Normativa

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Normativa

Ministerial Decree on July 14, 2009

Minimum requirements for insurance policies to protect those that participate in clinical trials.

AIFA Determination on December 23, 2008

Definitions of the minimum requirements for Contract Research Organizations (CROs) as part of clinical trials in accordance with Article 7, paragraphs 5 and 6, and Article 8 of the Ministerial Decree 31 March 2008.

Ministerial Decree on November 7, 2008

Changes and additions to the Decrees of 19 March 2008, 8 May 2003 and 12 May 2006.

Ministerial Decree on March 31, 2008

Definitions of minimum requirements for Contract Research Organizations (CROs) as part of clinical trials.

Corrigenda to the AIFA determination on March 20, 2008

Press about the AIFA determination on March 20, 2008: "Guidelines for the Classification and conduct of observational studies on drugs."

AIFA Determination on March 20, 2008

"Guidelines for the Classification and conduct of observational studies on drugs."

AIFA Circular on March 20, 2008

"Guidelines for the Classification and conduct of observational studies on drugs."

Ministerial Decree on December 21,2007

How to forward the authorization request to the competent authority for the communication of substantial amendments and declaration of end of the clinical trial and to ask an opinion to the ethic committee.

Legislative Decree n. 200 on November 6, 2007

Implementation of Directive 2005/28/EC laying principles and detailed guidelines for good clinical practice related to investigational medicinal products for human use, for manufacturing or importation of these products.

Ministerial Decree on May 12, 2006

Minimum requirements for establishment, organization and operation of ethics committees for clinical trials.

Legislative Decree on December 17, 2004

General requirements and conditions related to the implementation of clinical trials.

Legislative Decree n. 211 on June 24, 2003

Implementation of Directive 2001/20/EC about the implementation of good clinical practice in clinical trials of drugs for clinical use.

Ministerial Decree on May 8, 2003

Therapeutic use of drugs under clinical trials.

Ministerial Circular n. 6 on September 2, 2002

Activities of ethics committees established under Ministerial Decree of 18 March 1998.

Decree of the President of the Health Superior Institute on April 26, 2002

Verification about the composition and safety of new drugs before clinical trials on humans. Identification of the documentation submitted by the Health Superior Institute.

Decree of the Republic President n. 439 on September 21, 2001

Rules to simplify procedures for the verification and monitoring of new systems and experimental treatment protocols.

Ministerial Decree on May 30, 2001

Findings on compliance inspection of good clinical practice.

Ministerial Decree on May 10, 2001

Controlled clinical trials in general medicine and pediatrics of free choice.

Ministerial Decree on December 28, 2000

Measures aimed to minimize the risk of transmission to humans, through drugs, of agents that cause the animal spongiform encephalopathy.

Managerial Decree on May 25, 2000

Electronical transmission of data regarding the clinical trials.

Decree of the Ministry of Health on January 3, 2000

Findings on compliance inspection of good clinical practice (Official Gazette N. 53, 4-3-2000).

Ministerial Decree on November 23, 1999

Determination and composition of functions of the National Ethic Committee for clinical trials, according to the Legislative Decree N. 229 of June 19, 1999.

Ministerial Circular n. 16 on October 12, 1999

Irregularities in the authorization of procedures and in the execution of clinical trials.

Ministerial Decree on May 13, 1999

Determination and composition of functions of the National Ethics Committee for clinical trials, according to the Legislative Decree No 229 of June 19, 1999.

Ministerial Circular n. 6 on April 8, 1999

Explanations on the Ministerial Decrees of March 18, 1998 and March 19, 1998 published on Official n. 123 of May 28, 1998.

Ministerial Decree on January 20, 1999

Measures on the marketing and on clinical trials of medicinal products containing materials of bovine origin.

Ministerial Decree on October 7, 1998

Additions to the Decree of March 19, 1998 (published in the Official Gazette No. 274 of November 23, 1998).

Ministerial Decree on September 15, 1998

Addition to the Decree of March 18, 1998.

Ministerial Decree on March 19, 1998

Ministerial Decree regarding criteria about the qualification of centers for clinical trials.

Ministerial Decree on March 18, 1998

Ministerial Decree of March 18, 1998 regarding the Guidelines for the establishment and operation of ethics committees (published on Official Gazette on May 28, 1998).

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