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Last updated: 23 April 2012
The public health arm of the United Nations is World Health Organisation (WHO).
WHO provides guidelines in the area of quality assurance of pharmaceutical products. These guidelines are established and maintained through a consultative procedure and adopted by the WHO Expert Committee on Specifications for Pharmaceutical Preparations. They are submitted to the WHO’s governing bodies for endorsement and subsequent implementation by Member States.
WHO strives to:
The guidance documents include recommendations in the area of good manufacturing practices and inspection, product assessment and registration, distribution, quality control, laboratory services, and international trade in pharmaceuticals.
I. General guidelines
WHO has adopted the following guidelines regarding generics:
Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability, Annex 7, WHO Technical Report Series, No. 937.
Effective date: 2006
www.apps.who.int/prequal/info_general/documents/TRS937/WHO_TRS_937__annex7_eng.pdf
Proposal to waive in vivo bioequivalence requirements for the WHO model list of essential medicines immediate release, solid oral dosage forms, Annex 8, WHO Technical Report Series, No. 937.
Effective date: 2006
www.apps.who.int/prequal/info_general/documents/TRS937/WHO_TRS_937__annex8_eng.pdf
Additional guidance for organizations performing in vivo bioequivalence studies, Annex 9, WHO Technical Report Series, No. 937.
Effective date: 2006
www.apps.who.int/prequal/info_general/documents/TRS937/WHO_TRS_937_eng.pdf#page=451
Guideline on submission of documentation for a multisource (generic) finished pharmaceutical product (FPP): preparation of product dossiers (PDS) in common technical document (CTD) format
Effective date: 2010
www.apps.who.int/prequal/info_general/documents/generic_guide/GenericGuideline_PDS_CTD-Format.pdf
Guideline on submission of documentation for a multisource (generic) finished pharmaceutical product (FPP): quality part
Effective date: 2010
www.apps.who.int/prequal/info_general/documents/generic_guide/GenericGuideline_Quality.pdf
II. WHO prequalification programme
In addition to enabling wider access to medicines, the WHO prequalification programme project has contributed to improving standards of generics producers and helped enhance countries’ capacity to produce quality medicines.
WHO has adopted the following guideline regarding generics that qualify for the prequalification programme:
Guideline on submission of documentation for prequalification of multi-source (generic) finished pharmaceutical products (FPPs) used in the treatment of HIV/AIDS, Malaria and Tuberculosis
Effective date: 12 May 2005
www.apps.who.int/prequal/info_applicants/Guidelines/GuideGenericSubmitDocFPPs_08_2005_WoAnnexes.pdf
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