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
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
WHO Collaborating Centers on Standardization on Regulatory Evaluation of Vaccines & Biotherapeutic Products: 1st meeting, Geneva, 24-26 April 2012
WHO Workshop on implementing WHO Guidelines on evaluating similar biotherapeutic products (SBPs), Xiamen, China, 28-30 May 2012
WHO Informal Consultation on the revision of the recommendations to assure the Quality, Safety and Efficacy of biological products prepared by recombinant DNA technology, Xiamen, China, 31 May-1 June 2012
CONTACTS
Quality, Safety and Standards (QSS)
Immunization, Vaccines and Biologicals (IVB)
World Health Organization (WHO)
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