Biomedical Research in Developing Countries - UNICRI

strengthening. In fact, while producing countries need a permanent reviewing
infrastructure to evaluate clinical trials applications and clinical data, target
countries may not need to make an investment at the same level, except when a
clinical trials is to take place. The Regional approach aims to establish regional
advisory panels for regulatory consultations, that would assist NRAs of target
countries with the adequate resources and expertise to assess clinical trials
applications, monitoring and evaluation of registration dossiers. This network
would serve as a source of expertise for countries that have to make regulatory
decisions for which they are not prepared and as a forum where countries can
discuss issues with peers as a means to build on the expertise available in the region
and strengthen the capacity of weaker countries.
Based on the United Nations vaccine prequalification process, that implies a strict
regulatory oversight by a functional NRA in the vaccine-producing country, WHO
developed a programme to assess NRAs against defined benchmarks. These external
assessments are carried out to identify gaps that are subsequently addressed in an
Institutional Development Plan to improve capacity, which is supported by WHO’s
Global Training Network on Vaccine Quality.
The Institutional Development Plan (IDP) is important as a tool to prioritize
activities, to promote advocacy and coordination between the different agencies
involved in its implementation. Although African Ministers for health, at the 56 th
Session of the WHO Regional Committee for Africa, held in Addis Ababa in
September 2006, committed to support NRAs IDPs in their countries, participating
countries are still far from developing them. Some countries are still far from
submitting their IDPs to WHO.
Some of the countries gave an overview of the various stages of IDP implementation
and what they propose to do as follows:
• Cameroon needed to review and update IDP activities before implementation and
strengthen capacity and collaboration between partners especially Ethics committee
and the Pharmacy Department Gambia to use MRC to build capacity of NRA and
seek added support for NRA, Regulatory guidelines to be put in place and finalize the
regulatory issues in the Draft Regulations. Also advocate for government to provide
funding for some activities of the IDP.
• Nigeria to request for support for joint reviews.
• Ethiopia- to review and update their guidelines.
• Cameroon- Operational research and funding of activities were already being done
by the MOH.
• Ghana introduced a new system of pharmacovigilance and uses the University to
provide expert opinion to the NRA.
Good clinical Practice (GCP) Inspection Training Courses are among the priorities of
DCVRN and AVAREF for the implementation of IDPs. In Africa, it was held in June
2007, in Harare, Zimbabwe for the first time within the framework of the
Developing Countries Vaccine Regulators Network A total of 19 representatives
from National Regulatory Authorities and Ethics Committees have participated in
the first course: Botswana (1), Ethiopia (2), Gambia (1), Ghana (1), Malawi (2),
Nigeria (1), Tanzania (1), Uganda (1), Zimbabwe (8), and Mozambique (1).
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