Clinical trials - Major developments

27/05/2014
The New Regulation No 536/2014 of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC was published in the Official Journal on 27 May 2014.

16/04/2014
The new Regulation No 536/2014 of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC was adopted on 16 April 2014

02/04/2013
Statement by Health Commissioner Tonio Borg following the vote in Parliament on the Clinical Trials Regulation 

20/12/2013
Health Commissioner, Tonio Borg, welcomes agreement on the revision of EU rules on Clinical Trialspdf(69 KB)

23/04/2013
Responses to the Public consultation on the template for the qualified person’s declaration concerning GMP compliance of investigational medicinal products manufactured in non-EU countries .

06/02/2013
Template for the qualified person’s declaration concerning GMP compliance of investigational medicinal products manufactured in non-EU countries - draft submitted for public consultationpdf(35 KB).
Stakeholders are invited to comment on this draft by 2 April 2013 at the latest. Responses should be sent preferably by e-mail to sanco-pharmaceuticals-d6@ec.europa.eu, or by post to Unit SANCO/D/6, DM24 02/050, BE-1049 Brussels.

22/01/2013
Technical guidance on the format of the data fields of result-related information on clinical trials submitted in accordance with Article 57(2) of Regulation (EC) No 726/2004 and Article 41(2) of Regulation (EC) No 1901/2006 pdf(278 KB)

EudraLex, Volume 10 >>>.

11/10/2012
The Commission has published its Guidance on posting and publication of result-related information on clinical trials in relation to the implementation of Article 57(2) of Regulation (EC) No 726/2004 and Article 41(2) of Regulation (EC) No 1901/2006.pdf(774 KB) Choose translations of the previous link български (bg) čeština (cs) dansk (da) Deutsch (de) eesti keel (et) ελληνικά (el) español (es) français (fr) italiano (it) latviešu valoda (lv) lietuvių kalba (lt) magyar (hu) Malti (mt) Nederlands (nl) polski (pl) português (pt) română (ro) slovenčina (sk) slovenščina (sl) suomi (fi) svenska (sv)

17/07/2012
Commission adopts Proposal for a 'Clinical Trials Regulation'.

The Commission has adopted, on 17 July 2012, a Proposal for a Regulation of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC.
This proposal, once adopted by the EU-legislator, is going to replace the 'Clinical Trials Directive' of 2001.
More information > > >

03/05/2012
Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trialspdf(186 KB)

12/04/2012
Guidance documents applying to clinical trials - Questions & Answers Document, Version 10.0 (April 2012)

The Questions and Answers document in the EudraLex chapter on clinical trials has been revised. The version 10.0 of this document is available herepdf(83 KB).

07/03/2012
Commissioner Dalli delivers speech on "Clinical Trials Directive – Meeting Patients' Needs"pdf

26/08/2011
Guidance documents applying to clinical trials - Questions & Answers Document, Version 9.0 (August 2011)

The Questions and Answers document in the EudraLex chapter on clinical trials has been revised. The version 9.0 of this document is available herepdf(86 KB).

07/07/2011
Summary of responses to the Public consultation on the concept paper on the Revision of the 'Clinical Trials Directive' 2001/20/EC.

The Summary is published here.

23/06/2011
Responses to the Public consultation on the concept paper on the Revision of the 'Clinical Trials Directive' 2001/20/EC.

The responses are published here.

14/06/2011
Revision of the "Detailed guidance on the collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use (‘CT-3’)

For the text, see chapter II of EudraLex, Volume 10.

This revision replaces the following three documents:
- "Revision 2 of the Detailed guidance on the collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use (‘CT-3’)";
- The "Detailed guidance on the European database of Suspected Unexpected Serious Adverse Reactions (Eudravigilance - Clinical Trial Module)"; and
- The "Questions & Answers specific to adverse reaction reporting in clinical trials"

22/03/2011
Pharmaceuticals: today, the EU Register of Clinical Trials is launched Onlinepdf(17 KB)
From today, all EU citizens will have access to information on the thousands of authorised pharmaceutical clinical trials that are underway in the EU. The aim of this official public register is to make clinical research on pharmaceuticals more transparent for patients and others and to avoid unnecessary duplication of clinical trials. Every year approximately 4000 clinical trials are authorised in the EU. Since most of them last 2 to 3 years, this means that around 10 000 trials are ongoing at any given time.

Europa - Press releases

The clinical trials register: https://www.ClinicalTrialsRegister.eu

18/03/2011
Guidance documents applying to clinical trials - Questions & Answers Document, Version 8.0 (March 2011)
The Questions and Answers document in the EudraLex chapter on clinical trials has been revised. The version 8.0 of this document is available here .

