Presentation by medicines registration harmonisation in the SADC made at the Euro-Africa Health Investment Conference, March 26 - 27, 2013, London, United Kingdom.

1. SADC MEDICINES REGISTRATION
HARMONIZATION PROPOSAL
Euro-Africa Health Investment
Conference
March 26 – 27, 2013

2. OUTLINE
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BRIEF HISTORY
OBJECTIVES OF REGISTRATION HARMONISATION
BENEFITS OF REGISTRATION HARMONISATION
CHALLENGES

3. BRIEF HISTORY
• SADC Health Protocol for Regional
Cooperation and Integration
• Protocol Implementation Plan
• Priority areas: TB, Malaria and HIV/AIDS
• Program on Pharmaceuticals: regulation,
availability and access.
• AMRH(African
Medicines
Regulatory
Harmonisation) Proposal drafted in May 2011.

4. OBJECTIVES
• To develop and implement harmonised guidelines
for registration of medicines in SADC region
• To develop regional and national capacity to
implement medicines regulatory harmonisation
• To develop and implement national and regional
management information systems (MIS)
• To develop and implement a Quality Management
System (QMS)
• To create a platform for engaging key stakeholders
on the harmonisation of medicines registration
 Project has 5-year plan

5. Benefits of Medicines Registration
Harmonisation
• Improved access to safe, affordable, quality
essential medicines in SADC region
• Improved regulatory capacity and capability of
Medicines Regulatory Authorities (NMRAs) in
region
• Information and work sharing facilitates faster
decision making among NMRAs
• Facilitates access to regional markets for
manufacturers and suppliers

6. CHALLENGES
• NMRAs status at different levels of
development
• Lack of enabling legislation both national and
regional levels
• Shortage of Technical regulatory expertise
• Shortage of resources including training
facilities
• Lack of information and work sharing among
NRAs.
• Need for political and financial support

7. CHALLENGES
• NMRAs status at different levels of
development
• Lack of enabling legislation both national and
regional levels
• Shortage of Technical regulatory expertise
• Shortage of resources including training
facilities
• Lack of information and work sharing among
NRAs.
• Need for political and financial support