Prequalification programme for selected APIs

The WHO is today initiating a pilot prequalification programme for selected APIs used in drugs for HIV and related diseases, antimalarials and anti-tuberculosis medications.

Globalisation of the active pharmaceutical ingredient (API) supply chain has made it more difficult to ensure quality. In response the World Health Organization (WHO) Prequalification of Medicines Programme (PQP) is expanding beyond finished pharmaceutical products (FPP) to cover APIs. As part of its evaluation of FPPs the WHO looks at API master files (APIMF) and, if risk assessment indicates it is necessary, inspects manufacturing sites to ensure compliance with good manufacturing practices (GMP).

Now, when an API in the pilot programme is submitted for evaluation it will generally undergo both dossier assessment and inspection of the manufacturing facility. Details of each prequalified API, such as the supplier and manufacturing sites, will be added to a list maintained by the WHO.Manufacturers of FPPs will be able to access the list to ensure they source quality APIs. Likewise, national medicines regulatory authorities can use the database to verify the quality of APIs used in registered drugs and those submitted for approval.

The WHO anticipates use of prequalified APIs will shorten the time needed to prequalify FPPs. Any APIMFs the WHO has already accepted in relation to the prequalification of an FPP may be included on the list of prequalified APIs without reassessment or reinspection.Currently the programme is open to certain APIs, chosen by the WHO based on whether APIMFs have already been submitted in connection with an FPP evaluation.