Communities of practice
Registering new drugs: the African context
23 Feb 2010
Recent years have seen an increase in efforts to develop new treatments for neglected tropical diseases (NTDs). Once new drugs have been shown to be safe and effective, it is important that they should be brought into use as soon as possible. As with any drug, good regulatory processes are essential before approval is granted but it would be tragic if completion of these processes led to unnecessary delays.
At a Drugs for Neglected Diseases initiative (DNDi) workshop held in Nairobi in June 2009, it was noted that a lack of registration capacity in developing countries is holding back access to NTD drugs. Subsequently, DNDi has commissioned a report on the issue from the George Institute for International Health, Australia.
The report, Registering new drugs: the African context, presents new recommendations to strengthen regulatory authorisation processes in Africa for drugs against NTDs. It is intended to be a resource not only for DNDi but for the growing number of other product development partnerships (PDPs) also focusing on NTDs. (The launch of the report took place during a meeting in Pretoria of the African Expert Meeting on Pharmaceutical Innovation in Africa – see TropIKA.net News).
In his introduction to the report Bernard Pécoul, DNDi’s Executive Director says: “There is a need to think about new mechanisms and pathways, based on international cooperation, to ensure the urgent approval in developing countries of new NTD drugs and treatments, which are safe, effective and of quality”.
The 38-page report reviews the various mechanisms and strategies already available to support the registration of new drugs for NTDs in developing countries. This includes a discussion of the Article 58 mechanism established by the European Commission in 2004 to facilitate developing country registration of medicines to prevent or treat diseases of major public health interest, including NTDs. The report goes on to offer recommendations that would strengthen Africa’s medicine regulatory processes.
The report argues that there is a gap when it comes to the registration of new drugs in the endemic countries, particularly in Africa. Most regulatory authorities in Africa have experience in registering generic treatments but lack the resources to evaluate the safety, efficacy, and quality of new medicines for diseases that affect millions in their territories. They usually rely on registration by regulatory authorities in developed countries. However, regulatory authorities such as the Food and Drug Administration of the United States or the European Medicine Agency do not have sufficient knowledge to make an appropriate risk-benefit assessment for populations who are most affected.
The recommendations aim at a closer collaboration between developing and developed countries by involving regulators of endemic countries in all regulatory assessment of new drugs for neglected diseases. The report furthermore recommends that WHO extends its key role in the prequalification process of new tools against NTDs in addition to HIV/AIDS, malaria and tuberculosis.
An important recommendation is the creation of regional centres of regulatory excellence in each of Africa’s main sub-regions. These centres would help upgrade the skills and improve the efficiency of national regulatory agencies.
Annexes to the report address such issues as the functions of medical regulatory agencies and the regulation of clinical trials of new products.
Speaking at the launch of the report, Bernard Pécoul said, “DNDi and its partners are committed to deliver new treatments for neglected diseases. We strongly believe that African regulators have a crucial role to assess health tools being used to respond to specific patients needs in their countries”.
Mary Moran from the George Institute for International Health agreed: “African regulators need to be involved very early in the regulatory assessment of drugs developed for African needs. This is essential to strengthen African regulatory capacity in the long term and to assume the responsibility of addressing the needs of their population”.
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