Globalisation of the API supply chain has made it more difficult to ensure quality and falsified or counterfeit medicines are a worry across the globe. In response the WHO Prequalification of Medicines Programme is expanding beyond finished pharmaceutical products to cover APIs.

As part of its evaluation process for finished pharmaceutical products the WHO already assesses API master files (APIMFs) and, if risk assessment indicates it is necessary, inspects manufacturing sites to ensure compliance with good manufacturing practices.

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, including supplier and manufacturing sites, will be added to the WHO list of prequalified APIs on their website.

Manufacturers of finished pharmaceutical products 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 finished pharmaceutical products. APIMFs that the WHO has already accepted in relation to the prequalification of an finished pharmaceutical product may be included on the list of prequalified APIs without reassessment or re-inspection.

The pilot programme is only open to certain APIs, by invitation from the WHO, and based on whether APIMFs have already been submitted in connection with an finished pharmaceutical product evaluation. More APIs are expected to be added to the programme in the future at which time the WHO Prequalification of Medicines Programme will update its website.

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