAN COMMUNITY WHO Technical Briefing Seminar 5th November 2014 Presented by: Kate Kikule (Mrs.) Technical Officer (Rotational) World Health Organization Geneva, Switzerland

  2. Presentation Outline • Facts about EAC • Background to medicine regulation harmonization in EAC • EAC GMP TWG • Achievements • Challenges • Plan for the future

  3. EAST AFRICAN COMMUNITY

  4. EAC Quick Facts

  5. Background to Harmonization in the EAC

  6. Background II • Setback to the 2006-2008 Action plan • Slow progress of implementation • Inadequate funding of TWGs • However, the consortium of WHO, NEPAD, DFID and GTZ, expressed their interest in supporting RECs, (Johannesburg, Feb 2009) and called for funding proposals from RECs

  7. EAC Medicine Regulation harmonization project • Funded by Bill and Melinda Gates Foundation • Duration – 5 years • Four(4) regional technical working groups were established • Medicine registration – Tanzania • Good Manufacturing Practice Inspection – Uganda • Information Management Systems – Rwanda • Quality Management Systems - Kenya

  8. EAC GMP TWG Composition • The technical working group 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)

  9. Aim of the harmonization initiative • Harmonized legal framework for GMP, guidelines and procedures for GMP Inspection • Development of medicine regulatory curricula and training materials, including e-learning • Improved regulatory systems for faster access of quality medicines on to the EAC market

  10. Achievements: Guidance Documents developed and approved for use within the EAC • Manual for Good Manufacturing Practice Inspection • Guidelines for: • GMP of medicinal products and related annexes • preparation of site master file for pharmaceutical manufacturing facilities • Training and Qualifications of GMP Inspectors • Standard Operating Procedures for: • planning for GMP inspections • preparing for a GMP inspection • conducting a GMP inspection • preparing and reviewing a good manufacturing practice inspection report • follow up on non-compliances after GMP inspection • Joint GMP inspections

  11. Achievements II Under the WHO PQ-EAC Inspection Collaboration Procedure with EAC NMRAs: exchange of information including inspection schedules through a secure website WHO support to training of GMP Inspectors through training courses Inspectors from EAC Partner States NMRAs have participated in joint inspections as either observers or co-inspectors 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 Partner States NMRAs are inspecting facilities within their countries

  12. TFDA NDA ZFDA KPPB RWANDA

  13. 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 levels of medicine regulation and as a result moving at the same speed is still a challenge

  14. Plan for the future Plan for July 2014 to June 2015: Continue with joint inspections among member states twinning among the member states develop formal training program for GMP Participate in development of a legal framework for GMP Continuous, regular joint inspections with other international bodies, programs like the WHO pre-qualification program and other well resourced NMRAs Common database and a platform for sharing information which will guide regulatory decisions

  15. Thank you for listening kikulek@who.int katkikul@gmail.com

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