Ing. Helmut Schütz

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Fortieth Report (WHO Technical Report Series No. 937)

WHO Expert Committee on Specifications for Pharmaceutical Preparations

On 19 May 2006 the WHO’s Fortieth Report was published.

Annexes 7–9 provide an excellent overview of the current recommendations (on in vivo BE studies, biowaivers based on dissolution testing and technical/organisational requirements for CROs), namely:

• Annex 7
  Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability (425kB PDF)
• Annex 8
  Proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate-release, solid oral dosage forms (464kB PDF)
• Annex 9
  Additional guidance for organizations performing in vivo bioequivalence studies (371kB PDF)