14.04.2011

International Conference on Local Pharmaceutical Production in Africa

Quality Infrastructure and harmonization of medicines regulations

Margareth Ndomondo-Sigonda Pharmaceutical Coordinator AU NEPAD Agency

Presentation Outline • NEPAD Agency Mandate • African Medicines Regulatory Harmonization (AMRH) Programme • Key Features of medicines registration harmonization projects • The Role of SAGMA • Conclusions and Recommendations

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NEPAD Agency Mandate • New Partnership for Africa’s Development (NEPAD) Programme of the AU - 2001 • Updated mandate as NEPAD Planning and Coordinating Agency (NPCA), technical body of the AU– February 2010 • NPCA functions: • Facilitate and coordinate the implementation of the continental and regional priority programmes and projects; • Mobilize resources and partners in support of the implementation of Africa’s priority programmes and projects; • conduct and coordinate research and knowledge management; • Monitor and evaluate the implementation of programmes and projects; and • advocate on the AU and NEPAD vision, mission and core principles/values

NEPAD Agency… • Thematic Areas: – Agriculture and Food Security e.g implementation of the Comprehensive Africa Agricultural Development Programme (CAADP) – Climate Change and Natural Resources Management e.g Environment Action Plan (EAP) – Regional Integration and Infrastructure – Human Development i.e. education, health, science and technology

• Two important programmes for pharmaceutical sector development: – African Medicines Regulatory Harmonization (AMRH) – focus for presentation – Strengthening Pharmaceutical Innovation in Africa • Overall aim is to enhance access to essential, affordable medicines and vaccines, in particular through improved medicines registration and pharmaceutical innovation

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African Medicines Regulatory Harmonization (AMRH) Programme •

Emanate from the Pharmaceutical Manufacturing Plan for Africa (PMPA) following the endorsement by the 55th African Heads of State Assembly of 2005

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Some of the key elements of the PMPA include: – The need to have conducive legislative framework at national and regional extending beyond Good Manufacturing Practice (GMP) to include Good Distribution Practice (GDP), Good Laboratory Practice (GLP), Good clinical Practice (GCP) and other aspects of product regulation

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WHO-AFRO 56th Regional Committee Meeting, August 2006 emphasis on key elements for success in promotion of local pharmaceutical production: – Need for sound medicines regulatory systems in achieving local production policy priorities as key to assure the quality, safety and efficacy of locally manufactured products and their positive contribution to public health – the need for both strengthening and harmonising regulatory systems, in order to realize local production policy objectives as trade in pharmaceuticals is hampered by disparate regulatory systems, which create technical barriers to the free movement of products manufactured in Africa

African Medicines Regulatory Harmonization (AMRH) Programme • Aim(s) and Genesis: – Overall goal: to assist RECs in their endeavour to improve access to good quality, safe and essential medicines to address priority health problems in their respective member states through harmonization of medicines registration

– Phased Approach: Initial focus on registration of priority medicines such as malaria, TB and HIV medicines, with broader scope of products (vaccines) and regulatory functions (clinical trial regulatory oversight) over a long term – 2007 & 2008: High level decisions at Pan African Parliament (PAP) committees on Health and S&T in African Ministerial Conference on S&T – 2009: NEPAD Agency, PAP Secretariat and Partners consultation meeting with regional economic communities (RECs) and 40 National Medicines Regulatory Agencies (NMRAs) on value of medicines regulatory harmonization – 2009-2011: Medicine registration harmonization project proposal development for RECs; EAC, SADC, OCEAC/ECCAS, ECOWAS/UEMOA, AMU/CEN-SAD, IGAD

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AMRH … • Partnerships and Collaborations: – NEPAD Agency, AUC, PAP, WHO, BMGF, DFID, CHAI, WB, UNAIDS

• Strength: niche roles • Key areas of work: – – – – – – –

Political advocacy, Resource mobilisation (financial and in-kind), RECs MRH project development, Monitoring and evaluation of implementation by RECs and NMRAS, Stakeholders engagement: industry, SRAs, donors, PDPs e.t.c, Development and implementation of technical standards, Coordination of collaborating partners

Key Features of RECs medicines registration harmonization (MRH) Projects • Development and implementation of common registration requirements and standards based on CTD format – Development of harmonised guidelines and CTDs, – Joint assessment of dossiers, – Joint GMP inspections

• To build regional and national capacity to implement medicines registration harmonization in the – Institutional, human and infrastructural capacity built – Training programmes and Work sharing – Establishment of regional centres of regulatory excellence

• Institutionalization of quality management and information management systems – Encourage NMRAs to review business processes and systems – More efficient and effective delivery of services – Cost effective use of resources

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Key Features - RECs MRH Projects… • To develop and implement a framework for mutual recognition based on regional protocols and/or treaties • Establishment of effective coordination mechanism at national and regional levels – Steering Committee composed of Heads of NMRAs to oversee implementation – Institutionalisation of a Results based framework for M&E

• To create a platform for information sharing on the harmonised medicines registration system to key Stakeholders at national and regional level – Engagement of the national and regional association of pharmaceutical industry in the MRH process

The Role of SAGMA • •

Key role of pharmaceutical industry in shaping medicines policies and regulations world wide Industry response on NEPAD commissioned Situation Analysis in SADC region – Received 8 filled questionnaires from 14 member states excluding Madagascar • DRC, Lesotho, Malawi, Mozambique, Seychelles, South Africa, Zambia, Zimbabwe • SAGMA recognition as a regional body: DRC, Zambia, Zimbabwe, South Africa!

– Challenge: to get proper and genuine representation of industry views at country level • South Africa: PIASA, IMSA, NAPM, SMASA, PHARMISA • Seychelles: No pharmaceutical manufacturing company

– Generally, harmonization process accepted widely with varying degree of confidence levels • 1* is facilitation of access to wider market • Increase patient access to quality and safe medicines

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The Role of SAGMA… • Industry Response… • Fear small developing economies to be marginalised by bigger economies • Fear by bigger economies that the process will undermine their local industry • Fear of elevation of standards hence exclusion from market • Lack of political will in some countries • Frustration by some that the process takes too long and industry excluded • Apparent lack of will by some NMRAs – loss of Authority

The Role of SAGMA… • Industry Response… • Vision of industry – Proposed staggered approach to assist some countries to set up competent NMRAs while existing ones to set the harmonization ball rolling with others joining later – Some view harmonization as providing pathway to mutual while others don’t – Some view harmonisation as a long term process with initial focus on labelling requirements, scheduling and classification system

• Meeting planned on 2nd May, in Lilongwe-Malawi to engage the industry in the region • SAGMA to assist in collating industry views fro the region

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CONCLUSIONS & RECOMMENDATIONS


Strengthening and harmonising medicines regulation is a critical factor for promotion of local production of pharmaceuticals in Africa




Need establishment of appropriate governance structures for effective coordination and political advocacy of pharmaceutical programmes at national, regional and continental levels

3. Need for establishment of pharmaceutical stakeholders forum at national, regional and continental levels composed of academia, researchers, NMRAs and industry Improving African peoples’ access to quality, efficacious and affordable medicines is everyone’s business; public and private sector collectively

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