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


  • WHO Working Group meeting on the development of guidelines on labelling influenza vaccines intended to be used for pregnant women, WHO HQ, Geneva, Switzerland, 24-25 September 2015
  • Expert Committee on biological Standardization, WHO HQ, Geneva, Switzerland, 12-16 October 2015
  • WHO Workshop on Implementation of Guidelines for procedures and data requirements for changes to approved vaccines, Chiang Mai, Thailand, 18-20 November 2015


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