Federation of African Pharmaceutical Manufacturers Associations FAPMA Dr Paul Lartey, Chair FEDERATION OF AFRICAN PHARMACEUTICAL MANUFACTURERS ASSOCIATIONS WAPMA Member Organizations: • Federation of East African Pharmaceutical Manufacturers FAPMA • Southern African Generic Medicines Association • West African Pharmaceutical Manufacturers Association 2 FAPMA OBJECTIVES Facilitate economic growth through development of a sustainable, selfsufficient and viable pharmaceutical industry in Africa Promote excellence, facilitate networking, disseminate information and raise awareness on matters relating to the pharmaceutical industry Promote access to safe, quality, efficacious medicines in Africa 3 FAPMA MEMBERSHIP Cote d’Ivoire DR Congo Ghana Kenya Lesotho • Critical mass of 231 manufacturers Malawi • Multiple technologies Nigeria • Potential to meet most of Africa’s needs South Africa Swaziland for generic medicines Tanzania Uganda Zambia Zimbabwe 4 COMMON ASPIRATIONS Availability of medicines • Quality • Safety • Efficacy People do what you inspect: Not what you expect – Edwards Deming The eye sees not itself but by reflection – William Shakespeare 5 COMMON THREATS • Proliferation of fake, counterfeit and sub-standard medicines in Africa - Challenges to regulation - Threat to the local industry • Image issues – Perception: - Regulators as non-stringent - Industry as non-GMP compliant 6 PMPA AS RALLYING POINT Pharmaceutical Manufacturing Plan for Africa • Strengthening of regulatory systems - Legislative framework Organizational development plans Partnership and support of AMRH • Growth of the industry - Quality systems Technology Human resources 7 CALL FOR COOPERATION AND SUPPORT Competent regulatory departments in the industry - Adequate staffing - Continuously trained regulatory scientists Road maps for mutual development - GMP - Regulatory Regional Medicines Regulatory Authorities - Standards and certification - Regional market approval 8 It takes political will THANK YOU