Guidance on Investigational Medicinal Products (IMPs) and 'non investigational medicinal products' (NIMPs), rev.1 (March 2011)
This is a revision of the Guidance on Investigational Medicinal Products (IMPs) and 'non investigational medicinal products' (NIMPs), which had been published in 2007. The main change relates to point 3.3 and the additional annex 2 setting out documentation requirements for NiMPs in the application dossier. This revision completes the detailed guidance CT-1, which sets out the framework of a harmonised dossier requirements in the request for authorisation of a clinical trial to the national competent authority. The document is available here .

14/02/2011
Responses to the public consultation on the "Draft Implementing technical guidance - List of fields for result-related information to be submitted to the 'EudraCT' clinical trials database, and to be made public, in accordance with Article 57(2) of Regulation (EC) No 726/2004 and Article 41 of Regulation (EC) No 1901/2006 and their implementing guidelines 2008/C168/02 and 2009/C28/01The responses are published below. One submitting party (SEC Associates) requested not to publish its submission.

9/02/2011
Public consultation on a concept paper on the revision of the 'Clinical Trials Directive' 2001/20/EC.

The European Commission is planning to put forward, in 2012, a legislative proposal to revise the Clinical Trials Directive 2001/20/EC.
This concept paperpdf(94 KB) is being put out for public consultation. It presents:

  • a 'preliminary appraisal' of which option appears to be the most suitable one to address some of the key concerns of the Clinical Trials Directive, on the basis of the current state of the impact assessment; and
  • the main figures that are being used to evaluate the impacts of the different policy options.

9/12/2010
ICH guideline E2F - Note for guidance on development safety update reports The ICH guideline E2F gives sponsors guidance as to how to draw up the yearly safety report (Article 17(2) of the 'Clinical Trials Directive' 2001/20/EC).To give additional support, ICH has established 'model DSURs' which are accessible here . These 'model DSURs' take account of the differing knowledge about a medicine, depending on whether the sponsor holds the marketing authorisation or not.

9/11/2010
EudraCT - list of additional fields contained in EudraCT (reasons for negative opinions of the Ethics Committee) In accordance with point 3.3. of Commission Guidance 2009/C28/01 on the information concerning paediatric clinical trials to be entered into the EU Database on Clinical Trials (EudraCT), where a negative opinion on a clinical trial bas been issued by an Ethics Committee, the information on the trial will be published, together with a field indicating the reason for the negative opinion. This document lists the fields which are going to be contained in EudraCT. This list is an addendum to the technical guidance on EudraCT contained in EudraLex Volume 10. The document is here.

9/11/2010
Public consultation on "draft revised version of detailed guidance on the collection, verification and presentation of adverse reaction reports arising from clinical trials on medicinal products for human use (‘CT-3’)".The responses are published below. One submitting party (Actavis) requested not to publish its submission.

30/09/2010

Guidance documents applying to clinical trials - Questions & Answers Document, Version 7.0 (September 2010) The Questions and Answers document in the EudraLex chapter on clinical trials has been revised. The version 7.0 of this document is available here.

22/09/2010

Public consultation on draft guidance - Harmonised requirements for non-investigational medicinal products in CTA submissions.The responses are published below:

03/09/2010

Important change to the planned production of EudraCT Version 8.0 and the Clinical Trials Application FormThe production of EudraCT Version 8.0 has been delayed. Consequently, Revision 4 dated November 2009 of the Clinical Trials Application Form will not apply for the time being. For more information please refer to the EudraCT website.

20/07/2010

Note to Clinical Trials Application Form.EudraCT Version 8.0 will go into production on 7 September 2010. EudraCT Version 8.0 will use the Clinical Trials Application Form (Annex 1 Revision 4 dated November 2009).Consequently, the Clinical Trials Application Form (Annex 1 Revision 4 dated November 2009) will apply as of 7 September 2010.More information is available here.

17/06/2010

Public consultation document – draft revised version of detailed guidance on the collection, verification and presentation of adverse reaction reports arising from clinical trials on medicinal products for human use (‘CT-3’)This draft is a revision of the existing detailed guidance of the Commission on adverse reaction reporting, including SUSAR reporting. This initiative is a response to many calls from stakeholders during the public consultation on the functioning of the Clinical Trials Directive for short-term improvements/clarifications of the detailed rules for safety reporting. These improvements have to be necessarily limited to what is possible under the current legal framework. The revision of the Clinical Trials Directive is a medium/long-term project, conducted in parallel to this public consultation and aiming at more structural improvements of the situation for investigators and sponsors. The public consultation document is available herepdf(88 KB).

