Regulation 536/2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (the “Regulation”)
Introduction
Traditionally, the results of clinical trials have not always been published. This is often due to an increased number of pharmaceutical companies, journals and academics being included, so greater time and money is spent producing reports of successful and interesting clinical trials. This is beginning to change with new laws in both the US and the EU requiring results to be published within a certain timeframe, regardless of the outcome of the trial. Aside from other issues surrounding data protection and confidentiality, this has sparked controversy over whether data from previous unpublished trials should now be released into the public domain.
This article covers the information currently available, the current regulatory landscape and the changes being brought in by the new legislation in the EU.
Under current legislation:
- What information is available about clinical trials?
- Must results of clinical trials be published?
What does the new EU Regulation require?
- What information must be published?
- What are the consequences of non-compliance with the Regulation?
Conclusion
The Regulation has been generally well received by the industry and it is felt that increased transparency with regards to clinical trials will benefit the companies, the participants and the health of the population in general.
Source: Eversheds LLP – Brett Rowland – Lexology
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