First Joint Product Assessment Experience from EAC Partner States

Transcription

1 First Joint Product Assessment Experience from EAC Partner States Hiiti Sillo Ag. Director General Tanzania Food and Drugs Authority (TFDA) 14 th ICDRA, 28 th Nov 3 rd Dec 2010 Singapore 1

2 Outline Background information The East African Community (EAC) EAC Regional Cooperation on Health EAC Medicines Registration Harmonization Project WHO-EAC Joint Pilot Project on product assessment Objectives Project Implementation & lessons learned Conclusions & Recommendations 2

3 The East African Community (EAC) A regional grouping of 5 Partner States Burundi Kenya Rwanda Tanzania Uganda 6 National Medicines Regulatory Authorities Including the Zanzibar Food and Drugs Board Preventable communicable diseases are responsible for the highest morbidity and mortality

4 EAC Quick Facts Area (including water): 1.82 million km 2 Population: million (June 2010) GDP (current market price): $74.5 billion (2009) EAC Headquarters: EAC first established 1967 EAC dissolved 1977 Arusha, Tanzania EAC re-established July 7, 2000 Rwanda and Burundi became members of the EAC Main languages: July 1, 2007 English, Kiswahili, French 5/31/2011 4

5 LOCATION MAP OF EAST AFRICA N

6 EAC Regional Cooperation on Health Chapter 21 (Article 118) of the EAC Treaty on Health Provides for harmonization of drug registration and regulation Harmonize drug registration procedures To achieve good control of pharmaceutical standards without impeding or obstructing the movement of pharmaceutical products within the Community; Harmonize national health policies and regulation and promote the exchange of information on health issues in order to achieve quality health within the Community

7 EAC Regional Cooperation on Health (2) Directive of the EAC Council of Ministers, 2000 Research, Policy and Health Systems Working Group Tasked to draft Common Drug Policy and Harmonized Drug Regulation Procedures Guidelines and application forms for registration of Veterinary Drugs, Dar es Salaam, 2001 EAC Customs Union, January 2005 Common external tariffs on medicines African Drug Regulators Conference, Addis Ababa November, 2005 Recommendation to promote harmonization through existing RECs e.g. EAC, SADC, ECOWAS/WAHO

8 EAC Medicines Registration Harmonization - Progress Kampala, December 2005 Prepared Action Plan for medicines harmonization in the EAC January December 2008 However, plan was not executed no Focal Person at EAC Secretariat, lack of funds, e.tc. Nairobi, August 2006 Formed 5 TWGs- Admin, Quality, GMP, Safety & Efficacy and veterinary medicines Geneva, January 2009 NMRAs agreed to revitalize TWGs and WHO committed support in preparing proposal for funding of harmonization activities

9 EAC Medicines Registration Harmonization (2) Johannesburg, RSA, Feb 2009 Workshop on harmonizing drug registration in Africa BMGF, DFID, GTZ, NEPAD and WHO confirmed their interest in supporting RECs Called for summary project proposals EAC summary project proposal on Medicines Registration Harmonization (MRH) written by May 2009 Expanded project proposal written in September 2009, and reviewed May June, 2010 WHO and NEPAD provided technical support 5 year project proposal submitted to donor agencies

10 EAC MRH Project The purpose of the EAC MRH Project To harmonize medicines registration in the EAC Partner States to increase the rapid availability of quality and safe essential medicines within the EAC region Enable the free movement of goods within the EAC Common Market operational from July 2010 Prioritization of the EAC MRH Project activities Based on a detailed situational analysis of all the 6 NMRAs conducted in August 2009

11 Key milestones of the EAC MRH project An agreed common technical document for registration of medicines implemented in at least three EAC Partner States A common integrated IMS established and linked in all EAC Partner States and EAC Secretariat Quality management system implemented in each of the EAC Partner States' NMRAs Regional and national capacity built to implement medicines registration harmonization in the EAC Platform for information sharing on the harmonised medicines registration system to key stakeholders at national and regional level created A framework for mutual recognition of regulatory decisions made by other EAC Partner States NMRAs developed and implemented

12 WHO-EAC Joint Pilot Project Joint pilot project is based on the objectives of the MRH Project and WHO work in the region WHO supported EAC in capacity building of regulatory staff since 2002 Assessment of medicines quality, safety and efficacy GMP inspections based on WHO Guidelines Participation in WHO Prequalification of Medicines Programme (WHO - PQP) since 2003 Assessment of dossiers submitted to WHO-PQP GMP inspection in observers capacity 3 months Rotational post at WHO HQ ( 6 fellows:1 Kenya, 2 Uganda, 3 Tanzania) 12

13 WHO EAC Joint Pilot Project (2) The pilot project was launched in March 2010 WHO asked EAC NMRAs to express interest to participate Two products were involved Abacavir (as sulphate) 60mg tablets for oral suspension Amikacin 500mg/2ml injection solution Applications simultaneously submitted to WHO PQ and EAC NMRAs Assessments conducted in Copenhagen Using WHO PQ Programe expertise to provide direct support to EAC assessors

14 WHO EAC Joint Pilot Project (3) 3 EAC Partner States fully participated in all assessment sessions Kenya, Tanzania and Uganda 6 EAC assessors were involved along with WHO- PQP assessors 2 from each NMRAs of participating countries Four (4) joint WHO/EAC assessment sessions conducted March, May, July and November

15 WHO/EAC Pilot Joint Evaluation March, May, July & Nov 2010, Copenhagen 5/31/

16 Lessons learned from the Joint Pilot Project Harmonization in practical terms Assessment skills are passed to less experienced assessors by working together Abacavir (as sulphate) dispersible tablets already prequalified by WHO Simultaneously registered in Kenya, Tanzania and Uganda Timely access to essential medicines» Product approved within 7 months (March to Sept 2010) Amikacin is very close to prequalification What would have been the situation in the absence of this arrangement? Delays in approval up to 24 months (past experience) 16

17 Lessons learned (2) Trust building among regulatory staff of EAC Partner States Facilitate implementation of planned MRH Project Will facilitate development of common requirements and working procedures for registration of medicines in EAC Platform for mutual recognition of regulatory decisions in the future Confidence in the work they do and network with other regulators through WHO-PQP 17

18 Conclusions The EAC/ WHO pilot project on joint assessments Seems very useful in capacity building Sharing limited human resources Speeding up of entry into the market of essential medicines to all EAC Partner States access to medicines is not hindered by unjustified regulatory work Perfect model for EAC MRH initiative 18

19 Recommendations to 14 th ICDRA Joint assessments be extended for another one year to bring on board assessors from Rwanda, Burundi and Zanzibar The model be extended to joint GMP inspections among EAC Partner States WHO should consider replicating the model to other regional economic communities (RECs) in Africa e.g. SADC, ECOWAS 19

20 Thank you Contacts: Hiiti B. Sillo Ag. Director General Tanzania Food and Drugs Authority Tel: Fax: Website: 20