This report presents the conclusions of a WHO Expert Committee commissioned to make recommendations on specifications for pesticides used in public health. The aim is to promote the manufacture and use of high quality products that are both acceptable in terms of public health and effective against susceptible vectors of disease. The text includes an outline of the WHO Pesticide Evaluation Scheme (WHOPES) and an overview of recent trends in the various WHO regions.
The WHO Expert Committee on Biological Standardization is commissioned by WHO to establish detailed recommendations and guidelines for the manufacturing, licensing, and control of blood products, cell regulators, vaccines and related in vitro diagnostic tests. Members of the Expert Committee are scientists from national control agencies, academia, research institutes, public health bodies and the pharmaceutical industry acting as individual experts and not as representatives of their respective organizations or employers. The decisions and recommendations of the Committee are based entirely on scientific principles and considerations of public health. The Expert Committee on Biological Standardization meets on an annual basis since 1947 and is reponsible for the establishment of the WHO International Biological Reference Preparations and for the adoption of the WHO Recommendations and Guidelines. The Expert Committee directly reports to the Executive Board, which is the executive arm of the World Health Assembly.
This report presents the recommendations of a WHO Expert Committee commissioned to coordinate activities leading to the adoption of international recommendations for the production and control of vaccines and other biologicals and the establishment of international biological reference materials. The report starts with a discussion of general issues brought to the attention of the Committee and provides information on the status and development of reference materials for various antibodies, antigens, blood products and related substances, cytokines, growth factors, endocrinological substances and in vitro diagnostic devices. The second part of the report, of particular relevance to manufacturers and national regulatory authorities, contains revised WHO recommendations for production and control of live attenuated influenza vaccines and for production and control of pneumococcal conjugate vaccines. New WHO guidelines on the regulatory evaluation of similar biotherapeutic medicines are also provided. Also included are a list of recommendations, guidelines and other documents for biological substances used in medicine, and of international standards and reference reagent for biological substances.
The Committee reports on general issues discussed and provides information on the status and development of reference materials for various antibodies, antigens, blood products and related substances, cytokines, growth factors and endocrinological substances. The second part of the report, of particular relevance to manufacturers and national regulatory authorities, contains guidelines on the production and quality control of candidate tetravalent dengue virus vaccines and recommendations for the preparation, characterisation and establishment of international and other biological reference standards.
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