Safety, Quality, Efficacy: Regulating Medicines in the UK

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SAFETY, QUALITY, EFFICACY: REGULATING MEDICINES IN THE UK Bibliography Parliamentary documents Medicines Act, 1968 National Institute for Clinical Excellence, Commons Health Committee second report 2001-02, HC515, 20 June 2002 Reports by the Department of Health and associated bodies Study of control of medicines (internal Department of Health document), Dr NJB Evans, PW Cunliffe, 1988 An organisation with a memory: Report of an expert group on learning from adverse events in the NHS chaired by the Chief Medical Officer, Department of Health, 2000 Pharmacy in the future - implementing the NHS Plan, Department of Health, September 2000 Building a safer NHS for patients, Department of Health, May 2001 The withdrawal of an oral polio vaccine: analysis of events and implications, Chief Medical Officer, June 2002 A consolidated review of transmissible spongiform encephalopathy agents and the safety of United Kingdom authorised human vaccines, Committee on Safety of Medicines, June 2000 Report by the Medicines Control Agency on the development, since 1989, of guidance for the pharmaceutical industry to follow on the use of certain animal derived materials in the manufacture of medicines, and the approach taken by the Agency to its implementation, Medicines Control Agency, June 2002 Reports from other organisations in the UK Consumer Representation (policy report), Consumers' Association, 1998 Choosing the right fabric: a framework for performance information, HM Treasury and others, March 2001 Pharmaceutical Industry Competitiveness Task Force: Final report, March 2001 A spoonful of sugar, Audit Commission, December 2001 Failings in treatment advice, SPCs and black triangles, Drug and Therapeutics Bulletin, 2001; 39 Better Government Services: Executive Agencies in the 21st Century, Office of Public Services Reform, July 2002 International reports Dialogue in pharmacovigilance: more effective communication, the World Health Organisation Uppsala Monitoring Centre, May 2002 High level group on innovation and provision of medicines in the European Union (G10 Medicines Report), European Commission, May 2002 Improving the regulatory review process, Centre for Medicines Research International, 1996 Building quality measures into the regulatory review process: assessing the needs of industry and regulators, Centre for Medicines Research International, January 2001 bibliography 53
SAFETY, QUALITY, EFFICACY: REGULATING MEDICINES IN THE UK Glossary of terms Abridged application Adverse drug reaction Ayurvedic medicine Black triangle drug British Pharmacopoeia (BP) Centralised procedure Clinical trial Committee on Safety of Medicines Efficacy European Medicines Evaluation Agency Generic medicine Good Laboratory/ Manufacturing/ Distribution practice Healthy volunteer study An application to market a medicine which does not involve a new active substance, but is a new form of an existing one Any unwanted effect from taking a medicine. Monitoring concentrates on serious and/or unexpected reactions A traditional Indian medicine, classified as a herbal medicine and currently not required to be licensed A drug which is intensively monitored by the Medicines Control Agency and for which health professionals are encouraged particularly to report adverse drug reactions. The black triangle symbol appears on labels and leaflets The set of published standards for the composition and quality of medicinal substances. It also incorporates the European standards of the Pharmacopée Européenne (Ph Eur) The procedure by which a new drug obtains a Europe-wide marketing authorisation through application centrally to the European Medicines Evaluation Agency. It is the compulsory route for biotechnology products Testing of a new drug on humans before marketing. It may involve either healthy volunteers or patients An expert committee set up under the Medicines Act 1968 to provide advice on medicines safety to Ministers The extent to which a medicine has the beneficial effect intended The central body responsible for evaluating applications for Europe-wide marketing authorisations and coordinating European medicines regulation An unbranded version of an original medicine made under a different name, after patent restrictions have expired. The active ingredient is chemically identical The quality standards against which Agency inspectors assess company activities in the different stages of development, manufacture and distribution of medicines A study of a medicinal product in healthy people who volunteer to allow an investigator to test how the product is handled by the normal human body. The tests usually measure absorption, distribution, metabolism and excretion of the medicine. They may also measure its concentration in the blood after different doses. At the same time investigators measure safety by looking for adverse reactions to the drug glossary of terms Herbal medicine Homoeopathic medicine A medicine whose constituents are entirely derived from plants A medicine containing highly diluted active ingredients which would in a healthy person produce the symptoms being treated 54
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Safety, Quality, Efficacy: Regulating Medicines in the UK

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