A large number of publications on diverse topics is produced by the biological standardization programme of WHO. These include:
- Written reports of the proceedings and conclusions of consultations and other meetings are available shortly after its conclusion.
- Guidance documents which appear on the WHO Biologicals website prior to being published in the reports of the Expert Committee on Biological Standardization (ECBS) in the Technical Report Series (TRS).
- Biological standardization study reports (BS documents) which serve as the basis for the establishment of physical reference materials by the Expert Committee (ECBS) are published.
The rapid appearance of such documents in electronic form conform with WHO's policy of impartial and evidence-based decision making. The documents posted on this site represent however, only a part of the total work of WHO in the quality control and utilization medicines, and additional information can be obtained in the home pages of the contributing areas. Paper copies of many of these documents are also available for purchase from the document centers listed in the links section below.
Links to meeting reports, the Technical Report Series, and the reference preparations are provided on individual topic pages. These can be found by using the navigational tabs on the left side of each page of this site.
Paper copies of a selected number of publications may be purchased from WHO:
BS.2251 Guidelines on the quality, safety and efficacy of biotherapeutic protein products prepared by recombinant DNA technology: Appendix 7. Regulatory assessment of approved rDNA-derived biotherapeutics
BS.2252 Recommendations to assure the quality, safety and efficacy of recombinant human papillomavirus virus-like particle vaccines
BS.2253 WHO GMP for Biological Products - Proposed replacement of TRS 822, Annex 1
NSB: BS.2268 Guidelines on the stability evaluation of vaccine for use under extended controlled temperature conditions
- WHO Implementation workshop of regulatory expectations and assessment of biotherapeutics in the Africa region, Accra, Ghana, 8-10 September 2015
- Expert Committee on biological Standardization, WHO Headquarters, Geneva, Switzerland, 12-16 October 2015
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