Italy

Governing Agencies and Ethics Review Structure

Useful Documents and Points to Consider – Investigators

Ministerial Decree 21 (2007)- Directions for submitting the request for Authorisation of a Clinical Trial on a Medicinal Products for Human Use to the Competent Authority for Communicating Substantial Amendments for Declaring the End of the Trial and for the Request of an Opinion to the Ethics Committee

  • Ministerial Decree (2008)

Definition of the Minimum Requirements that Contract Research Organizations (CROs) Shall Satisfy in order to work within Clinical Trials on Medicinal Products

  • Ministerial Decree of November 6 2007: “Transposition of Directive 2005/28/EC relating to principles and guidelines for good clinical practice for medicines in experimental phase for human use, and requirements for the authorization to produce and to import these medicines”
  • Ministerial Decree of May 12, 2006: “Minimum requirements for the institution, organization and functioning of Ethical Committee for clinical trials with medicines”
  • Ministerial Decree of December 17, 2004: “Prescriptions and conditions of a general nature referring to the conduct of clinical trials of medicines with special reference to those designed to enhance clinical practice as an integral part of health and medical care.”
  • Legislative Decree no.211 of June 24, 2003: “Transposition of Directive 2001/20/EC relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for clinical use”.
  • Decree of the President of the Republic of September 21, 2001: “Regulations to simplify the Procedures and to Verify and Check New Systems and Experimental Therapeutic Protocols”.
  • Ministerial Decree of May 10, 2001: “Controlled clinical trials conducted by General Practitioners and Paediatricians”.
  • Ministerial Circular no. 15 of 5 October 2000: “Updating of the ministerial circular n. 8 of 10 July 1997 relating clinical trials with medicines”.
  • Decree of the Director General of the Department of medicines evaluation and pharmacovigilance of the Ministry of Health, of May 25, 2000: “Electronic transmission of data concerning clinical trials”.
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  • Ministerial Decree of March 18, 1998: “Procedure for the exemption from assessment on medicines used in clinical trials”.
  • Ministerial Decree of 15 July 1997: “Transposition of guidelines of the European Union in good clinical practice for the conduction of clinical trials with medicines”.
  • Prime Minister’s Decree of March 28, 1990 establishing the National Bioethics Committee.
  • Ministerial Decree of 14 July 2009: “Minimum requirements for insurance policies which safeguard participants to clinical trials of medicinal products”.

Local Research Institutions