The 2014 European Directive

The 2014 European Directive

Do you remember that last year, the European Directive of 2001 (2001/20 / EC) was repealed by the European regulation of 2014? This new directive, applicable to clinical trials on drugs for human use come into force in 2016. But in fact, what did it have more than the 2001 directive exactly?
In this article we offer you a summary of important points presented by this new European regulation, so that you’re ready for next year!

Ready for 2016 then?

Ready for 2016 then?

1. But first, a few dates…

As said before, the new European regulation was adopted on April 16, 2014 by the European Parliament. It was published a month later (May 27, 2014) in the Official Journal of the European Union (EU) and will come into force two years after its publication, that is, by May 2016.

As a reminder, this regulation only applies to clinical trials of drugs conducted in the EU (and not to non-interventional clinical trials; trials of products other than drugs: medical devices, cosmetics or out of Health Products “)

2. Its objectives

The main objective of this new regulation is to facilitate the trials taking place in several EU Member States, to make more attractive Biomedical Research in Europe and to restore its competitiveness. Here are the important points included in this new regulation

A. Harmonization of authorization application content for all Member States.

To simplify any clinical trial proceedings conducted in at least one Member State of the EU, a Clinical Trial Authorization Application will be filed by the promoter on the single IT portal (managed by the European Medicines Agency: EMD) and a Member State reporter shall be appointed.

Specifically, the single file will include two parts: one part will be jointly reviewed by the Member States concerned and the ethic part will be reviewed by the national ethic committee; all coordinated by the Member State reporter of which the national decision of unique authorization belongs. As regards the deadlines for review, you will find below a summary table of the ANSM (French National Agency For Medicine and Health Products).

Table of deadlines under the new EU regulation 2014 (source: ANSM)

Tableau-ANSM-Délais-Nouvelle-directive-2014

Thus through this portal, cooperation between Member States will be strengthened, but above all, the time saving will be considerable as it prevents the promoter having to present to several Member States largely identical information on the clinical trial: no more waiting times! No more lengthy paperwork!

To prepare for the implementation of this new regulation, the ANSM has set up a pilot phase involving a dozen of CPP and promoters. You can find more information about it here.

B. A clinical trial transparency

Transparency is one of the major points of this new regulation. Indeed, all the information relating to clinical trials will be consolidated in an EU database. However, exceptions relating to the publication of certain data, considered confidential should be noted: protection of personal data, protection of confidential commercial information (which may affect the competitiveness of the laboratory) … Information hiding will be done on a case by case basis subject to the explicit demands of the society.

More specifically, in a period of one year from the end of the study in all Member-States concerned, a summary of the results should be freely available to the public on this basis, and that, whatever the results ( positive or negative). This summary will be written so that it is understandable to the public.

For an optimum use, the database user interface will be available in all official EU languages.

C. Achievement of cross-border clinical trials

To boost European research, cross-border clinical trials may be conducted. This includes rare diseases for which it is difficult to group patients in a single country. Thus, at European level, patient samples will be larger, which will develop or improve treatment.

D. And if not, what else?

New terminologies and definitions will be incorporated in the regulation, as well as the concept of “risk” (yes, again!). More concretely, this new regulation will take into account the different risks posed by clinical trials (non-interventional trials are not concerned) to the participants. Thus, a new category of “low intervention” clinical trial will be created.

As for people called “vulnerable”, their protection is extended in the Regulation. Remember, the people considered “vulnerable” are “unable participants, minors, pregnant or nursing women, participants in trials in emergency situations.”

Similarly, the notion of obsolescence of the clinical trial authorization is integrated: If no participant has been included in the 2 years following approval of the trial, it will be considered invalid (note that the duration was reduced from 1 year in the previous directive, as stated in Article R1123-33 of the Code of Public Health).

To summarize, one of the key words of this new regulation of 2014 is Transparency of information to the public. In response, the EU single portal was created to enable Europe to access faster to innovation, but also to strengthen its attractiveness against its global competitors such as the US for example. With this new directive, a larger number of patients will benefit from innovative treatments, while ensuring their safety.

Sources:  Ansm.sante.fr

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Vanessa Montanari

Je suis Vanessa Montanari, attachée de recherche clinique, chef de projet et dirigeante, depuis 6 ans, de Pharmaspecific, ma propre société de prestation de services, en recherche clinique. www.pharmaspecific.fr

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