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.
BS.2251 Guidelines on the quality, safety and efficacy of biotherapeutic protein products prepared by recombinant DNA technology: Appendix 7. Regulatory assessment of approved rDNA-derived biotherapeutics
BS.2252 Recommendations to assure the quality, safety and efficacy of recombinant human papillomavirus virus-like particle vaccines
BS.2253 WHO GMP for Biological Products - Proposed replacement of TRS 822, Annex 1
NSB: BS.2268 Guidelines on the stability evaluation of vaccine for use under extended controlled temperature conditions
- WHO Implementation workshop of regulatory expectations and assessment of biotherapeutics in the Africa region, Accra, Ghana, 8-10 September 2015
- Expert Committee on biological Standardization, WHO Headquarters, Geneva, Switzerland, 12-16 October 2015
Technologies Standards and Norms (TSN)
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