Objectives and achievements of regulations in the UK

  • J. P. Griffin
Part of the CMR Workshop Series book series (CMRWS)


  1. 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. 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. 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. 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. 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.



Product Licence Tienilic Acid Medicinal Substance License Authority Regulatory Delay 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.


Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.


  1. 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
  2. 2.
    Lundberg J G (1983). Why not scientific administration? J. Am. Med. Assoc. 256, 2795CrossRefGoogle Scholar
  3. 3.
    Dukes M N G (1985). The Effects of Drug Regulation. Published on behalf of WHO (Lancaster: MTP Press)Google Scholar
  4. 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
  5. 5.
    Lumley C E and Walker S R (1985). The value of chronic animal toxicology studies of pharmaceuticals — a retrospective analysis. Fundam. Appl. Toxicol. 5, 1007–24PubMedCrossRefGoogle Scholar
  6. 6.
    Lumley C E and Walker S R (1986). A critical appraisal of the duration of chronic animal toxicology studies. Regul. Toxicol. Pharmacol. 6 (1), 66–72PubMedCrossRefGoogle Scholar
  7. 7.
    Griffin J P (1985). Predictive value of animal toxicity studies. ATLA 12,163–70Google Scholar
  8. 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. 9.
    Twomey C E J and Griffin J P (1983). The information lag, has it improved? Pharm. Int., 4, 57–61Google Scholar
  10. 10.
    Griffin J P (1984). Is better feedback a major stimulus to spontaneous adverse reaction monitoring? Lancet 2, 1098PubMedCrossRefGoogle Scholar
  11. 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. 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. 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. 14.
    Griffin J P (1988). Are the British different? Int. Pharm. J. 2, 20–3Google Scholar
  15. 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. 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. 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
  18. 18.
    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, 49–52PubMedGoogle Scholar
  19. 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. 20.
    Griffin J P and Weber J C P (1987). Product licence delays. Int. Pharm. J. 6, 232–3Google Scholar
  21. 21.
    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, 199–202CrossRefGoogle Scholar
  22. 22.
    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, 289–92CrossRefGoogle Scholar
  23. 23.
    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, 365–8CrossRefGoogle Scholar
  24. 24.
    Venning G R (1983). Identification of adverse reactions to new drugs III: alerting processes and early warning systems, Br. Med. J. 286, 458–60CrossRefGoogle Scholar
  25. 25.
    Venning G R (1983). Identification of adverse reactrions to new drugs IV: verification of suspected adverse reactions. Br. Med. J. 286, 544–7CrossRefGoogle Scholar
  26. 26.
    Griffin J P and Long J R (1981). New procedures affecting the conduct of clinical trials in the United Kingdom. Br. Med. J. 283, 477–9CrossRefGoogle Scholar
  27. 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. 28.
    ABPI (1988). Blueprint for EuropeGoogle Scholar

Copyright information

© Kluwer Academic Publishers 1989

Authors and Affiliations

  • J. P. Griffin

There are no affiliations available

Personalised recommendations