Vaccine vials (IVB)

WHO Regulatory Standards for Vaccines and Biologicals

Established in 1947, the Expert Committee on Biological Standardization (ECBS) has overall responsibility for this area of work.

Standards developed through the ECBS relate to the production and quality control of safe and effective products. They provide guidance for national regulatory authorities and manufacturers and serve as the standard for acceptability of vaccines for supply to countries through international agencies (terms prequalification). Biological standards are also established by the Committee and provide the basis for the laboratory comparison of vaccines worldwide.

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Future Focus

For the foreseeable future, the emphasis for work in this area will be on the development of standards for new vaccines and novel vaccine combinations and of strategies to promote, facilitate and monitor the use of WHO standards.

As expectations for faster product development of vaccines grow, the ECBS will need to develop guidelines at an earlier stage of the production cycle.


  • 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 HQ, Geneva, Switzerland, 12-16 October 2015
  • WHO Workshop on Implementation of Guidelines for procedures and data requirements for changes to approved vaccines, Chiang Mai, Thailand, 18-20 November 2015


Technologies Standards and Norms (TSN)
Essential Medicines and Health Products (EMP)
World Health Organization (WHO)
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