The European Medicines Agency (EMA) bases its scientific opinions on the results of clinical trials carried out and submitted by pharmaceutical companies. On 1 January 2015 a new EMA policy on publication of clinical data entered into force. Under this policy, the Agency proactively publishes the clinical reports submitted as part of marketing-authorisation applications for human medicines. Since 2010 the Agency has been releasing clinical-trial reports on request, under its access-to-documents policy.
Publication of clinical-trial data
The Agency is committed to continuously extending its approach to transparency. A key goal in this process is the publication of clinical-trial data for medicines once the decision-making process on an application for a European Union (EU)-wide marketing authorisation is complete.
The Agency embarked on this process because it believes that the release of data is about establishing trust and confidence in the system, because it will allow the public to better understand the Agency’s decision-making.
In addition, academics and researchers will be able to re-assess data sets. The publication of clinical reports will also help to avoid duplication of clinical trials, foster innovation and encourage development of new medicines.
Updated: Policy on publication of clinical data
In October 2014, the Agency published its final policy on publication of clinical data:
- European Medicines Agency policy on publication of clinical data for medicinal products for human use
- Q&A on the European Medicines Agency policy on publication of clinical data for medicinal products for human use
The policy entered into force on 1 January 2015. It will apply to clinical reports contained in all marketing-authorisation applications submitted after that date. The reports will be released as soon as a decision on the application has been taken.
The adoption of the policy followed extensive consultations by EMA with patients, healthcare professionals, academia, industry and other European entities. For more information on the consultation exercise, see Publication and access to clinical-trial data: an inclusive development process.
Reactive release of documents
The new policy on publication of clinical data does not replace the existing EMA policy on access to documents, adopted in 2010. The access to documents policy enables third parties to request the release of documents held by the Agency, including documents submitted as part of marketing-authorisation applications.
For more information, see:
- European Medicines Agency policy on access to documents (related to medicinal products for human and veterinary use)
- Output of the European Medicines Agency policy on access to documents related to medicinal products for human and veterinary use
- Access to documents
Between November 2010 and April 2013, the Agency released over 1.9 million pages of clinical-trial data in response to safety-related requests.
Summary results of clinical trials
The Agency is also involved in making summaries of the results of clinical trials publicly available through the EU Clinical Trials Register.
In October 2013, the Agency upgraded the EudraCT database to enable sponsors to enter result-related information from clinical trials, in line with guidance from the European Commission. As of 21 July 2014, with the launch of a final iteration of EudraCT, it is mandatory for sponsors to post results on a systematic basis, and the summary results will be made publicly available.
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- European Medicines Agency policy on publication of clinical data for medicinal products for human use (02/10/2014)
- European Medicines Agency policy on access to documents (related to medicinal products for human and veterinary use) (30/11/2010)
- Heads of Medicines Agencies / European Medicines Agency guidance document on the identification of commercially confidential information and personal data within the structure of the marketing-authorisation application: Release of information after the granting of a marketing authorisation (27/03/2012)
- Principles to be applied for the implementation of the Heads of Medicines Agencies / European Medicines Agency guidance on the identification of commercially confidential information and protected personal data in marketing-authorisation applications (27/03/2012)
- Current status of European Medicines Agency policy on publication of clinical data - Stakeholder webinar (24/06/2015)
- Publication of clinical reports (02/10/2014)
- European Medicines Agency agrees policy on publication of clinical trial data with more user-friendly amendments (12/06/2014)
- European Medicines Agency updates on development of its policy on publication and access to clinical-trial data (13/11/2013)
- Clinical trials in human medicines