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 1/25/2018

Presentation Outline Facts about EAC Background to medicine regulation harmonization in EAC EAC GMP TWG Achievements Challenges Plan for the future 1/25/2018

EAST AFRICAN COMMUNITY 1/25/2018

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 1/25/2018

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 1/25/2018

Setback to the 2006-2008 Action plan Inadequate funding of TWGs 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 1/25/2018

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 1/25/2018

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) 1/25/2018

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 1/25/2018

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 1/25/2018

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 1/25/2018

TFDA NDA ZFDA KPPB RWANDA 1/25/2018

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 1/25/2018

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 1/25/2018

1/25/2018

Thank you for listening kikulek@who.int katkikul@gmail.com 1/25/2018