WHO adds four AIDS medicines to prequalified list

Four new AIDS medicines are being added to the WHO prequalification list. The four are: lamivudine (150mg tablet) from a newly prequalified generic manufacturer, and the antifungal fluconazole in three different strengths (50mg, 150mg, 200mg 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.

At the same time, product assessment reports on quality and bioequivalence of triple fixed-dose combination (FDCs) antiretrovirals already prequalified are being made public. WHO therefore joins the European Medicines Agency (EMEA) as the only other organisation 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 organisations (NGOs).

Furthermore, 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, says WHO.