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, 232kb
Interchangeability
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Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability
pdf, 196kb
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
pdf, 233kb
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
pdf, 121kb
Annex 9, WHO Technical Report Series 937, 2006 -
Guidelines for registration of fixed-dose combination medicinal products
pdf, 142kb
Annex 5, WHO Technical Report Series 929, 2005 -
Corrected chinese version of Annex 5 — TRS 929
pdf, 371kb -
Guidance on the selection of comparator pharmaceutical products for equivalence assessment of interchangeable multisource (generic) products
pdf, 169kb
Annex 11, WHO Technical Report Series 902, 2002 -
International Nonproprietary Names for biological and biotechnological substances: a review
pdf, 132kb
Annex 5, WHO Technical Report Series 948, 2008
Prequalification
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Release procedure for International Chemical Reference Substances
pdf, 162kb
Annex 1, WHO Technical Report Series 981, 2013 -
WHO guidelines on quality risk management
pdf, 234kb
Annex 2, WHO Technical Report Series 981, 2013 -
WHO guidelines on variations to a prequalified product
pdf, 307kb
Annex 3, WHO Technical Report Series 981, 2013 -
Collaborative procedure between the WHO/PREQUAL programme and national medicines regulatory authorities in the assessment and accelerated national registration of WHO-prequalified pharmaceutical products
pdf, 217kb
Annex 4, WHO Technical Report Series 981, 2013
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Guidelines on the requalification of prequalified dossiers
pdf, 63kb
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
pdf, 47kb
Annex 11, WHO Technical Report Series 961, 2011 -
Prequalification of quality control laboratories. Procedure for assessing the acceptability, in principle, of quality control laboratories for use by United Nations agencies
pdf, 96kb
Annex 12, WHO Technical Report Series 961, 2011 -
Guidance on variations to a prequalified product dossier
pdf, 239kb
Annex 6, WHO Technical Report Series 943, 2007 -
Pharmaceutical development of multisource (generic) finished pharmaceutical products – points to consider
pdf, 202kb
Annex 3, WHO Technical Report Series 970, 2012 -
Guidelines on submission of documentation for a multisource (generic) finished pharmaceutical product for the WHO Prequalification of Medicines Programme: quality part
pdf, 453kb
Annex 4, WHO Technical Report Series 970, 2012 -
Development of paediatric medicines: points to consider in formulation
pdf, 202kb
Annex 5, WHO Technical Report Series 970, 2012 -
Recommendations for quality requirements when artemisinin is used as a starting material in the production of antimalarial active pharmaceutical ingredients
pdf, 93kb
Annex 6, WHO Technical Report Series 970, 2012
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
pdf, 119kb
Annex 15, WHO Technical Report Series 961, 2011 -
WHO guidelines for drafting a site master file
pdf, 82kb
Annex 14, WHO Technical Report Series 961, 2011 -
Procedure for assessing the acceptability, in principle, of active pharmaceutical ingredients for use in pharmaceutical products
pdf, 97kb
Annex 4, WHO Technical Report Series 953, 2009 -
Guidelines for the preparation of a contract research organization master file
pdf, 50kb
Annex 7, WHO Technical Report Series 957, 2010 -
Guidelines on active pharmaceutical ingredient master file procedure
pdf, 75kb
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
pdf, 90kb
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
pdf, 92kb
Annex 3, WHO Technical Report Series, No. 948, 2008 -
Guidelines on packaging for pharmaceutical products
pdf, 185kb
Annex 9, WHO Technical Report Series 902, 2002 -
Guidelines on import procedures for pharmaceutical products
pdf, 487kb
Annex 12, WHO Technical Series 863, 1996 -
WHO guidelines for sampling of pharmaceutical products and related materials
pdf, 959kb
Annex 4, WHO Technical Report Series 929, 2005 - Spurious/falsely-labelled/falsified/counterfeit (SFFC) medicines
- Medicines regulatory support