Objectives and achievements of regulations in the UK
It is difficult to assess whether the objectives of medicines regulation, namely evaluation of safety, efficacy and quality of new medicinal substances, have been achieved since no regulatory authorities regularly undertake self-analysis.
Medicines regulations have undoubtedly safeguarded the public, but whether this has been achieved through industry striving to achieve prescribed standards or through regulatory scrutiny is a matter for debate.
By reviewing product withdrawals from the UK and other markets it appears regulatory activity may have distorted the UK market for non-steroidal anti-inflammatory drugs (NSAIDs). Regulatory caution was exercised in response to increased adverse reaction reporting for NSAIDs.
The need to introduce the CTX scheme (clinical trial exemption scheme) in the UK in 1981 was a clear example of medicines de-regulation correcting the balance for a research based industry previously hindered by regulation.
In the last few years the regulatory delay in the UK for the bulk of both major and minor applications for marketing has put the UK Licensing Authority in breach of the EEC Directives.
KeywordsProduct Licence Tienilic Acid Medicinal Substance License Authority Regulatory Delay
Unable to display preview. Download preview PDF.
- 1.Griffin J P (1986). The regulatory environment in the United Kingdom: a two sided perspective. In: Lasagna L and Beam A G (eds) Innovation and Acceleration in Clinical Drug Development pp. 41–54 (New York: Raven Press)Google Scholar
- 3.Dukes M N G (1985). The Effects of Drug Regulation. Published on behalf of WHO (Lancaster: MTP Press)Google Scholar
- 4.Diggle G G and Griffin J P (1982). Licensing times in granting marketing and authorisation for medicines — a comparison between the UK and USA. Pharm. Int. 3, 230–6Google Scholar
- 7.Griffin J P (1985). Predictive value of animal toxicity studies. ATLA 12,163–70Google Scholar
- 8.Griffin J P and D’Arcy P F (1981). Adverse reactions to drugs — the information lag. Side effects of drugs essay 1981. In: Dukes M N G (ed) Side Effects of Drugs Annual 5, 1981. (Amsterdam/Oxford/Princetown: Excerpta Medica)Google Scholar
- 9.Twomey C E J and Griffin J P (1983). The information lag, has it improved? Pharm. Int., 4, 57–61Google Scholar
- 11.Marcus C J and Griffin J P (1983). New chemical-entities 1972–1982. Licensing and subsequent adverse reactions. A UK/USA comparison. Pharm. Int. 4,146–9Google Scholar
- 12.Hass A E (1982). An historical look at drug introduction in a five country market OPE Study 60. (Washington DC: United States Food and Drug Administration)Google Scholar
- 13.Hass A E, Portale D B and Grossman R E (1985). New drugs: their market life and safety. Pharm. J. 234, 235–8Google Scholar
- 14.Griffin J P (1988). Are the British different? Int. Pharm. J. 2, 20–3Google Scholar
- 15.Griffin J P (1987). Adverse drug reaction monitoring in sixteen countries and the contribution of the pharmaceutical industry to drug safety. In: Mann R D (ed) Adverse Drug Reactions pp. 75–100 (Carnforth: Parthenon Publishing)Google Scholar
- 16.Griffin J P (1986). Survey of the spontaneous adverse drug reaction reporting schemes in fifteen countries. Br. J. Clin. Pharm. 22, 835–1005Google Scholar
- 17.Griffin J P and Weber J C P (1986). Voluntary systems of adverse reaction reporting Part II. Adv. Drug React., Ac. Pois. Rev. 1, 23–55Google Scholar
- 19.Mann R D (1986). The Yellow Card Data: the nature and scale of the adverse drug reactions problem. In: Mann R D (ed) Adverse Drug Reactions pp. 5–66 (Carnforth: Parthenon Publishing)Google Scholar
- 20.Griffin J P and Weber J C P (1987). Product licence delays. Int. Pharm. J. 6, 232–3Google Scholar
- 27.Speirs C J, Saunders R M and Griffin J P (1984). The UK Clinical Trial Exemption Scheme — its effects on investment in research. Pharm. Int. 5, 254–6Google Scholar
- 28.ABPI (1988). Blueprint for EuropeGoogle Scholar