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

ESSENTIAL MEDICINES AND HEALTH PRODUCTS



UPCOMING EVENTS


  • WHO working group meeting on RSV vaccine standardization and clinical evaluation, Geneva, Switzerland, 3-5 February 2016
  • TCV Workshop, NIBSC, Potters Bar, UK, 8-10 March 2016
  • WHO informal consultation on labelling information on influenza vaccines intended to be used for pregnant women, Geneva, Switzerland, 4-5 April 2016
  • WHO informal consultation on WHO guidelines on regulatory preparedness for vaccine non-producing countries in response to pandemic influenza emergency, Geneva, Switzerland, 6-7 April 2016
  • WHO working group meeting on guidelines on the quality, safety and efficacy of Ebola vaccines, Geneva, Switzerland, 4-5 May 2016

Contacts


Technologies Standards and Norms (TSN)
Essential Medicines and Health Products (EMP)
World Health Organization (WHO)
Avenue Appia 20
1211 Geneva 27, Switzerland
Fax No. +41 22 7914971