WHO Draft Working Document on Biowaiver Project published for Comments

The World Health Organization (WHO) has published a draft working document for comments entitled WHO Biowaiver Project - Prioritization exercise of active pharmaceutical ingredients for cycle VI (2024) and preliminary results from cycle V (2023).

Biowaivers are a way of waiving bioequivalence studies in human, which means that they are not considered necessary for product approval.

In principle, as mentioned in Annex 11 of the WHO Technical Report Series, No. 1044, 2022, the WHO "recognizes the possibility of waiving in vivo bioequivalence studies for immediate-release, solid oral dosage forms with active pharmaceutical ingredients (APIs) belonging to classes I and III according to the Biopharmaceutical Classification System (BCS), using comparative dissolution studies as surrogate proof of bioequivalence"

According to the WHO, the aim of the biowaiver guidance documents is "to reduce the risk of “bioinequivalence” to an acceptable level when granting biowaivers supporting pharmaceutical development and access to medicines."

WHO's Biowaiver Project is organized into different annual study cycles, starting with the pilot project (cycle I) in 2018.

Content of the Document

The working document numbered QAS/23.936 starts with a short background section, giving an overview of the project development. The main document is divided into the following three sections

  • Introduction
  • The revised WHO Biowaiver List
  • Prioritization exercise of active pharmaceutical ingredients for Biopharmaceutical Classification System-based classification in WHO Biowaiver Project

followed by a list of references and further reading.

Download and Comments

The document was posted on the WHO Medicines website under "Working documents in public consultation".

The WHO asks that comments should be submitted through the online platform PleaseReview™ by 10 September 2023. It is mentioned that only comments received by this deadline will be considered. Further information on the commenting process can be found on the first page of the new document.

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