Health products policy and standards
Our team provides authoritative guidance and standards on quality, safety and efficacy of health products and supports countries to formulate evidence-based policies and ensure good practice throughout the value chain.

Regulatory standards

WHO has formulated international regulatory standards, 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 originator and generic medicines is of great importance given WHO's support of generic products and their potential to increase access to essential medicines.

Related documents

15 April 2025

TRS 1060 - Annex 8: Collaborative registration procedure between WHO and national regulatory authorities in the assessment and accelerated national registration of WHO-prequalified vector control products

15 April 2025

TRs 1060 - Annex 7: Good practices of national regulatory authorities in implementing the collaborative registration procedures for medical products

15 April 2025

TRS 1060 - Annex 5: WHO Biowaiver List: proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate-release, solid oral dosage forms

15 April 2025

TRS 1060 - Annex 6: Guideline on bioanalytical method validation and study sample analysis

26 April 2024

TRS 1052 - Annex 8: Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability

26 April 2024

TRS 1052 - Annex 7: WHO guideline on Biopharmaceutics ClassificationSystem-based biowaivers

26 April 2024

TRS 1052 - Annex 6: WHO Biowaiver List: proposal to waive in vivobioequivalence requirements for WHO Model Listof Essential Medicines immediate-release, solid oraldosage forms

26 April 2024

TRS 1052 - Annex 5: WHO/UNFPA female condom generic specification

30 September 2022

TRS 1044 - Annex 9: WHO/UNFPA guidance on natural rubber latex male condom stability studies

30 September 2022

TRS 1044 - Annex 6: WHO good practices for research and development facilities of pharmaceutical products

30 June 2022

TRS 1044 - Annex 10: WHO/UNFPA technical specification for TCu380A intrauterine device

10 October 2021

TRS 1033 - Annex 9: Guidelines on the implementation of the WHO Certification Scheme on the quality of pharmaceutical products moving in international commerce

10 October 2021

TRS 1033 - Annex 6: World Health Organization/United Nations Population Fund Guidance on testing of male latex condoms

10 October 2021

TRS 1033 - Annex 7: World Health Organization/United Nations Population Fund guidance on conducting post-market surveillance of condoms

10 October 2021

TRS 1033 - Annex 5: World Health Organization/United Nations Population Fund Recommendations for condom storage and shipping temperatures

9 October 2021

TRS 1033 - Annex 11: Good regulatory practices in the regulation of medical products

9 October 2021

TRS 1033 - Annex 10: Good reliance practices in the regulation of medical products: high level principles and considerations

9 March 2021

TRS 953 - Annex 2, Appendix 1: Stability testing of active pharmaceutical ingredients and finished pharmaceutical products: Stability conditions for WHO Member States by Region

30 September 2020

TRS 1025 - Annex 2: IAEA - WHO good manufacturing practices for radiopharmaceutical products

30 September 2020

TRS 1025 - Annex 11: UNFPA-WHO specifications for plain lubricants

30 September 2020

TRS 1025 - Annex 10: UNFPA-WHO technical specifications for male latex condoms

20 April 2020

TRS 1025 - Annex 13: WHO guideline on the implementation of quality management systems for national regulatory authorities

10 October 2019

TRS 1019 - Annex 6: Good practices of national regulatory authorities in implementing the collaborative registration procedures for medical products

10 October 2019

TRS 1019 - Annex 4: Protocol to conduct equilibrium solubility experiments for the purpose of Biopharmaceutics Classification System-based classification of active pharmaceutical ingredients for biowaiver

10 October 2019

TRS 1019 - Annex 5: Guidelines on import procedures for medical products

10 October 2018

TRS 1010 - Annex 11: Collaborative procedure in the assessment and accelerated national registration of pharmaceutical products and vaccines approved by stringent regulatory authorities

30 September 2018

TRS 1010 - Annex 10: WHO guidelines on stability testing of active pharmaceutical ingredients and finished pharmaceutical products

30 September 2018

TRS 1010 - Annex 9: WHO good practices for desk assessment of compliance with good manufacturing practices, good laboratory practices and good clinical practices for medical products regulatory decisions

10 October 2017

TRS 1003, Annex 5: General background notes on the list of international comparator pharmaceutical products

10 October 2017

TRS 1003 - Annex 4: WHO Global Model Regulatory Framework for Medical Devices including in vitro diagnostic medical devices

10 October 2016

TRS 966 - Annex 9: Guidance for organizations performing in vivo bioequivalence studies

30 September 2016

TRS 966 - Annex 10: WHO general guidance on variations to multisource pharmaceutical products

10 October 2015

TRS 992 - Annex 9: Good review practices: guidelines for national and regional regulatory authorities

10 October 2015

TRS 992, Annex 8 - Guidance on the selection of comparator pharmaceutical products for equivalence assessment of interchangeable multisource (generic) products

30 September 2015

TRS 992 - Annex 6: WHO recommendations for quality requirements when plant‑derived artemisinin is used as a starting material in the production of antimalarial active pharmaceutical ingredients

10 October 2014

TRS 986 - Annex 6: Guidelines on submission of documentation for a multisource (generic) finished pharmaceutical product: quality part

25 January 2013

TRS 981 - Annex 2: WHO guidelines on quality risk management

31 October 2011

TRS 961 - Annex 14: WHO guidelines for drafting a site master file

30 September 2010

TRS 957 - Annex 7: WHO guidelines for the preparation of a contract research organization master file

10 October 2008

TRS 948 - Annex 4: Guidelines on active pharmaceutical ingredient master file procedure

9 October 2008

TRS 948 - Annex 5: International Nonproprietary Names for biological and biotechnological substances: a review

10 October 2005

TRS 929 - Annex 4: WHO guidelines for sampling of pharmaceutical products and related materials

9 October 2005

TRS 929 - Annex 5: Guidelines for registration of fixed-dose combination medicinal products

10 October 2003

TRS 917 - Annex 3: WHO pharmaceutical starting materials certification scheme (SMACS): guidelines on implementation

10 October 2002

TRS 902 - Annex 9: Guidelines on packaging for pharmaceutical products