Biologicals

Technical Report Series: biological products: general recommendations

Guidelines on evaluation of similar Biotherapeutic Products (SBPs), ECBS, 19-23 October 2009

Biological products, use of animal cells as in vitro substrates

Title 1: Requirements for the use of animal cells as in vitro substrates for the production of biologicals; Revised 1996, TRS No 878, Annex 1
Title 2: Requirements for the use of animal cells as in vitro substrates for the production of biologicals; Addendum 2003

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

Biological products, GMP

Title 1: Good Manufacturing Practices for biological products; Adopted 1991, TRS no 822, Annex 1

Biological products, rDNA

Title: Biological Products prepared by recombinant DNA technology; Adopted 1990, TRS No 814, Annex 3

Biological products, sterility

Title: General requirements for the sterility of biological substances Revised 1973, TRS No 530, Annex 4
Amendment 1995, TRS No 872, Annex 3

Technical Report Series No. 822, 1992 Annex 3

Guidelines for assurîng the quality of monoclonal antibodies for use in humans

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, WHO/HQ Geneva, Switzerland, 27–28 April 2015

WHO Informal Consultation on Regulatory risk assessment for biotherapeutic products, WHO/HQ 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