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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"
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Stability testing of active pharmaceutical ingredients and finished pharmaceutical products
Annex 2, WHO Technical Report Series 953, 2009
Interchangeability
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
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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Procedure for prequalification of pharmaceutical products
Annex 3, WHO Technical Report Series 953, 2009
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Procedure for assessing the acceptability, in principle, of active pharmaceutical ingredients for use in pharmaceutical products
Annex 4, WHO Technical Report Series 953, 2009
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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
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Guidelines on active pharmaceutical ingredient master file procedure
Annex 4, WHO Technical Reports Series 948, 2008
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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
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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
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Guidance on variations to a prequalified product dossier
Annex 6, WHO Technical Report Series 943, 2007
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Guidelines on packaging for pharmaceutical products [pdf 1Mb]
Annex 9, WHO Technical Report Series 902, 2002
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Guidelines on import procedures for pharmaceutical products
Annex 12, WHO Technical Series 863, 1996
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WHO guidelines for sampling of pharmaceutical products and related materials
Annex 4, WHO Technical Report Series 929, 2005
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Counterfeit medicines
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Drug regulation
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