Abstract
-
1.
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.
-
2.
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.
-
3.
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.
-
4.
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.
-
5.
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.
This is a preview of subscription content, log in via an institution to check access.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
Preview
Unable to display preview. Download preview PDF.
References
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)
Lundberg J G (1983). Why not scientific administration? J. Am. Med. Assoc. 256, 2795
Dukes M N G (1985). The Effects of Drug Regulation. Published on behalf of WHO (Lancaster: MTP Press)
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, 230–6
Lumley C E and Walker S R (1985). The value of chronic animal toxicology studies of pharmaceuticals — a retrospective analysis. Fundam. Appl. Toxicol. 5, 1007–24
Lumley C E and Walker S R (1986). A critical appraisal of the duration of chronic animal toxicology studies. Regul. Toxicol. Pharmacol. 6 (1), 66–72
Griffin J P (1985). Predictive value of animal toxicity studies. ATLA 12,163–70
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)
Twomey C E J and Griffin J P (1983). The information lag, has it improved? Pharm. Int., 4, 57–61
Griffin J P (1984). Is better feedback a major stimulus to spontaneous adverse reaction monitoring? Lancet 2, 1098
Marcus C J and Griffin J P (1983). New chemical-entities 1972–1982. Licensing and subsequent adverse reactions. A UK/USA comparison. Pharm. Int. 4,146–9
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)
Hass A E, Portale D B and Grossman R E (1985). New drugs: their market life and safety. Pharm. J. 234, 235–8
Griffin J P (1988). Are the British different? Int. Pharm. J. 2, 20–3
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)
Griffin J P (1986). Survey of the spontaneous adverse drug reaction reporting schemes in fifteen countries. Br. J. Clin. Pharm. 22, 835–1005
Griffin J P and Weber J C P (1986). Voluntary systems of adverse reaction reporting Part II. Adv. Drug React., Ac. Pois. Rev. 1, 23–55
Speirs C J, Griffin J P, Weber J C P, Glen Bott M and Twomey C S (1984). Demography of the UK adverse reactions register of spontaneous reports. Health Trends 16, 49–52
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)
Griffin J P and Weber J C P (1987). Product licence delays. Int. Pharm. J. 6, 232–3
Venning G R (1983). Identification of adverse reactions to new drugs I: what have been the important adverse reactions since thalidomide? Br. Med. J. 286, 199–202
Venning G R (1983). Identification of adverse reactions to new drugs II: how were 18 important adverse reactions discovered and with what delays? Br. Med. J. 286, 289–92
Venning G R (1983). Identification of adverse reactions to new drugs II (continued): how were 18 important adverse reactions discovered and with what delays? Br. Med. J. 286, 365–8
Venning G R (1983). Identification of adverse reactions to new drugs III: alerting processes and early warning systems, Br. Med. J. 286, 458–60
Venning G R (1983). Identification of adverse reactrions to new drugs IV: verification of suspected adverse reactions. Br. Med. J. 286, 544–7
Griffin J P and Long J R (1981). New procedures affecting the conduct of clinical trials in the United Kingdom. Br. Med. J. 283, 477–9
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, 254–6
ABPI (1988). Blueprint for Europe
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 1989 Kluwer Academic Publishers
About this chapter
Cite this chapter
Griffin, J.P. (1989). Objectives and achievements of regulations in the UK. In: Walker, S.R., Griffin, J.P. (eds) International Medicines Regulations. CMR Workshop Series. Springer, Dordrecht. https://doi.org/10.1007/978-94-009-0857-4_8
Download citation
DOI: https://doi.org/10.1007/978-94-009-0857-4_8
Publisher Name: Springer, Dordrecht
Print ISBN: 978-94-010-6873-4
Online ISBN: 978-94-009-0857-4
eBook Packages: Springer Book Archive