New WHO Collaborating Center
The Institute for Biological Product Control (IBPC) of the National Institutes for Food and Drug Control (NIFDC) in China was designated as WHO Collaborating Center for standardization and evaluation of biologicals on 1st January 2013. This designation is the result of a productive collaboration with colleagues from NIFDC who provided technical support to numerous WHO projects in the development of international standards for vaccines and other biologicals in the past years. The initial period of designation is 4 years and the work plan for that period includes various activities that would contribute to the development of international standards for vaccines and other biologicals as well as to their implementation into regulatory practice. It is expected that productive collaboration from previous years will continue and will contribute to WHO initiative in providing technical assistance at the global, regional and country level.
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.