CBER staff contribute as subject matter experts on WHO Advisory Committees sharing scientific and regulatory expertise on issues within CBER’s regulatory purview.
CBER has had long-standing commitment to:
- Global Advisory Committee on Vaccine Safety
- Expert Committee on Biological Standardization
- Blood Regulators Network
Global Advisory Committee on Vaccine Safety (GACVS):
The GACVS was established in 1999 by the World Health Organization to respond promptly, efficiently, and with scientific rigor to vaccine safety issues that have potential implications for global vaccination programs. The GACVS is a standing committee with regular consultation and interaction between members to provide WHO with impartial, high quality, scientific advice and recommendations on matters related to vaccine safety. The goal of the GACVS is to address potential vaccine safety issues in a timely manner and make recommendations, as needed, to ensure continued integrity of global vaccination programs.
Expert Committee on Biological Standardization (ECBS):
The WHO Expert Committee on Biological Standardization (ECBS) was established in 1947 to provide recommendations and guidelines for the manufacturing, licensing and control of blood products and related in vitro diagnostic tests, biotechnology products and vaccines, as well as the establishment of WHO International Standards and Biological Reference Materials. The ECBS meets on an annual basis and advises on standards development activities in areas that are a public health priority, and makes recommendation to WHO regarding adoption of physical and written standards for global use.
The proceedings of the ECBS meetings are published in the WHO Technical Report Series (TRS). These publications provide information on the establishment, discontinuation and replacement of the WHO Biological Reference Materials as well as on the adoption of Guidelines and Recommendations.
Blood Regulators’ Network (BRN):
The Blood Regulators Network was established in 2006 and is comprised of leading National Regulatory Authorities that have responsibility for the regulation of blood, blood products and related in vitro diagnostic devices (IVD). The BRN focuses on scientific assessment of current and emerging threats to the safety and availability of blood and blood products, assessment of the impact of new blood-related technologies, and also explores opportunities for regulatory cooperation and collaboration, where possible. The objective of the BRN is to promote cooperation of experienced regulatory authorities in risk assessment and information-sharing, and provides a forum for the exchange of information and opinion among members on blood-related issues. BRN recommendations and considerations are communicated to the ECBS, through WHO.