Continuing work to increase access to biotherapeutics
The increased work of INN in the area of names for biologicals is especially timely. Increased access to biotherapeutic products was recently identified as a global public health priority, articulated in resolution WHA67.21 of the World Health Assembly. The resolution calls on WHO to provide more support to Member States to regulate biotherapeutics and make them accessible to their populations. WHO/EMP has therefore initiated a cross-departmental project on access to biotherapeutics. The aim is to bring all of the assets of the Department – its policy development and health technology assessment work in addition to its normative and regulatory support work – to provide a comprehensive framework of support and advise to Member States on biotherapeutics. The ongoing work on the bioqualifiers initiative will be an important consideration in the context of this holistic approach. We plan to convene an ad hoc committee in Q1 of 2017 to guide this work.
WHO Regulatory Standards for Vaccines and Biologicals
Established in 1947, the Expert Committee on Biological Standardization (ECBS) has overall responsibility for this area of work.
Standards developed through the ECBS relate to the production and quality control of safe and effective products. They provide guidance for national regulatory authorities and manufacturers and serve as the standard for acceptability of vaccines for supply to countries through international agencies (terms prequalification). Biological standards are also established by the Committee and provide the basis for the laboratory comparison of vaccines worldwide.
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For the foreseeable future, the emphasis for work in this area will be on the development of standards for new vaccines and novel vaccine combinations and of strategies to promote, facilitate and monitor the use of WHO standards.
As expectations for faster product development of vaccines grow, the ECBS will need to develop guidelines at an earlier stage of the production cycle.
- 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)
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