FAPMA Federation of African Pharmaceutical Manufacturers Associations

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
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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
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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
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It takes political will
THANK YOU
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