New WHO Collaborating Center
The Division of Virology of the Paul Ehrlich Institute (PEI) in Germany was designated as WHO Collaborating Center for standardization and evaluation of vaccines on 26 August 2013. This designation is the result of a productive collaboration with colleagues from PEI who provided technical support to numerous projects in the area of WHO vaccine standardization in the past years. The Center will contribute to the development of international standards for vaccines, as well as to the implementation of recently established standards into regulatory practice at the global, regional and country level. The initial period of designation is 4 years and the work plan for that period includes various activities that would promote regulatory science in the context of standardization and evaluation of vaccines.
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.