Biologicals

Vaccine Standardization

The World Health Organization brings together international experts in specific fields through its biological standardization programme to develop and revise specific recommendations for the production and quality control of vaccines of major international public health importance. Authoritative, harmonized guidelines and recommendations, for use by manufacturers and regulatory authorities, are published in the reports of ECBS meetings in the WHO Technical Report Series. These include recommendations for individual vaccines, and also more general guidelines on technical or regulatory topics such as cell substrates, nonclinical evaluation, or clinical evaluation. This programme also establishes and distributes the WHO Biological Reference Materials required for the standardization of assays to laboratories around the world such as manufacturers and National Control Laboratories (NCLs) who are involved in the quality control of vaccines. This activity is critical to ensure the quality of essential vaccines in a global market.

Vaccine-specific standardization

General topics and regulatory guidance


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