Standardization of Biotherapeutic Products

The World Health Organization brings together international experts through its biological standardization programme to develop and revise guidance on biotherapeutic products. The norms and standards programme for biotherapeutics is responsible for developing and establishing both international biological reference preparations and written standards (Recommendations and Guidelines) for these products. The promotion of WHO biological standards is undertaken in a variety of ways including rapid publication on the WHO website, as well as by the organization of post-adoption workshops to facilitate the implementation of highly complex or topical guidelines/recommendations into regulatory and manufacturers’ practice. Such workshops have proved extremely valuable not only in promoting the WHO recommendations/guidelines in question, but also as a means of obtaining information from countries about their use of WHO guidance documents and their ability to follow WHO guidance, as well on interpreting difficult aspects of the guidance given in the documents.

Biotherapeutic-specific standardization

General topics and regulatory guidance




  • WHO Informal Consultation on development of guidelines on procedures and data requirements for changes to approved biotherapeutic products including biosimilars, Seoul, Republic of Korea, 27-28 April 2017
  • Working Group meeting on revision of WHO TRS 941, Annex 5: WHO biosafety risk assessment and Guidelines for the production and quality control of human influenza pandemic vaccines, Geneva, Switzerland, 9-10 May 2017
  • Working group meeting on Hepatitis E Vaccine, Geneva, Switzerland, 11-12 May 2017


Technologies Standards and Norms (TSN)
Essential Medicines and Health Products (EMP)
World Health Organization (WHO)
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1211 Geneva 27, Switzerland
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