Immunization standards

Vaccine regulation

National regulatory authorities

The assessment, licensure, control, and surveillance of biological medicinal products are major challenges for national regulatory authorities confronted by a steadily increasing number of novel products, complex quality concerns, and new technical issues arising from rapid scientific advances. With the emerging global market the volume of biological medicinal products crossing national borders continues to rise, and it has become critical that regulatory knowledge and experience concerning them can be shared, and approaches to their control harmonized to the greatest extent possible.

Through its consultative approach, WHO identifies and consolidates current consensus opinions on key regulatory issues, and communicates them to national authorities and manufacturers through guidance documents addressing both general issues and specific products. Through this mechanism, national regulatory authorities are informed on the scientific background needed to assess critcal issues, and are advised on which regulatory approaches and methodologies have been found to be optimal for insuring the global supply of uniformly high, quality, and efficacious biological medicinal products.



  • WHO Informal Consultation on the International Standards for Biotherapeutic Products: future direction, WHO HQ, Geneva, Switzerland, 21-22 September 2015
  • WHO working group meeting on the development of guidelines on labelling influenza vaccines intended to be used for pregnant women, WHO HQ, Geneva, Switzerland, 24-25 September 2015
  • Expert Committee on Biological Standardization, WHO Headquarters, Geneva, Switzerland, 12-16 October 2015
  • WHO Workshop on Implementation of Guidelines for procedures and data requirements for changes to approved vaccines, WHO HQ, Geneva, Switzerland, 18-20 November 2015


Technologies Standards and Norms (TSN)
Essential Medicines and Health Products (EMP)
World Health Organization (WHO)
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1211 Geneva 27, Switzerland
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