Biologicals

WHO Technical Report Series - TRS 987 - Sixty-fourth report

WHO Expert Committee on Biological Standardization 2013, TRS 987 is now published and available.


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.

New Publications

Upcoming events

Expert Committee on Biological Standardization

13-17 October 2014, Geneva, Switzerland

WHO Informal consultation on Recommendations to assure the quality, safety and efficacy of recombinant human papillomavirus virus-like particle (HPV-VLP) vaccines

11-12 November 2014, Geneva, Switzerland

Contacts

Quality, Safety and Standards (QSS)
Immunization, Vaccines and Biologicals (IVB)
World Health Organization (WHO)
Avenue Appia 20
1211 Geneva 27, Switzerland
Fax No. +41 22 7914971