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24 Mart 2014

Avrupa Komisyonu 2001/20 EC direktifini degiştiriyor.. SocialDoctors İçerisinde Paylaş

Directive 2001/20/EC: Clinical Trials

The Commission has published a proposal for a Clinical Trials Regulation: COM(2012) 369 (IDRAC 146705) (Jul-2012). This will repeal Directive 2001/20/EC (IDRAC 28709). Replacing the Directive with a Regulation will provide a single regulatory framework and facilitate cooperation between Member States.


New features include:

· Revised authorisation procedure involving:

- a single submission (for regulatory and ethical review) to the intended Member States via an EU Portal

- joint assessment between Member States of trials involving more than one Member State; ethics committees will continue to operate on a national basis

- one joint decision (regulatory and ethical) from each Member State

· New concept of a ?low-intervention clinical trial?: using authorised products under a protocol which represents minimal additional risk to subject safety compared to normal clinical practice.

These trials would be subject to reduced requirements;

· New provision relating to co-sponsorship;

· Clarification of requirements for auxiliary medicinal products and radiopharmaceuticals used as diagnostic investigational medicinal products;

· EU Portal and EU database to be established for receiving information relating to submissions, including notification of end of recruitment;

· Clarified safety reporting requirements for investigators;

· Possibility of system inspections of third country regulatory systems with respect to GCP.


Further information is given in the Regulatory Summary on the Initiation and Conduct of Clinical Trials (IDRAC 21417).



The stages to date are as follows:

Ordinary Legislative ( Co-decision) procedure (IDRAC 12383):

Proposed Regulation: COM(2012) 369 (IDRAC 146705) Jul-2012

Economic and Social Committee opinion (IDRAC 156630) (Dec-2012) (Note 4)

Report adopted by Parliamentary Committee: A7-0208/2013 (IDRAC 166050) Jun-2013

Discussed by Council: 3247th Council meeting (Employment, Social Policy, Health and Consumer Affairs) Jun-2013 (Note 5)

Council announcement (IDRAC 174013) on compromise agreement [Council document 17866/13 (IDRAC 174513) (Dec-2013)] with Parliament and Commission, Dec-2013 (Note 5).


Current position:

The regulation as given in the above compromise agreement is undergoing technical finalisation after which it will be voted on in Parliament.


Estimated forecast:

Parliament Plenary sitting: Apr-2014.

The Regulation is expected to be published and enter into force in 2014. It will apply 6 months after the publication concerning the functionality of the EU Portal and EU database, but in any event not earlier than two years after the date of publication of the regulation (so it will not apply before 2016 if the regulation is published in 2014). Transition periods will apply.


Note 4: The proposed legislation has also been considered by the European Data Protection Supervisor, whose opinion, given in Council document 6670/13 (Feb-2013), discusses aspects relating to personal data including the processing and storage of personal health data. Document available on Council of European Union?s web-site:http://www.consilium.europa.eu/.


Note 5: Jun-2013 debate based on Council document 10452/13 (Jun-2013). The press release (11081/13) of the meeting notes that a number of areas need further discussion including the shortening of time-limits for the authorisation of clinical trials, the ethical evaluation of clinical trials, the protection of volunteers and the damage compensation and indemnification mechanism. Updated information is given in Council documents 7816/5/13 (Jul- 2013), 15245/13 (Oct-2013) and 15720/13 (Dec-2013). Documents available on Council of European Union?s web-site:http://www.consilium.europa.eu/.

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