Biologicals

WHO Technical Report Series - TRS 980 - Sixty-third report

WHO Expert Committee on Biological Standardization, TRS 980 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.

UPCOMING EVENTS

WHO Drafting Group Meeting on the Revision of TRS 962, Annex 1

(Guidelines to assure the quality, safety and efficacy of recombinant human papillomavirus virus-like particle vaccines) 29-30 April 2014, WHO/HQ, Geneva

Implementation Workshop on Evaluation of Biotherapeutic Products and Evaluation of Similar Biotherapeutic products with emphasis on Monoclonal Antibody Products

13-16 May 2014, Seoul, The Republic of Korea

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