1. WHO Technical Briefing Seminar
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
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2. Presentation Outline Facts about EAC
Background to medicine regulation harmonization in EAC
EAC GMP TWG
Achievements
Challenges
Plan for the future
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3. EAST AFRICAN COMMUNITY
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4. EAC Quick Facts Area (including water): 1.82 million km2 Population:
GDP (current market price):
$110.3 billion
EAC Headquarters:
Arusha, Tanzania
EAC first established
1967
EAC dissolved
1977
EAC re-established
July 7, 2000
Rwanda and Burundi became members of the EAC
July 1, 2007
Main languages:
English, Kiswahili, French
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5. Background to Harmonization in the EAC
Year
Activity
Outcome
1999
EAC Treaty
Cooperation among EAC States
2000
Directive of the EAC Council of Ministers
Research, Policy and Health Systems Working group tasked to draft common Drug Policy and Harmonized drug regulation procedures
2001
Meeting of Technical staff from NMRAs in EAC
Developed guidelines and application forms for registration of Veterinary Drugs
2005
EAC Customs Union
Common external tariffs on medicines
African Drug Regulators Conference, Addis Ababa
Recommendation to promote harmonization using existing RECs
Kampala meeting
Action plan for harmonization in the EAC
2006
Nairobi
Formation of TWGs
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6. Setback to the 2006-2008 Action plan Inadequate funding of TWGs
Background II
Setback to the 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
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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
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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)
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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
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10. Guidance Documents developed and approved for use within the EAC
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
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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
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12. TFDA
NDA
ZFDA
KPPB
RWANDA
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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
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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
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15. 1/25/2018

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