01/06/2010

Public consultation document: Draft Implementing technical guidance - List of fields for result-related information to be submitted to the 'EudraCT' clinical trials database, and to be made public, in accordance with Article 57(2) of Regulation (EC) No 726/2004 and Article 41 of Regulation (EC) No 1901/2006 and their implementing guidelines 2008/C168/02 and 2009/C28/01
At present, no result-related data is uploaded in EudraCT. This draft document sets out the details as to how result-related information should be uploaded in EudraCT in the future.This draft document is herewith submitted for public consultation.
It is available here: Guidancepdf(36 KB)- Annexpdf(165 KB).
Apart from this initiative, please note that the information contained in EudraCT (ie protocol-related information) is going to be made publicly accessible, in accordance with the applicable guidelines, in September 2010.
Public consultation on draft guidance - Harmonised requirements for non-investigational medicinal products in CTA submissionsThis draft guidance aims at clarifying the dossier-requirements for so-called non-investigational medicinal products. It is herewith submitted for public consultation. The consultation document is accessible herepdf(43 KB).
Update of substantial amendment notification form and end of trial notification formThe substantial amendment notification form and end of trial notification form have been aligned to the revised version of the "Detailed guidance on the request to the competent authorities for authorisation of a clinical trial on a medicinal product for human use, the notification of substantial amendments and the declaration of the end of the trial."The updated forms are available in Volume 10 of EudraLex.
Guidance documents applying to clinical trials - Questions & Answers Document, Version 6.0 (June 2010)
The Questions and Answers document in the EudraLex chapter on clinical trials has been revised. The version 6.0 of this document is available here.

30/03/2010
Summary of the Responses to the public consultation paper "Assessment of the functioning of the 'Clinical Trials Directive' 2001/20/EC"pdf(61 KB)This document summarises the responses to the public consultation paper "Assessment of the functioning of the 'Clinical Trials Directive' 2001/20/EC"
Revision of Detailed guidance for the request for authorisation of a clinical trial on a medicinal product for human use to the competent authorities, notification of substantial amendments and declaration of the end of the trial (Version of March 2010).
This Document is available in Volume 10 of EudraLex.
Guidance documents applying to clinical trials - Questions & Answers Document, Version 5.0 (March 2010)The Questions and Answers document in the EudraLex chapter on clinical trials has been revised. The version 5.0 of this document is available in Volume 10 of EudraLex. Annex VI to Guidance for the conduct of GCP inspections - Record keeping and archiving of documents (March 2010)This Document is available in Volume 10 of EudraLex.

11/02/2010
Responses to the Public consultation paper "Assessment of the functioning of the 'Clinical Trials Directive' 2001/20/EC"
The responses are accessible here.

03/12/2009
Detailed guidelines on good clinical practice specific to advanced therapy medicinal productsThe EU Regulation 1394/2007 on advanced therapy medicinal products requires the Commission to draw up detailed guidelines on good clinical practice (“GCP”) specific to advanced therapy medicinal products (“ATMPs”). These guidelines are published here.
These detailed guidelines do not replace but supplement the principles and detailed guidelines set out in Community laws and guidelines. These detailed guidelines specific to ATMPs should be read in conjunction with the existing detailed guidelines on GCP.03/12/2009Questions & Answers specific to adverse reaction reporting in clinical trialsThis document is published here.

10/11/2009
Publication of responses to the Public consultation on draft revision 3 of Detailed guidance for the request for authorisation of a clinical trial on a medicinal product for human use to the competent authorities, notification of substantial amendments and declaration of the end of the trial. One respondent (Actogenix) asked for confidential treatment of the submission.

09/10/2009 Assessment of the functioning of the "Clinical Trials Directive” 2001/20/EC -
Public consultation paper More information is available herepdf(134 KB).

09/10/2009
Information for interested parties: The launch into production of Version 8 of EudraCT, as well as the publication of the protocol-related information contained in EudraCT, have been postponed, for reasons related to IT, to the first half of 2010.

28/07/2009
The "Questions and Answers document" in the EudraLex volume 10 on clinical trials has been revised. The revised version 4.0 of this document is available herepdf .

22/06/2009
Public consultation on draft revision 3 of Detailed guidance for the request for authorisation of a clinical trial on a medicinal product for human use to the competent authorities, notification of substantial amendments and declaration of the end of the trial. The Clinical Trials Directive provides a regime of authorisation of the NCA, notification of substantial amendments, and declaration of the end of the trial, and exhaustively harmonises these aspects. The Commission is under an obligation to draw up detailed guidance to ensure that the format and content of the request for authorisation of a clinical trial are harmonised. A draft revision of the existing detailed guidance is being submitted for public consultation. Contributions should be sent by e-mail to entr-pharmaceuticals@ec.europa.eu.
The document is accessible herepdf(135 KB) .
Deadline for public consultation: 8 September 2009

22/06/2009
Request for authorisation of a clinical trial on a medicinal product for human use to the competent authorities and for opinion of the Ethics Committees in the Community - revised application form applicable as of Q4 of 2009.
Recent changes in the regulatory framework for pharmaceuticals and clinical trials in the EU (mainly consequences of the paediatrics legislation and the legislation on advanced therapies) have required changes to the clinical trials application form. This is the revised version of the clinical trials application form. It will become applicable in the course of Q4 2009, and is published here in advance to allow stakeholders time for preparation. A precise date for applicability is going to be published by the Commission and EMEA in due course and will coincide with the launch into production of Version 8 of EudraCT.

