Clinical trial database europe

Progress updates are available below on the development of CTIS and its functionalities, rollout of training and user support. To subscribe to the newsletter, write to ct. The Clinical Trials Regulation requires all information stored in the database to be publicly available , unless exempted under the Regulation to protect:. EMA has added two sets of requirements to the functional specifications for applying the exceptions :. In preparation for the implementation of the Regulation, the European Commission published on 1 June the following guidance documents for public consultation until 31 August For more information, see European Commission: Clinical trials - Major developments.

The Agency consults on its proposals with EU Member States, the European Commission and stakeholders representing non-commercial and commercial clinical-trial sponsors, healthcare professionals and patient groups.

EMA consulted on the draft functional specifications in October A total of 47 individuals and organisations submitted more than comments:. EMA held a three-month consultation in on implementing the transparency rules. Over 80 different individuals and organisations submitted more than 1, comments:. Please do not include any personal data , such as your name or contact details.

Skip to main content. Veterinary regulatory Overview Research and development Marketing authorisation Post-authorisation. Human regulatory Overview Research and development Marketing authorisation Post-authorisation Herbal products. Clinical Trials Regulation. Aims and key benefits of the Regulation. The Regulation will require: consistent rules for conducting clinical trials throughout the EU; information on the authorisation, conduct and results of each clinical trial carried out in the EU to be publicly available.

The key benefits of the Regulation include: harmonised electronic submission and assessment process for clinical trials conducted in multiple Member States; improved collaboration, information-sharing and decision-making between and within Member States; increased transparency of information on clinical trials ; highest standards of safety for all participants in EU clinical trials. On this website you will then need to create your log in to access the published data. Home - Clinical Data Publication.

Data on this website This website contains clinical data published under the European Medicines Agency EMA policy on the publication of clinical data. EMA is the first regulatory authority worldwide to provide such broad access to clinical data. Forgot password Not sure if you have an EMA account?

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