Biomedical Research in Developing Countries - UNICRI

committees or scientific advisory committees from Botswana, Burkina Faso,
Cameroon, Ethiopia, Gabon, Gambia, Ghana, Kenya, Malawi, Mali, Mozambique,
Nigeria, Rwanda, Senegal, Tanzania, Uganda, Zambia and Zimbabwe. Participating
countries are target for clinical trials of priority vaccines such as HIV/AIDS,
Malaria, Meningitis and Rotavirus. Experts from United States Food and Drug
Administration (USFDA) and European Medicines Evaluation Agency (EMEA) took
part in the meeting as well as cooperating partners such as the Program for
Appropriate Technology for Health (PATH) and European and Developing Countries
Clinical Trial Partnership (EDCPT). The new regulatory challenges posed by the
USFDA regulation, that does not oblige manufacturers to submit the Investigational
New Drug (IND) application for exports products and the recent change in the EU
regulation (726/2004) that does not request licence for products used exclusively
outside the EU, except for a scientific opinion to be requested under article 58 of the
same regulation – created a crisis need for African NRAs and DRAs, that relied most
exclusively on sponsor countries regulatory bodies, to urgently strengthen their role
and capacity in both ensuring quality, safety and efficacy of vaccines and drugs to
be use in Africa and to facilitate the introduction of new vaccines. In Africa, most
countries that are target for clinical trials have very limited expertise and
infrastructural capacity to carry out regulatory functions. Furthermore, in many
cases, local DRAs do not have the regulatory framework in place to exert their
authority in the regulation of the clinical trials.
According to one recent NRA surveys conducted by the WHO,
• 53 % of NRAs had limited or no capacity
• 37% had basic capacity
• 10% had moderate capacity.
The problems faced by most NRAs include among others:
• Inadequate legislation and regulations
• Inadequate appropriately qualified staff
• Inadequate and non-sustainable funding
• Lack of access to independent information
In October 2007, The WHO Regional Office for Africa and the Who Dept of
Immunization Vaccines and Biologicals, QSS issued a Status Report on
“Strengthening of Vaccine Regulatory Capacity in Africa”. In the Report, a previous
WHO surveys showed how 90% of DRAs in the African Region did not have the
capacity to perform their regulatory functions, and therefore were unable (87% by
their own admission) to ensure quality, efficacy and safety of drugs.
As a consequence to the above, in most developing countries, both unapproved and
unregulated medicines are circulating on the markets and unapproved and
unmonitored clinical trials are being conducted, with sometimes dire consequences
for trial participants being subjected to serious health risks.
AVAREF was established to exchange information and expertise among regulators of
countries that are target for clinical trials of priority vaccines, to promote
collaboration with Ethics Committees, to reinforce links between regulators of trials
and host countries.
AVAREF is based on the promotion of a regional approach to the NRAs creation and
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