The Clinical Trial Regulation aims to create an environment that is favourable to conducting clinical trials in the European Union (EU), with the highest standards of safety for participants. On 16 April 2014 the new Regulation on clinical trials on medicinal products for human use was adopted. The Regulation entered into force on 16 June 2014 but will apply no earlier than 28 May 2016.
The Clinical Trial Regulation EU No. 536/2014 ensures that:
- the rules for conducting clinical trials are consistent throughout the EU;
- transparent information is made publicly available on the authorisation, conduct, and results of each clinical trial carried out in the EU.
The Regulation will apply to interventional clinical trials on medicines once the Regulation is in operation, and to all trials authorised under the previous legislation (Directive (EC) No. 2001/20/EC) and still ongoing three years after the Regulation has come into operation.
EU clinical trial portal and database
While authorisation and oversight of clinical trials remains the competence of EU Member States, the European Clinical Trial Regulation requires the European Medicines Agency (EMA) to develop and maintain a clinical trial portal and database to be used for the submission, authorisation and supervision of trials in the EU. It will serve as the source of public information on the clinical trial applications assessed, and all clinical trials conducted in the EU.
The functional specifications for the EU portal and database to be audited were agreed and published in December 2014, following a public consultation:
See below for further details on the public consultation process.
Updated: Article 82(1) of the Regulation requires the Agency to draw up the functional specifications together with the time frame for their implementation, in collaboration with the Member States and European Commission. The delivery timeframe was endorsed by the EMA Management Board in December 2015:
The endorsed timeframe foresees that the portal and database are planned to be available for an independent audit by August 2017. If the system receives a green light from the audit, the Clinical Trial Regulation will come into effect by October 2018 at the latest. This is a maximum timeframe, and every effort will be made to shorten it and bring the Regulation into operation as soon as possible.
Transparency requirements and implementation
Article 81(4) of the Regulation requires that information contained in the clinical trial database shall be publicly available unless one or more of the following exceptions apply:
- protection of personal data;
- protection of commercially confidential information, in particular taking into account the marketing authorisation status of the medicinal product, unless there is an overriding public interest in disclosure;
- protection of confidential communication between Member States in the preparation of their assessment;
- protection of the supervision of clinical trials by Member States.
Following publication of the functional specifications, EMA put forward a specific proposal on how to apply the exceptions that the Regulation makes to its transparency requirements and finalised two sets of requirements. Firstly, the EMA Management Board endorsed a revision of section 6 of the functional specifications document in March 2015, which sets out features that will support making information public:
- Revision of section 6 of the 'Functional specifications for the EU portal and EU database to be audited' setting out features to support making information public
Secondly, in October 2015 EMA published an appendix on disclosure rules to the functional specifications document, which describes the practical implementation of the transparency rules:
- Appendix, on disclosure rules, to the 'Functional specifications for the EU portal and EU database to be audited'
Public consultation process
EMA consulted 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. The below documents provide details, with comments listed by the number assigned to each stakeholder.
To finalise the functional specifications, EMA released a draft proposal for public consultation from 10 October to 31 October 2014. A total of 47 individuals and organisations submitted more than 500 comments:
- Draft functional specifications for the EU portal and EU database to be audited
- Overview of comments received on 'Draft functional specifications for the EU portal and EU database to be audited'
To finalise its proposals for implementing the transparency requirements, EMA released the below draft documents for public consulation from 21 January to 18 February 2015. Over 80 different individuals and organisations submitted more than 1,100 comments, which are compiled in four separate files due to the large volume of comments:
- Draft proposal for an addendum, on transparency, to the “Functional specifications for the EU portal and EU database to be audited
- Draft Appendices to Draft proposal for an addendum, on transparency, to the "Functional specifications for the EU portal and EU database to be audited
- List of Stakeholders and general comments
- Specific comments on sections 1 to 4.3
- Specific comments on section 4.4
- Specific comments on sections 4.5 to 5
For more information on the consultation on transparency requirements see:
- Questions and answers - Public consultation on implementation of transparency requirements of the European Clinical Trial Regulation
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