The new European clinical trial regulation – part 2

January 11, 2013 | By Márcio Barra

As promised, here’s part 2 of my article on the new European regulation for clinical trials. Please enjoy, and share if you like it!


In July 17, 2012, the European Commission approved a proposal for the creation of a regulation for EU clinical trials, entitled “Regulation of the European parliament and of the council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC” (12). If approved, it will come into force before 2016, followed by a three year period where it runs parallel with Directive 2001/20/EC, as to ease up MS transition into the new rules(12) (7). This regulation hopes to improve the EU clinical research environment for the next 20 years with the following changes (13):

Change of legislative nature


The new regulation addresses the deviating interpretations of the directive from the MS by virtue of being a Regulation instead of a Directive, being immediately applicable to all 27 MS once it comes into force. This ensures that all procedures governing clinical trials are the same between all MS, as the regulation provides a common, shared standard.


New authorization procedure


The new regulation, continuing along the lines of harmonizing all MS, proposes a new standard authorization procedure for conducting a clinical trial, where it is submitted through a new “single portal”, managed by the EC. The new authorization procedure can be summed up as two part procedure. In the first part, the sponsor submits a clinical trial application dossier (detailed in the regulation) to the intended MS (hereby referred as concerned MS) through the portal, and selects one of the intended MS as the “reporting MS”.

This reporting MS has to give a preliminary report in 6 days (whether or not the MS accepts being the reporting MS and if the trial falls into the new regulation). Afterwards, the reporting MS will carry out an evaluation of the clinical trial, focusing on details such as the expected therapeutic and public health benefits, risks for the patients and compliance with various requirements, taking into account considerations from the concerned MS. This assessment report of the trial has to be submitted to all concerned MS within 25 days for a normal clinical trial, 10 days if it’s a low intervention trial and 30 days if it’s for an ATMP.

Part II of the procedure is carried out by the concerned MS. It deals with intrinsic aspects of each MS (legislation, health culture, ethic concerns) and more technical details of the trial, like informed consent details, patient recruitment, site feasibility, trial investigator and others. Each individual MS assessment is communicated to the sponsor in 10 days from the validation date. If any deadline is exceeded, the trial will be approved as falling within the regulation. In some cases, a MS can opt out from the conclusions of the reporting MS.

Subsequent additions of new MS for a trial are also eased up in the new regulation. All they have to do is conduct an individual assessment, similar to the one conducted in part II (7) (12).


For evaluating a trial application, the current directive (1)  states that it must be conducted through each MS NCA and Ethic Committee. The new regulation however, gives the MS liberty in choosing what assessment bodies conduct the evaluation of the trial, as long as the MS safeguards that it is jointly carried out by a significant number of proper qualified professionals together with one patient and one person whose main area of interest is non-scientific.


Simplified rules for clinical trials of already authorized medicinal products

The regulation simplifies the requirements for proposing and conducting trials on already marketed drugs who pose few risks to the patients. These trials, dubbed “low intervention trials”, will have less regulatory requirements. Simplifications include short timelines for MS assessments (10 days) and sponsors aren’t obliged to provide damage compensations for clinical trial subjects (12) (7).


As previously mentioned, the regulation spares the sponsor of a low intervention clinical trial to pay indemnifications or insurance. In these cases, coverage is provided by the medical practitioner general insurance for example. For trials that require insurance, the 27 MS are obligated to set up a standard national indemnification mechanism for damages occurred to participants. It will be free of charge for studies that don’t intend to obtain data to support a MAA. This mechanism will be helpful to non-commercial sponsors when obtaining insurance coverage, something they have had difficulties since the introduction of obligatory insurance (1).

Shared responsibilities between sponsors – Co-Sponsorship

While the regulation deems that a single sponsor per clinical trial is preferable, it is aware that clinical trials are increasingly a multi MS activity, with multiple pharma companies and research institutions establishing networks. This creates difficulties when pinpointing a single sponsor, for practical or legal reasons.

This regulation introduces the concept of co-sponsorship, which allows sponsors to split responsibilities for a clinical trial among themselves. One sponsor must be designated as the main contact point with authorities. In the lack of such an agreement, all sponsors shall have full responsibility for a clinical trial.

Safety reporting

Rules for safety reporting, while still based in Directive 2001/20/EC, have been streamlined, with the most significant change regarding the annual safety reports. These have been modernized, and for drugs that are used according to their MAA, they don’t need to be submitted, as normal pharmacovigilance rules apply.



The regulation gives power to the European Commission to coordinate inspections between MS, and to coordinate the regulatory systems of non EU countries, as to ensure compliance with the new regulation and the ethical principles established in the Declaration of Helsinki.



Can the new regulation bring more stakeholders to invest in clinical research in Europe? Only the future can tell. But swift action is needed, to safeguard the well-being of clinical research in Europe.

  1. References:
    1. Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001, (2001).
    2. Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products, (1965).
    3. Reekie R. Conducting The Successful European Clinical Trial. Life Science Leader: VertMarkets Inc; 2011 [cited 2012 10-12-2012]; Available from:
    4. Comission directive 2005/20/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, (2005).
    5. Comission E. Responses to the Public consultation paper “Assessment of the functioning of the ‘Clinical Trials Directive’ 2001/20/EC. 2010 [cited 2012 10-12-2012]; Available from:
    6. Revision on the “Cilincal trials directive” 2001/20/EC summary of the replies to the public consultation on the “concept paper”, (2011).
    7. Department LWC. European Commission Proposes Overhaul of EU Clinical Trials Legislation. Client Alert. 2012.
    8. Lafarge-Sarkozy V, Olivier Lantrès PRL. Implementation of the Clinical Trials Directive by EU member states. Practical Law Company. 2007.
    9. Comission E. Executive summary of the impact assessment report on the revision of the “Clinical trials directive” 2001/20/EC. European Comission, 2012.
    10. Philippidis A. EC Eyes Summer Overhaul for Clinical Trial Rules to Improve Drug Development. GEN – Genetic Engineering & Biotechnology News2012 [cited 2012 10-12-2012]; Available from:
    11. medicine ticop. New EU clinical trial directive. 2012 [cited 2012 9-12-2012]; Available from:
    12. 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, (2012).
    13. EFPIA. “Reform of EU Clinical Trials Rules – Europe can’t afford to fail!”, says Richard Bergström. EFPIA2012 [cited 2012 10-12-2012]; Available from:

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