Presented by Mr. Apollo MuhairweRegistrar, National Drug Authority of Uganda
ICDRA Meeting, Singapore, 28th November 2010
EAC PARTNER STATES’ MEDICINES REGISTRATION HARMONIZATION INITIATIVE
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EAC Quick Facts
Area (including water): 1.82 million km2
Population: 133.5 million (June 2010)
GDP (current market price): $74.5 billion (2009)
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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EAC Summit
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Background to Harmonization in the EACYear 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
2005 African Drug Regulators Conference, Addis Ababa
Recommendation to promote harmonization using existing RECs
2005 Kampala meeting Action plan for harmonization in the EAC
2006 Nairobi Formation of TWGs5/27/2011 4
WHO SUPPORT TO HARMONIZATION OF MEDICINE REGULATION IN AFRICA
DATE AND PLACE
NATURE OF MEETING OUTCOMES
2005Addis Ethiopia
1st African Meeting Regulatory Conference
•Implementation Plans 2006‐2007 (Both Franco‐phone and Anglo‐phone)•Strategic Plan 2006 ‐ 2010
April 2007 GenevaSwitzerland
Start‐up meeting for model medicines regulatory package
7 representative countries in Africa were selected•Agreed on format and content of the WHO model technical package•Agreed on working methods and procedures•Agreed on membership and TORs of the national working groups
April 2008Geneva Switzerland
Consolidation meeting on the WHO model registration package
•Feedback of assessment using WHO prequalification criteria•Feedback was obtained from the 7 pilot countries namely; Kenya, South Africa, Ghana, Tanzania, Uganda and Zimbabwe. EMA provided Model assessment while DNDi provided ACT product for assessment5/27/2011 5
June 2008Johannesburg South Africa
Consolidation meeting attended by 18 African Countries
Unpackaging/introducing model regulatory package
August 2009 Visit by EAC Consultancy team to assess readiness of NMRAs in member states
Situational Analysis of NMRAs I EAC member states
November 2009Maputo Mozambique
2nd African Conference of medicines Regulatory Agencies
Resolved to support medicine registration harmonization utilizing RECs
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Kampala Meeting Action Plan
Function/Activity Time frame Responsibility
Shared Website August 2006 WHO
Use of the shared website August 2006 MRAs, EAC
Format for Guidelines on Technical Requirements
September 2006 Tanzania
Appointment of members of TWGs
September 2006 Heads of MRAs
Recruit Pharmaceutical Focal Person at EAC Secretariat
September 2006 WHO/EAC
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Technical Working Groups (TWGs)
TWG name Activities/Functions Lead country
Administrative aspects Autonomous DRA, Code of conduct, medicines schedules, registration (administrative part), registration software
Tanzania
Quality QC Labs, registration (quality part), counterfeits, product recalls
Uganda
Safety and efficacy Clinical trials, Pharmacovigilance, registration (safety and efficacy part)
Uganda
GMP issues GMP Uganda
Veterinary Registration of veterinary drugs Tanzania
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Setbacks to the 2006‐2008 Action Plan
• The absence of a focal person at EAC• Slow progress of implementation• Shared website not yet active• Inadequate funding of TWGs• However, the consortium of BMGF, DFID, GTZ, NEPADand WHO expressed their interest in supportingRECs, (Johannesburg, Feb 2009) and called forfunding proposals from RECs
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EAC DRH: Objectives• Implement a CTD• Implement a common management information system
• Streamline processes and implement quality management system in each NMRA
• Make NMRA information available to the public• Establish framework for joint assessments and inspections
• Build technical, financial and management capacity for drug registration harmonization and establish EACMFSC
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Proposed Structure of the EAC DRH Project Management
Secretary General
Deputy Secretary General
Director Social Sectors
Senior Health Officer M&FS
Senior Health Officer Medicines Regulation
Office Management Assistant
E‐Health & Informatics Officer
Accountant
NMRA Focal Persons
6 NMRA Task Forces
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EAC drug registration harmonization project highlights
Activity Target year
To launch a regional drug registration website to by December 2010
December 2010
To implement a CTD for registration and common GMP inspection guidelines
December 2011
To fast track the registration of essential medicines using risk‐based approaches
December 2011
To establish systems for joint evaluations and inspections
December 2010
To establish the East African Community Medicines and Food Safety Commission
January 2010
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DRH Activities undertaken by Uganda
Activity Time
Capacity building for assessors at WHO Prequalification of Medicines Program
2001 to date
WHO/EAC Joint Pilot Assessment 2010
Situational analysis of counterfeit medicines in East Africa
2008 to date
Training programs: Drug Registration, GMP, Pharmacovigilance, GLP, Clinical Trials
2008 to date
Afro Vaccines Regulators’ Forum (AVAREF) 2005 to date
Global Training Network on Vaccines Quality
2005 to date
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WHO/EAC Pilot Joint Evaluation – March, May, July & Nov 2010, Copenhagen
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ASANTE SANA
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