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.
LATEST NEWS: Main outcomes of the meeting of the WHO Expert Committee on Biological Standardization held from 21 to 25 October 2019
POST ECBS 2019 DOCUMENTS
Technical Report Series 1016
- WHO Typhoid Conjugate Vaccine (TCV) Guidelines Drafting Group Meeting, NIBSC, Potters Bar, UK, 25 to 26 November 2019
- WHO Informal Consultation on Guidelines for assuring the quality, safety and efficacy of DNA vaccines, WHO, Geneva, Switzerland, 9 to 10 December 2019
- WHO Workshop on implementation of International Standard and assay standardization for Respiratory Syncytial Virus (RSV) vaccines, NIBSC, Potters Bar, UK, 25-27 March 2020