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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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 RSV vaccine standardization and clinical evaluation, Geneva, Switzerland, 3-5 February 2016
- TCV Workshop, NIBSC, Potters Bar, UK, 8-10 March 2016
- WHO informal consultation on labelling information on influenza vaccines intended to be used for pregnant women, Geneva, Switzerland, 4-5 April 2016
- WHO informal consultation on WHO guidelines on regulatory preparedness for vaccine non-producing countries in response to pandemic influenza emergency, Geneva, Switzerland, 6-7 April 2016
- WHO working group meeting on guidelines on the quality, safety and efficacy of Ebola vaccines, Geneva, Switzerland, 4-5 May 2016
Technologies Standards and Norms (TSN)
Essential Medicines and Health Products (EMP)
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