WHO Technical Report Series - TRS 987 - Sixty-fourth report
WHO Expert Committee on Biological Standardization 2013, TRS 987 is now published and available.
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 Informal Consultation on Amendment for Similar Biotherapeutic products of monoclonal antibodies, WCC, Geneva, Switzerland, 27–28 April 2015
- WHO Informal Consultation on Regulatory risk assessment for biotherapeutic products, WCC, Geneva, Switzerland, 29–30 April 2015
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