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

UPCOMING EVENTS


  • WHO Informal Consultation on Regulatory considerations for evaluation of Ebola Vaccines intended for emergency use, WHO/HQ Geneva, Switzerland, 18-19 March 2015
  • WHO Informal Consultation on Stability Evaluation of Vaccines for use in a Controlled Temperature Chain, WHO/HQ Geneva, Switzerland, 24–26 March 2015
  • WHO Informal Consultation on Amendment for Similar Biotherapeutic products of monoclonal antibodies, WCC, Geneva, Switzerland, 27–28 April 2015
  • WHO Informal Consultation on Regulatory risk assessment for biotherapeutic products, WCC, Geneva, Switzerland, 29–30 April 2015

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