Objective: Access to medicines has long been and remains a challenge in
African countries. The impact of medicines registration policies in these
countries poses a challenge for pharmaceutical companies wanting to register
medicines in these countries. The recent AMRHI (African Medicines Registration
Harmonisation Initiative) has increased the focus on the need for harmonisation.
Medicines registration regulations differ across African countries. Anecdotal
evidence, based on the experience of pharmaceutical companies on progress
towards harmonisation is somewhat different, i.e. that country specific
requirements were a barrier to the registration of medicines. The objective of
this study was therefore to determine the nature and extent of regulatory
hurdles experienced by pharmaceutical companies who wish to register and supply
medicines to African countries.
Methods: This cross-sectional descriptive pilot study was conducted across
pharmaceutical companies, both local and multinational. These companies were
based in South Africa and were also members of Pharmaceutical Industry
Association of South Africa (PIASA). The pharmaceutical companies supply both
the private and public sectors. An online survey was developed using Survey
Monkey. Survey questions focused on the following strands: nature and level of
current supply of medicines to African countries by companies, general
regulatory requirements, region specific questions and country specific
questions across four regional economic communities in Africa, namely; Southern
African Development Community (SADC), East African Community (EAC), Economic
Community of the West African States (ECOWAS) and Economic Community of Central
African States (ECCAS).
Results: A total of 33 responses were received to the questionnaire of which
26 respondents were from the PIASA Regulatory working group and 7 were from the
PIASA Export working group.It was noted that since most of the regulatory
authorities in Africa are resource-constrained, harmonisation of medicine
registration policies will contribute positively to ensuring the safety, quality
and efficacy of medicines. The experience of pharmaceutical companies indicated
that country specific regulatory requirements are a barrier to registering and
supplying medicines to African countries. In particular, GMP inspections, GMP
inspection fees and country specific labeling were cited as key problems.
Conclusion: Pharmaceutical companies operating in African markets are
experiencing difficulties in complying with the technical requirements of
individual African countries. Further research is required to provide a balanced
perspective on the country specific regulatory requirements vs. the African
Regulatory Harmonisation Initiative (AMRHI).