Clinical trials
Clinical trials

The following Life Sciences practice note provides comprehensive and up to date legal information covering:

  • Clinical trials
  • The purpose of clinical trials
  • The current clinical trial regulatory framework and its upcoming reform
  • Brexit and clinical trials
  • The scope of the Clinical Trials Directive
  • Clinical trials
  • Medicinal products
  • Non-interventional trials
  • Parties involved in clinical trials
  • Subjects and informed consent
  • More...

On 31 January 2020, the UK ceased to be an EU Member State and entered an implementation period during which it continues to be treated by the EU as a Member State for many purposes. As a third country, the UK can no longer participate in the EU’s political institutions, agencies, offices, bodies (except to the limited extent agreed), but it continues to be subject to EU law and must submit to the continuing jurisdiction of the Court of Justice of the EU in accordance with the transitional arrangements in Part 4 of the Withdrawal Agreement. For further reading, see: Brexit—Life Sciences and News Analysis: Brexit Bulletin—key updates, research tips and resources.

The purpose of clinical trials

A clinical trial is an investigation conducted in human subjects which aims to discover or verify the effects of and adverse reactions to a medicinal product, ie it assesses a medicine’s efficacy and safety. In the EU, clinical trials must be conducted on new medicinal products before they can receive approval to be placed on the market, but clinical trials are also conducted on medicinal products which are already available to the public in order to demonstrate their efficacy compared to competing products or placebos. For more information on marketing authorisations (MAs) in the EU, see Practice Note: Marketing authorisations—regulatory procedures for approval of medicinal products.

The safety and protection

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