By World Health Organization
This file offers the suggestions of a WHO professional Committee commissioned to coordinate actions resulting in the adoption of overseas concepts to guarantee the standard, security and efficacy of vaccines, blood items and different organic drugs, and the institution of foreign organic reference criteria for those items and similar diagnostic units. The document, of specific relevance to brands and nationwide regulatory professionals, begins with a dialogue of normal matters dropped at the Committee's attention.The moment a part of the file comprises written requirements that determine overseas regulatory expectancies for the subsequent items; DNA vaccines, pertussis (whole cellphone) vaccine, plasma (human) for fractionation, rabies vaccine, and rotavirus vaccine. The document additionally offers a danger overview and defines stipulations for the secure creation of pandemic pressure influenza vaccines. The 3rd a part of the document offers info at the prestige and improvement of foreign reference fabrics for varied antibodies, antigens, blood items and similar elements, and in vitro diagnostic units.
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Extra info for WHO Expert Committee on Biological Standardization
2010) namely to: — build on existing international guidance; — to distil out key fundamental requirements; — to focus on tissue or cell products that are commonly traded across international frontiers; and — to produce clear, user-friendly documents. Accordingly, existing international guidance and regulations were reviewed to identifiy cross-cutting core requirements and to identify core requirements for specific tissues and cells. The resulting draft document aims to assist regulators, tissue bank operators and tissue and cell transplant surgeons globally by providing guidance on safety and quality requirements for the most used and distributed human tissues and cells.
There is a continuing need to ensure that all national regulatory authorities with limited resources have ready access to reliable and up-to-date information when assessing TSE risks and evaluating product safety. That information includes guidance to help minimize or eliminate the risk for transmitting BSE and vCJD to humans via biologicals and other medicinal products. int/biologicals). 18 regarding allogeneic transplantation accepted in May 2005. The aims of the resolution are: — to implement effective national oversight of procurement, processing and transplantation of human cells tissues and organs; — to cooperate in establishing guidelines to harmonize global practices; 27 — to consider setting up ethics commissions to ensure the ethical use of cell, tissue and organ transplantation; — to extend the use of living kidney donations when possible, in addition to donations from deceased donors; — to take measures to protect the poorest and most vulnerable groups from “transplant tourism” and from the sale of tissues and organs, including giving attention to the wider problem of international trafficking in human tissues and organs.
2013) and was considered by the Committee. This revision includes information on plasmid DNA vaccines for prophylactic and therapeutic use but does not cover plasmid DNA vaccines for use in gene therapy, DNA vaccines derived in eukaryotic cells, bacterial vectored plasmid DNA vaccines or synthetic oligonucleotides. These guidelines are intended to provide information and guidance to national regulatory authorities and vaccine manufacturers concerning the characteristics, production, quality control and nonclinical development of DNA vaccines.