References
- Woods K. Implementing the european Clinical Trials Directive. BMJ328, 240–241 (2004).
- Hoey R. The EU Clinical Trials Directive: 3 years on. Lancet369, 1777–1778 (2007).
- Hemminki A, Kellokumpu-Lehtinen P. Harmful impact of EU Clinical Trials Directive. BMJ332, 501–502 (2006).
- Sheard L, Tompkins CNE, Wright NMJ, Adams CE. Non-commercial clinical trials of a medicinal product: can they survive the current process of research approvals in the UK? J. Med. Ethics32, 430–43 (2006).
- Berendt L, Håkansson C, Bach KF et al. Effect of European Clinical Trials Directive on academic drug trials in Denmark: retrospective study of applications to the Danish Medicines Agency 1993–2006. BMJ336, 33–35 (2008).
Websites
- 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 http://ec.europa.eu/enterprise/sectors/pharmaceuticals/files/eudralex/vol-1/dir_2001_20/dir_2001_20_en.pdf
- European Commission. European Medicines Agency conference on the operation of the Clinical Trials Directive (Directive 2001/20/EC) and perspectives for the future, 3 October 2007. EMA report of the proceedings of the conference on the operation of the Directive www.ema.europa.eu/pdfs/conferenceflyers/clinicaltrials/report.pdf
- European Science Foundation Forward Look report. Investigator-driven clinical trials, 10 Mar 2009 Link
- European Commission high level group of independent stakeholders on administrative burdens. Opinion of the high level group, priority area pharmaceutical legislation, 5 March 2009 http://ec.europa.eu/enterprise/policies/better-regulation/files/hlg_opinion_pharma_050309_en.pdf
- The Medicines for Human Use (Clinical Trials) Regulations 2004, (SI 2004/1031) www.opsi.gov.uk/si/si2004/20041031.htm
- EU legislation, EudraLex (Volume 10), clinical trials guidelines. Dates of revision of guidelines and new guidelines are shown on the EudraLex Volume 10 webpage http://ec.europa.eu/enterprise/sectors/pharmaceuticals/documents/eudralex/vol-10/index_en.htm
- The European Medicines Evaluation Agency (EMEA) has recently changed its name to the European Medicines Agency (EMA) www.ema.europa.eu/
- European Forum for Good Clinical Practice report. Impact on Clinical Research of European Legislation, February 2009 www.efgcp.be/downloads/icrel_docs/Final_report_ICREL.pdf
- European Medicines Agency implementation of the new EU Pharmaceutical Legislation – telematics projects. Description of the set of databases and electronic tools that support the European Medicines Regulatory Network www.ema.europa.eu/htms/general/direct/legislation/eutelematics.htm
- Guidance document for a Voluntary Harmonization Procedure (VHP) for the assessment of multinational clinical trial applications www.hma.eu/uploads/media/VHP_version_2_March_2010.pdf
- Clinical trial application (CTA) assessment in Member States: who assesses what? www.hma.eu/uploads/media/Assessment_in_MS_public_dec_08__2_B.pdf
- Interactive policy making: online consultations http://ec.europa.eu/yourvoice/ipm/index_en.htm
- Detailed guidance for the request for authorization 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. (Revision 2 October 2005) http://ec.europa.eu/enterprise/sectors/pharmaceuticals/files/eudralex/vol-10/11_ca_14–2005_en.pdf
- Detailed guidance on the collection, verification and presentation of adverse reaction reports arising from clinical trials on medicinal products for human use http://ec.europa.eu/enterprise/sectors/pharmaceuticals/files/eudralex/vol-10/21_susar_rev2_2006_04_11_en.pdf
- Regulation (EC) no 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending regulation (EEC) no 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and regulation (EC) no 726/2004. Official Journal L 378, 27.12.2006 1–9 http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2006:378:0001:0019:EN:PDF
- Regulation (EC) no 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and regulation (EC) no 726/2004. Official Journal L 324, 10/12/2007, 121–137 http://ec.europa.eu/enterprise/sectors/pharmaceuticals/files/eudralex/vol-1/reg_2007_1394/reg_2007_1394_en.pdf
- Commission communication 10 December 2008. ‘Safe, innovative and accessible medicines: a renewed vision for the pharmaceutical sector’. COM (2008) 668 final http://eur-lex.europa.eu/LexUriServ/LexUriServ.o?uri=COM:2008:0666:FIN:en:PDF
- Assessment of the Functioning of the Clinical Trials Directive 2001/20/EC–public consultation paper ENTR/F/2/SF D(2009) 32674 http://ec.europa.eu/enterprise/sectors/pharmaceuticals/files/clinicaltrials/docs/2009_10_09_public-consultation-paper.pdf
- Legislative proposal on Regulation/Directive amending the Clinical Trials Directive 2001/20/EC: initial impact assessment and planning of further work. Version 2, 23 March 2010 http://ec.europa.eu/governance/impact/planned_ia/docs/47_sanco_clinical_trials_directive_en.pdf
- Responses to the public consultation paper – Assessment of the functioning of the Clinical Trials Directive 2001/20/EC http://ec.europa.eu/enterprise/sectors/pharmaceuticals/human-use/clinical-trials/developments/responses_2010–02_en.htm
- Assessment of the functioning of the Clinical Trials Directive 2001/20/EC – summary of responses to the public consultation paper. SANCO/C/8/SF/dn D(2010) 380240 30 March 2010 http://ec.europa.eu/enterprise/sectors/pharmaceuticals/files/clinicaltrials/2010_03_30summary_responses.pdf
- UK response to the Commission’s consultation on review of the Clinical Trials Directive www.mhra.gov.uk/Howweregulate/Medicines/Medicinesregulatorynews/CON068367
- MRC-MHRA (Medicines and Healthcare Products Regulatory Agency) Risk–benefit analyses to support decision-making www.mrc.ac.uk/consumption/groups/public/documents/content/mrc006364.pdf
- Medicines for human use (clinical trials) regulations 2004. Memorandum of Understanding between MHRA, COREC and GTAC. (Memorandum of understanding between the UK national competent authority [Medicines and Healthcare products Regulatory Agency], the national body representing UK ethics committees [National Research Ethics Service] and the UK ethics committee for gene therapy clinical trials [Gene Therapy Advisory Committee] setting out the responsibilities for each body in the authorization of a clinical trial of a medicine) www.mhra.gov.uk/home/idcplg?IdcService=GET_FILE&dDocName=CON2025075&RevisionSelectionMethod=Latest
- National Research Ethics Service: Guidance www.nres.npsa.nhs.uk/rec-community/guidance/