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Objectives and achievements of regulations in the UK

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

Abstract

  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.

     

Keywords

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.

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Copyright information

© Kluwer Academic Publishers 1989

Authors and Affiliations

  • J. P. Griffin

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