Regulation (EU) no 536/2014 on clinical trials on medicinal products for human use: An overview

Annali dell'Istituto Superiore di Sanita

Volumn 50, Issue 4, 2014, Pages 317-321

  Petrini, Carlo ^a  

^a ISTITUTO SUPERIORE DI SANITÀ   (Italy)

Author keywords

Europe; Human experimentation; Legislation

Indexed keywords

CLINICAL TRIAL (TOPIC); DRUG LEGISLATION; EUROPEAN UNION; HUMAN; LEGISLATION AND JURISPRUDENCE;

CLINICAL TRIALS AS TOPIC; EUROPEAN UNION; HUMANS; LEGISLATION, DRUG;

EID: 84922637293     PISSN: 00212571     EISSN: 23848553     Source Type: Journal    
DOI: 10.4415/ANN-14-04-04     Document Type: Article

References (13)

1. European Parliament, Council of the European Union. Regulation (EU) 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC. Official Journal of the European Union 27 May 2014;L158:1-76.
2. European Parliament and Council of the European Union. Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. Official Journal of the European Union 2001;L121:34-4.
3. Editorial. Clinical research in Europe-trials and tribulations. Lancet 2012;379(9828):1764. DOI: 10.1016/S0140-6736(12)60742-9
4. Kenter MJH, Cohen AF. Re-engineering the European Union Clinical Trials Directive. Lancet 2012;379(9828):1765-7. DOI: 10.1016/S0140-6736(12)60430-9
5. Cancer Research UK, Academy of Medical Sciences, Association of Medical Research Charities - AMRC, Arthritis Research UK, British Heart Foundation, Medical Research Council - United Kingdom et al. Revision of the EU Clinical Trials Directive. A joint statement from noncommercial research organisations in the UK. 2011. Available from: www.acmedsci.ac.uk/download.php?file=/images/project/Jointsta.pdf.
6. European Parliament, Council of the European Union. 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. COM/2012/0369 final. 2012/0192 (COD). 12 July 2012. Available from: http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A52012PC0369.
7. Jonsen AR, Veatch RM, LeRoy W. Source book in bioethics. A documentary history. Washington DC: Georgetown University Press; 1998.
8. Council of Europe. Convention for the Protection of Human Rights and Dignity of Human Being with Regards to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine. 4 April 1997. Available from: http://conventions.coe.int/treaty/en/treaties/html/164.htm.
9. European Parliament, Council of the European Union. Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data. Official Journal of the European Communities 23 November 1995;L281:31-50.
10. Chalmers I, Glasziou P, Godlee F. All trials must be registered and the results published. BMJ 2013;346:f105. DOI: 10.1136/bmj.f105.
11. World Medical Association. Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects. Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964 and amended by the: 29th WMA General Assembly, Tokyo, Japan, October 1975; 35th WMA General Assembly, Venice, Italy, October 1983; 41st WMA General Assembly, Hong Kong, September 1989; 48th WMA General Assembly, Somerset West, Republic of South Africa, October 1996; 52nd WMA General Assembly, Edinburgh, Scotland, October 2000; 53rd WMA General Assembly, Washington DC, USA, October 2002 (Note of Clarification added); 55th WMA General Assembly, Tokyo, Japan, October 2004 (Note of Clarification added); 59th WMA General Assembly, Seoul, Republic of Korea, October 2008; 64th WMA General Assembly, Fortaleza, Brazil, October 2013. Available from: http://www.wma.net/en/30publications/10policies/b3/.
12. Goldacre B, Godlee F, Heneghan C, Tovey D, Lehman R, Chalmers, Barbour V, Tracey B. Open letter: European Medicines Agency should remove barriers to access clinical trial data. BMJ 2014;348:g3768. DOI: 10.1136/bmj.g3768.
13. European Medicines Agency. Publication and access to clinical-trial data. EMA/240810/2013. Draft. 24 June 2013. Available from: www.ema.europa.eu/docs/en-GB/document-library/Other/2013/06/WC500144730.pdf.