Immunization standards

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 norms and standards

WHO has played a key role for over 50 years in establishing the WHO Biological Reference Materials necessary to standardize biological materials as well as developing WHO guidelines and recommendations on the production and control of biological products and technologies. These norms and standards, based on scientific consensus achieved through international consultations, assist WHO Member States in ensuring the quality and safety of biological medicines and related in vitro biological diagnostic tests worldwide. The Organization accomplishes this work through its biological programme, the WHO Collaborating Centers, and the WHO Expert Committee on Biological Standardization (ECBS). This also involves close collaboration with the international scientific and professional communities, regional and national regulatory authorities, manufacturers and expert laboratories worldwide.

Written guidance and reference materials

The activities of the WHO biological standardization programme include the development and establishment of written guidance and biological reference materials.

Written guidelines and recommendations describe procedures for the manufacture and quality control testing of biological medicinal products to ensure safe and effective products. Guidelines provide more general information on a range of topics of interest to National Regulatory Authorities (NRAs) and manufacturers, whereas recommendations establish the technical specifications for manufacturing and quality control of specific products. By adopting these guidance documents in their pharmacopoeias or equivalent legislation, national governments ensure that the products produced and used in their country conform to current international standards. Regulatory guidance documents also advise NRAs and manufacturers on the control of biological products, with the aim of establishing a harmonized regulatory framework for products moving in international markets.


ESSENTIAL MEDICINES AND HEALTH PRODUCTS



NEW PUBLICATIONS

UPCOMING EVENTS


  • 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