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.

Vaccine vials (IVB)

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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Future Focus

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.


TRS 1004 - WHO Expert Committee on Biological Standardization, Sixty-seventh report


  • WHO Working Group meeting on Respiratory Syncytial Virus (RSV) Vaccine Standardization, WHO headquarters, Geneva, Switzerland, 13-15 September 2017
  • WHO Second Working Group Meeting on Developing WHO Guidelines on safe production of polio vaccines, WHO HQ Salle D, 19-20 September 2017
  • WHO Workshop on Implementation of Good Manufacturing Practices for Biological Products, Bangkok, Thailand 15-17 November 2017
  • WHO Implementation Workshop on the Quality, Safety and Efficacy of Typhoid Conjugate Vaccines, Osong, Chungju-si, The Republic of Korea, 21-13 November 2017


Technologies Standards and Norms (TSN)
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