22/06/2009
The "Questions and Answers document" in the EudraLex volume 10 on clinical trials has been revised. The revised version 3.0 of this document is available here.

08/06/2009
Guidance for coordination of GCP inspections and co-operation between GCP inspectors, the reference and concerned Member States and CMD(h) , in the context of the evaluation of the GCP compliance of marketing authorization applications for mutual recognition and decentralized procedures has been published today in EudraLex. The text is accessible here.

13/05/2009
Revision 1 of Guidance for exchange of GCP Inspection Reports according to Article 15(2) of Directive 2001/20/EC has been published today in EudraLex. The guidelines is accessible here.

04/02/2009
Guidelines concerning paediatric clinical trials to be entered into the EU Database on Clinical Trials (EudraCT), and on EudraCT information to be made public by the European Medicines Agency have been published today in EudraLex. The guidelines are accessible here.

16/12/2008
Guidance documents applying to clinical trials - Publication of "Questions & Answers" Document, Version 2.0 (December 2008) The Questions and Answers document in the EudraLex chapter on clinical trials has been revised. The version 2.0 of this document is available here.

05/11/2008
Publication of additional guidelines on GCP inspections According to Article 29 of the Commission Directive 2005/28/EC laying down principles and detailed guidelines for good clinical practices, the Commission shall publish guidance on the conduct of inspections by the competent authorities of the different Member States.Annexes V (Phase I units) and VII (Bioanalytical part, Pharmacokinetic and Statistical Analyses of Bioequivalence Trials) to these guidelines have now been published in EudraLex - Volume 10. Moreover, the Commission has issued Guidelines for the procedure for standardisation of GCP inspection entries in EudraCT. For more information, click here.

22/10/2008
Publication of responses to the "Public consultation on the Revised Clinical Trial Application Form as regards advanced therapy investigational medicinal products". Following this public consultation, 7 responses were submitted to the European Commission. These inputs are presently carefully studied in order to finalise the application form. The responses are published below:

21/10/2008
Publication of responses to the "Public consultation on the data fields contained in the 'EudraCT' clinical trials database to be included in the 'EudraPharm' database on medicinal products and made public." Following this public consultation, 17 responses were submitted to the European Commission. These inputs are presently carefully studied in order to finalise the guideline. The responses are published below:

15/10/2008
Publication of responses to the "Commission public consultation: Implementation of the Advanced Therapies Regulation: public consultation on good clinical practice specific to advanced therapy medicinal products"

13/10/2008
Publication of responses to the "Public consultation on the data fields of the clinical trials database (EudraCT) and the information on trial results for paediatric clinical trials to be made publicly available"
Following this public consultation, 9 responses were submitted to the European Commission. These inputs are presently carefully studied in order to finalise the guideline. The responses are published below:

13/10/2008
Amended public consultation on revisions of GMP Annex 13 on Investigational Medicinal Products

23/07/2008
Implementation of the Advanced Therapies Regulation: public consultation on the Revised Clinical Trial Application Form as regards advanced therapy investigational medicinal products

23/07/2008
Public consultation on the data fields contained in the 'EudraCT' clinical trials database to be included in the 'EudraPharm' database on medicinal products and made public

4/07/2008
Commission public consultation: Implementation of the Advanced Therapies Regulation: public consultation on good clinical practice specific to advanced therapy medicinal productspdf(69 KB)

3/07/2008
Communication from the Commission regarding the guideline on the data fields contained in the clinical trials database provided for in Article 11 of Directive 2001/20/EC to be included in the database on medicinal products provided for in Article 57 of Regulation (EC) No 726/2004

27/06/2008
Public consultation on the data fields of the clinical trials database (EudraCT) and the information on trial results for paediatric clinical trials to be made publicly availableJune 2008 Publication of guidance for GCP inspections

30/11/2007
Report on the Conference of the European Commission and the European Medicines Agency Conference on the Operation of the Clinical Trials Directive (Directive 2001/20/EC) and Perspectives for the Future Conference held on 3 October 2007 at the EMEA, Londonpdf