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The reports published as HC 1627 (ISBN 9780215040183), HC 1617 (ISBN 9780215040480), HC 1659 (ISBN 9780215041487), HC 1695 (9780215041524), HC 1796 (ISBN 9780215041586), HC 1696 (ISBN 9780215041593)
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 biological substances, and the establishment of international biological reference materials. Following a brief introduction, the report summarizes a number of general issues brought to the attention of the Committee. The next part of the report, of particular relevance to manufacturers and national regulatory authorities, outlines the discussions held on the development and revision of WHO Guidelines for a number of vaccines, blood products and related substances. Specific discussion areas included WHO guidance on the production and evaluation of the quality, safety and efficacy of monoclonal antibodies as similar biotherapeutic products (SBPs); blood and blood components as essential medicines; estimation of residual risk of HIV, HBV or HCV infections via cellular blood components and plasma; snake antivenom immunoglobulins; human pandemic influenza vaccines in non-vaccine-producing countries; and clinical evaluation of vaccines: regulatory expectations. In addition, the following WHO guidance documents were also adopted: WHO manual for the preparation of secondary reference materials for in vitro diagnostic assays designed for infectious disease nucleic acid or antigen detection: calibration to WHO International Standards; and Human challenge trials for vaccine development: regulatory considerations. One WHO addendum document "Labeling information of inactivated influenza vaccines for use in pregnant women" was also adopted. Subsequent sections of the report provide information on the current status, proposed development and establishment of international reference materials in the areas of: biotherapeutics other than blood products; blood products and related substances; cellular and gene therapies; in vitro diagnostics; and vaccines and related substances. A series of annexes are then presented which include an updated list of all WHO Recommendations, Guidelines and other documents on biological substances used in medicine (Annex 1). The above nine WHO documents adopted on the advice of the Committee are then published as part of this report (Annexes 2-10). Finally, all additions and discontinuations made during the 2016 meeting to the list of International Standards, Reference Reagents and Reference Panels for biological substances maintained by WHO are summarized in Annex 11. The updated full catalog of WHO International Reference Preparations is available at: http://www.who.int/bloodproducts/catalogue/en/.
The Ninety-seventh report of the Joint FAO/WHO Expert Committee on Food Additives, Rome, 31 October–9 November 2023. The report represents JECFA evaluation of technical, toxicological and epidemiological data, including the occurrence of and dietary exposure to the food additive titanium dioxide. The report also summaries JECFA assessment of the dietary exposure to three groups of flavouring agents (aliphatic primary alcohols, aldehydes, carboxylic acids, acetals and esters containing additional oxygenated functional groups; linear and branched-chain aliphatic, unsaturated and unconjugated alcohols, aldehydes, acids and related esters; and saturated aliphatic acyclic linear primary alcohols, aldehydes and acids).
The Department for Education provides funding for local authorities to pay for three and four year olds to receive their entitlement to 15 hours of free education each week. The Department devolves delivery to local authorities and providers but it is responsible for the overall value for money from the system. In 2011-12 the Department's estimated funding for the entitlement of £1.9 billion provided over 800,000 three and four year olds with access to free education; an estimated annual allocation of approximately £2,300 per child. While the Department and local authorities have focused on ensuring places for children are available, there has been less attention on how value for money can be secured and improved. While there is evidence of educational improvement at age five, the evidence that this is sustained is questionable. The Department needs to do more to understand how educational benefits can be lasting. There is not enough good information for parents to make informed choices and there is concern at reports that some families are still not receiving the entitlement free of charge. It is important that all parents know what the entitlement is and that it should be provided completely free. Early years education has the greatest benefit for children from disadvantaged backgrounds however these children have the lowest levels of take-up and deprived areas have the lowest levels of high quality services. The Department needs to identify and share good practice from those local authorities which are having the most success.
The Department for Education is distributing £56.4 billion in 2011-12 to schools, local authorities and other public bodies for the delivery of education and children's services in England. The Department has set out how it intends to provide Parliament with assurance about the regularity, propriety and value for money in an Accountability System Statement (the Statement) of which the Committee has now seen three drafts. Responsibility for value for money is shared by the Department with schools, academy trusts, local authorities, the Young People's Learning Agency and the Department for Communities and Local Government. However, the Statement does not yet clearly describe the specific responsibilities of each body, how these will interact, or how the Department will assess value for money across the entire education system. The Department relies on local authorities and the YPLA to exercise financial oversight over local authority maintained schools and academies respectively. However, oversight by some local authorities is currently weak and could worsen as many authorities reduce the resources they devote to overseeing their schools. There are also concerns about whether the YPLA will have the right skills, systems and capacity to oversee the rapidly increasing numbers of academies expected in coming years. More consistent requirements for data and data returns must be applied to all schools so that academic and financial performance can be benchmarked, and all schools can be held accountable. The Department needs to enforce these requirements more stringently, particularly given previous problems with lack of compliance