Safety, Quality, Efficacy: Regulating Medicines in the UK
Safety, Quality, Efficacy: Regulating Medicines in the UK
Safety, Quality, Efficacy: Regulating Medicines in the UK
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SAFETY, QUALITY, EFFICACY: REGULATING MEDICINES IN THE <strong>UK</strong><br />
Glossary of terms<br />
Abridged application<br />
Adverse drug reaction<br />
Ayurvedic medic<strong>in</strong>e<br />
Black triangle drug<br />
British Pharmacopoeia (BP)<br />
Centralised procedure<br />
Cl<strong>in</strong>ical trial<br />
Committee on <strong>Safety</strong> of <strong>Medic<strong>in</strong>es</strong><br />
<strong>Efficacy</strong><br />
European <strong>Medic<strong>in</strong>es</strong><br />
Evaluation Agency<br />
Generic medic<strong>in</strong>e<br />
Good Laboratory/ Manufactur<strong>in</strong>g/<br />
Distribution practice<br />
Healthy volunteer study<br />
An application to market a medic<strong>in</strong>e which does not <strong>in</strong>volve a new active substance,<br />
but is a new form of an exist<strong>in</strong>g one<br />
Any unwanted effect from tak<strong>in</strong>g a medic<strong>in</strong>e. Monitor<strong>in</strong>g concentrates on serious and/or<br />
unexpected reactions<br />
A traditional Indian medic<strong>in</strong>e, classified as a herbal medic<strong>in</strong>e and currently not required<br />
to be licensed<br />
A drug which is <strong>in</strong>tensively monitored by <strong>the</strong> <strong>Medic<strong>in</strong>es</strong> Control Agency and for which<br />
health professionals are encouraged particularly to report adverse drug reactions. The<br />
black triangle symbol appears on labels and leaflets<br />
The set of published standards for <strong>the</strong> composition and quality of medic<strong>in</strong>al substances.<br />
It also <strong>in</strong>corporates <strong>the</strong> European standards of <strong>the</strong> Pharmacopée Européenne (Ph Eur)<br />
The procedure by which a new drug obta<strong>in</strong>s a Europe-wide market<strong>in</strong>g authorisation<br />
through application centrally to <strong>the</strong> European <strong>Medic<strong>in</strong>es</strong> Evaluation Agency. It is <strong>the</strong><br />
compulsory route for biotechnology products<br />
Test<strong>in</strong>g of a new drug on humans before market<strong>in</strong>g. It may <strong>in</strong>volve ei<strong>the</strong>r healthy<br />
volunteers or patients<br />
An expert committee set up under <strong>the</strong> <strong>Medic<strong>in</strong>es</strong> Act 1968 to provide advice on<br />
medic<strong>in</strong>es safety to M<strong>in</strong>isters<br />
The extent to which a medic<strong>in</strong>e has <strong>the</strong> beneficial effect <strong>in</strong>tended<br />
The central body responsible for evaluat<strong>in</strong>g applications for Europe-wide market<strong>in</strong>g<br />
authorisations and coord<strong>in</strong>at<strong>in</strong>g European medic<strong>in</strong>es regulation<br />
An unbranded version of an orig<strong>in</strong>al medic<strong>in</strong>e made under a different name, after patent<br />
restrictions have expired. The active <strong>in</strong>gredient is chemically identical<br />
The quality standards aga<strong>in</strong>st which Agency <strong>in</strong>spectors assess company activities <strong>in</strong><br />
<strong>the</strong> different stages of development, manufacture and distribution of medic<strong>in</strong>es<br />
A study of a medic<strong>in</strong>al product <strong>in</strong> healthy people who volunteer to allow an <strong>in</strong>vestigator<br />
to test how <strong>the</strong> product is handled by <strong>the</strong> normal human body. The tests usually measure<br />
absorption, distribution, metabolism and excretion of <strong>the</strong> medic<strong>in</strong>e. They may also<br />
measure its concentration <strong>in</strong> <strong>the</strong> blood after different doses. At <strong>the</strong> same time<br />
<strong>in</strong>vestigators measure safety by look<strong>in</strong>g for adverse reactions to <strong>the</strong> drug<br />
glossary of terms<br />
Herbal medic<strong>in</strong>e<br />
Homoeopathic medic<strong>in</strong>e<br />
A medic<strong>in</strong>e whose constituents are entirely derived from plants<br />
A medic<strong>in</strong>e conta<strong>in</strong><strong>in</strong>g highly diluted active <strong>in</strong>gredients which would <strong>in</strong> a healthy<br />
person produce <strong>the</strong> symptoms be<strong>in</strong>g treated<br />
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