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First Joint Product Assessment Experience from EAC Partner States

Hiiti SilloAg. Director General

Tanzania Food and Drugs Authority (TFDA)

14th ICDRA, 28th Nov – 3rd Dec 2010

Singapore

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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

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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

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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 1967EAC dissolved 1977EAC re-established July 7, 2000Rwanda and Burundi became members of the EAC

July 1, 2007

Main languages: English, Kiswahili, French5/31/2011 4

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LOCATION MAP OF EAST AFRICAN

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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

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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

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EAC Medicines Registration Harmonization -Progress

• Kampala, December 2005– Prepared Action Plan for medicines harmonization in the

EAC• January 2006 - 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

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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

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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

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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

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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)

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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

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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 2010

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WHO/EAC Pilot Joint Evaluation – March, May, July & Nov 2010, Copenhagen

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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)

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Lessons learned (2)• Trust building among regulatory staff of EAC

Partner States– Facilitate implementation of planned MRH Project

2011-2015– 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

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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

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Recommendations to 14th 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

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Thank you

Contacts:Hiiti B. SilloAg. Director GeneralTanzania Food and Drugs AuthorityTel:+255 22 2450751Fax: +255 22 2450793Email: hiiti.sillo@tfda.or.tz/hiiti@yahoo.comWebsite: www.tfda.or.tz

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