Important (international) Regulatory documents

European Medicines Agency (EMA), Europe

  • Guideline on the investigation of Bioequivalence (January 2010): click here

 

World Health Organization (WHO)

  • WHO Expert Committee on Specifications for Pharmaceutical Preparations - 50th Report (April 2017): click here

 

US Food and Drug Administration (FDA), United States

  • Guidance for Industry - Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System (August 2000): click here)
  • Guidance for Industry - Bioavailability and Bioequivalence Studies for Orally Administered Drug Products - General Considerations (March 2003): click here
  • Guidance for Industry - Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs - General Considerations (March 2014): click here
  • Draft Guidance: "Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System" (May 2015): click here

 

Ministy of Health, Labour and Welfare, Japan

  • Guideline for Bioequivalence Studies for Different Strengths of Oral Solid Dosage Forms: click here
  • Guideline for Bioequivalence Studies for Formulation Changes of Oral Solid Dosage Forms: click here
  • Guideline for Bioequivalence Studies of Generic Products: click here
  • Guideline for Bioequivalence Studies for Different Solid Oral Dosage Forms: click here.

A summary of the contents of these guidances has been prepared by the Focus Group (Rapporteur: M. Mehta): click here

 

Federal Service on Surveillance in Healthcare and Social Development of Russian Federation, Russia

  • Methodological recommendations for drug manufacturers on in vitro equivalence test for generic drug products according to biowaiver procedure (draft version 2010, click here). Translated with the kind cooperation of Dr I.E. Shohin, Scientific Center for Expertise of Medical Products, Moscow, Russia; I.M. Sechenow First Mocsow State Medical Universtity, Moscow, Russia.