Four new AIDS medicines added to the World Health Organization prequalification list

Jul 15 2004

Four new AIDS medicines are this week being added to the World Health Organization prequalification list, thus further increasing access to a choice of quality products.

At the same time, product assessment reports on quality and bioequivalence of triple fixed-dose combination (FDCs) antiretrovirals already prequalified will be made public. Manufacturing site inspection findings will soon also be published, which will make the WHO prequalification the most transparent of all similar quality assurance programmes to date.

The four new products being added to the list are: lamivudine (150 mg tablet) from a newly prequalified generic manufacturer and the antifungal fluconazole in three different strengths (50 mg, 150 mg, 200 mg capsules) also by a generic manufacturer.

The lamivudine tablet is an alternative to the product manufactured by Cipla that was recently delisted due to lack of proof of bioequivalence. The new listing therefore expands the range of choice for that particular product to those programmes wishing to use lamivudine. The current prequalified list now offers four different manufacturers for lamivudine — including innovator and generic products; and seven fluconazole products in different strengths from two generic prequalified manufacturers.

In keeping with the World Health Assembly resolution of 22 May 2004, WHO has taken measures to make public the assessment reports resulting from its prequalification process. WHO therefore joins the European Agency for the Evaluation of Medicines (EMEA) as the only other organization that makes such reports publicly accessible through its quality assurance programme, with the only difference being that WHO will also provide reports on generic medicines.

The public assessment reports include information about products’ compliance with international standards for quality, safety and efficacy as well as bioequivalence for generic products. This information will be particularly useful to developing country regulatory authorities, procurement agencies and non-governmental organizations (NGOs).

The WHO public assessment reports (WHOPARs) will assist in establishing the acceptability and appropriateness of a medicine and will provide indirect training and capacity building to regulators in countries that do not have sufficient regulatory capacity to fully assess products and determine their acceptability before licensing.

In an effort to provide even greater transparency, the prequalification project will make available in the next few weeks the findings resulting from inspections carried out at production sites according to Good Manufacturing Practices standards. No other quality assurance programme makes both the assessment reports and inspection findings available to the public.