Speeding up access to quality medicines in Africa
Ten African countries have joined a WHO initiative that aims to speed up access to medicines and develop local expertise in medicines’ regulation.
The “accelerated registration” pilot project is a new collaboration between medicines regulators in developing countries and international experts working with WHO’s Prequalification of Medicines programme.
The project encourages national regulatory authorities to fast track the registration of medicines that have already been assessed and approved by WHO’s stringent prequalification procedure. This means that they have been evaluated for quality, safety and efficacy – based on information from manufacturers and close inspection of manufacturing and clinical sites. WHO’s list of prequalified products is a vital tool for United Nations agencies and other organizations involved in bulk purchasing of medicines.
"The project is an opportunity to build capacity and learn from best practices."
Gabriel Kaddu, National Drug Authority, Uganda
But in many countries, these medicines are also required to go through a national process of quality assurance before their use is authorized – a lengthy, expensive procedure that can discourage and delay pharmaceutical companies from applying to import their products.
Benefits from international expertise
Joelle Daviaud, quality assurance specialist at the Global Fund to Fight AIDS, Tuberculosis and Malaria, applauds the accelerated registration initiative. “Since 2002, the Global Fund has been calling for national authorities to use the conclusion made by the prequalification process instead of repeating work and spending time and money on a procedure that has already been done,” she says. “This is the first formalized attempt to do this.”
“National drug regulatory authorities normally have limited resources. This project helps them to benefit from the international expertise and rigorous standards of WHO’s Prequalification of Medicines programme,” says Milan Smid, who manages the accelerated registration project at WHO.
Sharing assessment outcomes
Under the project, when a manufacturer applies to register a prequalified product in a participating country, it agrees to share the product’s complete prequalification assessment and inspection file with a nominated person from the national regulatory authority via a secure internet site.
The national authority uses the prequalification reports to make an independent decision on whether to register the medicine in that country. Botswana’s principal pharmacist in drugs registration, Seloi Mogatle, says her country welcomes the opportunity to use WHO’s work without losing national autonomy.
According to Smid, the initiative establishes strong lines of communication about assessment and inspection outcomes with medicines regulatory authorities in developing countries and could serve as a model for collaboration among the authorities themselves, particularly in countries with similar health needs.
Information flow about use of products in countries
Gabriel Kaddu, head of drug assessment and registration at the National Drug Authority in Uganda, says his country lacks experts in medicines regulation, particularly in the assessment of quality and efficacy of medicines. “The pilot project is an opportunity to build capacity and learn from best practices,” he says. “It has created a forum for sharing and exchange with WHO’s prequalification experts from well-resourced regulatory authorities around the world.”
Smid adds that the focus is not just on getting products registered, but on maintaining a two-way flow of information once the product is in use. WHO will inform the national authority of any withdrawals, suspensions or delisting of prequalified medicines and they, in turn, will keep WHO informed about any national deregistration or issues about the medicine’s safety or efficacy. “We are open to feedback that will improve our understanding about the use of these products in countries,” he says.
Jean-René Kiechel, of the Drugs for Neglected Diseases initiative, believes the accelerated registration project has the potential to improve medicine registration globally. “This project does more than make treatment available to patients more rapidly,” he says. “It also has a positive effect on training and capacity building in the partner countries, and gives them the ultimate responsibility for their own systems, with the support of international experts.”