Related regulatory standards
WHO has also formulated international regulatory standards on several quality related issues, which include stability, packaging, storage, and bioequivalence. Care must be taken to ensure that active pharmaceutical compounds remain stable and unaffected by packaging materials or storage conditions. Further, the establishment of bioequivalence standards between brand and generic drugs is of great importance given WHO's support of generic products and their potential to increase access to essential drugs.
Stability
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Stability Testing of Pharmaceutical Products in a Global Environment
pdf, 198kb
Dr Sabine Kopp reports on the development of World Health Organization policy on stability testing.
"Article from The Regulatory Affairs Journal" -
Stability testing of active pharmaceutical ingredients and finished pharmaceutical products
Annex 2, WHO Technical Report Series 953, 2009 -
Please note that Table 2: Stability conditions for WHO Member States by Region, in Appendix 1 to the above-mentioned Annex 2, was updated on 1 December 2010
pdf, 39kb
Interchangeability
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Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability
Annex 7, WHO Technical Report Series 937, 2006 -
Proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate-release, solid oral dosage forms
Annex 8, WHO Technical Report Series 937, 2006 - For further information on Biowaiver
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Additional guidance for organizations performing in vivo bioequivalence studies
Annex 9, WHO Technical Report Series 937, 2006 -
Guidelines for registration of fixed-dose combination medicinal products
Annex 5, WHO Technical Report Series 929, 2005 -
Chinese the corrected version of Annex 5 — TRS 929
pdf, 371kb -
Guidance on the selection of comparator pharmaceutical products for equivalence assessment of interchangeable multisource (generic) products
Annex 11, WHO Technical Report Series 902, 2002 -
INTERNATIONAL NONPROPRIETARY NAMES (INN)
International Nonproprietary Names for biological and biotechnological substances: a review
Annex 5, WHO Technical Report Series 948, 2008
Others
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Guidelines on submission of documentation for a multisource (generic) finished product: general format: preparation of product dossiers in common technical document format
Annex 15, WHO Technical Report Series 961, 2011 -
WHO guidelines for drafting a site master file
Annex 14, WHO Technical Report Series 961, 2011 -
Procedure for prequalification of pharmaceutical products
Annex 10, WHO Technical Report Series 961, 2011 -
Guidelines on the requalification of prequalified dossiers
Annex 6, WHO Technical Report Series 957, 2010 -
Guidelines on submission of documentation for prequalification of innovator finished pharmaceutical products approved by stringent regulatory authorities
Annex 11, WHO Technical Report Series 961, 2011 -
Procedure for assessing the acceptability, in principle, of active pharmaceutical ingredients for use in pharmaceutical products
Annex 4, WHO Technical Report Series 953, 2009 -
Prequalification of quality control laboratories. Procedure for assessing the acceptability, in principle, of quality control laboratories for use by United Nations agencies
Annex 5, WHO Technical Report Series 943, 2007 -
Guidelines for the preparation of a contract research organization master file
Annex 7, WHO Technical Report Series 957, 2010 -
Guidelines on active pharmaceutical ingredient master file procedure
Annex 4, WHO Technical Reports Series 948, 2008 -
Procedure for Assessing the acceptability, in principle of male latex condoms for purchase by United Nations agencies
Annex 2, WHO Technical Reports Series 948, 2008 -
Procedure for Assessing the acceptability, in principle of TCU 380A intrauterine devices for purchase by United Nations agencies
Annex 3, WHO Technical Report Series, No. 948, 2008 -
Guidance on variations to a prequalified product dossier
Annex 6, WHO Technical Report Series 943, 2007 -
Guidelines on packaging for pharmaceutical products [pdf 1Mb]
Annex 9, WHO Technical Report Series 902, 2002 -
Guidelines on import procedures for pharmaceutical products
Annex 12, WHO Technical Series 863, 1996 -
WHO guidelines for sampling of pharmaceutical products and related materials
Annex 4, WHO Technical Report Series 929, 2005 - Spurious/falsely-labelled/falsified/counterfeit (SFFC) medicines
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