Biologicals

Regulation and licensing

Biological products, regulation and licensing

Title 1: Regulation and licensing of biological products in countries with newly developing Regulatory Authorities; Adopted at ECBS 1994; Reference: TRS No 858, Annex 1
Title 2: Guidelines for national authorities on quality assurance for biological products; Adopted at ECBS 1991; Reference: TRS No 822, Annex 2

NEW PUBLICATIONS

RECENT PUBLICATIONS

UPCOMING EVENTS

WHO Implementation Workshop: Characterization of cell banks for the production of biologicals, 27-29 May 2013 and WHO Informal Consultation on regulatory risk assessment in the case of adventitious agent finding in a marketed vaccine, 30-31 May 2013, Beijing, Republic of China

WHO Informal Consultation on the Scientific and Regulatory Considerations on the Stability Evaluation of Vaccines under a Controlled Temperature Chain, Langen, Germany, 4-6 June 2013

Expert Committee on Biological Standardization, Geneva, Switzerland, 21-25 October 2013

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