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Clinical trials

The Clinical Trials Directive is concretised further by " Commission Directive 2005/28/EC

of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products" (Good Clinical Practice - " the GCP Directive ").

Clinical trials submitted in any marketing authorisation application in the EU are required to be conducted in accordance with the Clinical Trials Directive. If the clinical trials are conducted outside the EU, but submitted in an application for marketing authorisation in the EU, they have to follow the principles which are equivalent to the provisions of the Clinical Trials Directive (cf. Annex I, point 8 of the " Directive 2001/83/EC

of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use" - " the Community Code for medicinal products ").

Guidelines

There are a number of guidelines further specifying various aspects of clinical trials, and in particular:

• The information to be submitted to the competent authorities and to the ethics committees
• The requirements on safety monitoring and the reporting of adverse reactions
• The requirements regarding Good Clinical Practice, including the documentation, of the clinical trials
• The specific requirements regarding the products and the clinical trials
• The inspections of competent authorities and the applicable procedures

These guidelines have been published by various bodies:

• By the European Commission: In this case, they are published in Volume 10 of "EudraLex - The rules governing medicinal products in the European Union"
• By the European Medicines Agency ("EMEA")

These guidelines concern in particular:

1. Inspection procedures and guidance for GCP inspections conducted in the context of the Centralised Procedure

2. Requirements relating to the quality, safety and efficacyof products, as well as specific types of products. Volume 3 of EudraLex

Moreover, the Heads of Medicines Agencies have established a Clinical Trials Facilitation Group ("CTFG") (in which the Commission and EMEA are observers), in order to discuss ongoing technical issues.

EudraCT

A European database - EudraCT - contains all ongoing or completed interventional clinical trials of medicinal products falling within the scope of Directive 2001/20/EC, i.e. with at least one investigator site in the EU (incl. the European Economic Area) and commencing after implementation of Directive 2001/20/EC by the Member States. This database gives the competent authorities of the Member States, the EMEA and the Commission the necessary information to communicate on clinical trials and to maintain oversight of clinical trials and IMP development. This provides for enhanced protection of clinical trial subjects and patients receiving IMPs. More information, including a user manual for EudraCT is available on the EudraCT Supporting Documentation web page.

Paediatric clinical trials that form part of a Paediatric Investigation Plan (PIP) but are conducted in third countries will also be included in the near future (paediatric clinical trials with sites in the EU/EEA are already included). Moreover, in the future, some information contained in EudraCT is going to be available to the public.

Transparency of clinical trial data in EudraCT

Community legislation provides that certain information contained in EudraCT is to be made accessible to the public. This public accessibility concerns clinical trials with paediatric as well as non-paediatric participants. It englobes protocol-related information and result-related information. And it covers both negative and positive results.

To implement the legislation further, the Commission has issued a set of guidelines, which are accessible via chapter V of EudraLex, Volume 10.

These guidelines consist of two "mother guidelines" (Guideline 2008/C168/02 and Guideline 2009/C28/01), setting out the principles, responsibilities, and procedural aspects. The "mother guidelines" are further concretised by way of a number of very detailed "daughter guidelines".

With regard to protocol-related information, programming of EudraCT in order to allow public accessibility is ongoing and is expected to be finalised during the first half of 2010.

With regard to result-related information, this information is presently not contained in EudraCT at all. Therefore, prior to making anything public, work has to focus on the format and procedure to submit this information by the sponsor in the first place. Programming has to be adapted to this. Therefore, it is unlikely that result-related information can be made available publicly via EudraCT before end of 2010.

For all additional information, reference is made to the applicable guidelines in chapter V of EudraLex, Volume 10.

Assessment of the functioning of the "Clinical Trials Directive”

In its Communication of 10 December 2008 to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions on “Safe, Innovative and Accessible Medicines: a Renewed Vision for the Pharmaceutical Sector”, the Commission announced that an assessment would be made of the application of the Clinical Trials Directive.

This assessment would consider, in particular, various options for improving the functioning of the Clinical Trials Directive with a view to making legislative proposals, if appropriate, while taking the global dimension of clinical trials into account.

A public consultation document along this line is published here [134 KB] . Interested parties are invited to comment by 8 January 2010.

Useful contact points

For further information, please find below the relevant contact points:

• Concerning the regulatory framework for clinical trials
• Concerning guidelines on inspections
• Concerning EudraCT
• Member State contacts

Other useful links

• Guidelines on clinical trials of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
• Council for International Organizations of Medical Science (CIOMS)
• World Medical Association (WMA)
• International Clinical Trials Registry Platform (ICTRP) of the World Health Organisation (WHO)