EMA- European Network of Paediatric Research at the European Medicines Agency- Informed Consent for Paediatric Trials in Europe 2015 (revision 06 June 2023)

https://www.ema.europa.eu/en/documents/other/informed-consent-paediatric-clinical-trials-europe-2015_en.pdf

Italy

AIFA

https://www.aifa.gov.it/en/regolamento-europeo-sperimentazioni-cliniche

Ministry of Health

https://www.iss.it/farmaci

AIFA- National Observatory on Clinical Trials “OsSC”

https://www.aifa.gov.it/en/osservatorio-nazionale-sperimentazione-clinica

National Coordination Centre of Local Ethics Committees

https://www.aifa.gov.it/en/web/guest/centro-coordinamento-comitati-etici

Law n.3 of 11 Jan 2018 - Delegation to the Government in the field of clinical trials of medicinal products as well as provisions for the reorganisation of the health professions and for the health management of the Ministry of Health.

https://www.gazzettaufficiale.it/eli/id/2018/1/31/18G00019/sg

Decree no.52- 14 May 2019- Implementation of the Delegation for the reorganization and reform of the legislation on clinical trials of Medicinals products for Human Use

https://www.gazzettaufficiale.it/eli/id/2019/06/12/19G00059/SG

Decree of the Minister of Health of 26 January 2023, on the identification of 40 territorial ethics committees

https://www.gazzettaufficiale.it/eli/id/2023/02/07/23A00852/sg

Decree of the Minister of Health of 27 Jan 2023, Regulation of the transitional phase in accordance with Article 2, paragraph 15 of Law no. 3 of 11 January 2018, in relation to evaluation activities and how to interact between the Coordination Centre, Territorial Ethics Committees, and the Italian Medicines Agency

https://www.gazzettaufficiale.it/eli/id/2023/02/07/23A00851/sg

Decree of Ministry of Health 30 Jan 2023- On the definition of the criteria for the composition and functioning of territorial Ethics Committees

https://www.trovanorme.salute.gov.it/norme/dettaglioAtto?id=92078

Ministerial Decree of 30 January 2023 on "Determination of the single fee for clinical trials, of the attendance fee and reimbursement of expenses for participation in meetings of the National Coordination Centre of local ethics committees for clinical trials on medicinal products for human use and medical devices, of local ethics committees and of ethics committees of national relevance

https://www.gazzettaufficiale.it/eli/id/2023/02/07/23A00850/sg

MoH Circular 28 Feb 2023- To the National Coordination Center of Territorial Ethics Committees for Clinical Trials on medicines for human use and medical devices at AIFA

https://www.trovanorme.salute.gov.it/norme/renderNormsanPdf?anno=2023&codLeg=92498&parte=1%20&serie=null

National Ethics Committee for Clinical Trials of Public Research Bodies (EPR) and Other National Public Institutions

https://www.iss.it/en/comitato-etico

National Ethics Committee for Clinical Trials in the Pediatric Field,

https://www.aifa.gov.it/en/comitato-etico-per-le-sperimentazioni-cliniche-in-ambito-pediatrico

National Ethics Committee for the Trials of Advanced Therapies Medicinal Products (ATMPs)

https://www.aifa.gov.it/en/comitato-etico-per-le-sperimentazioni-cliniche-relative-alle-terapie-avanzate-atmp-

List of operative Ethics Committees

https://www.aifa.gov.it/documents/20142/1807486/2024.02.22_ELENCO_COMITATI_ETICI_SPER-CLINICA_IT.pdf

EU Licensing Portal

https://webgate.ec.europa.eu/frontoffice/welcome

EU Regulation 2021/821setting up a Union regime for the control of exports, brokering, technical assistance, transit and transfer of dual-use items (recast)

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02021R0821-20220107

EU-Guidance on Licensing Dual Use- Procedure to access the eLicesing system with two-factor authentication_Dec 2020

https://webgate.ec.europa.eu/frontoffice/resources/docs/eLi-2FA_Procedure-0.1.pdf

Ministry of Environment and Energy Security

https://www.mase.gov.it/pagina/biosicurezza-ogm-e-accesso-alle-risorse-genetiche

Ministry of Environment- Authorization procedure for the deliberate release into the environment of GMOs under Part B of the Directive 2001/18/EC

https://bch.mase.gov.it/index.php/it/?view=article&id=170&catid=15

Ministry of Health's Decree of 14 July 2009- Related to Insurance

https://www.gazzettaufficiale.it/eli/id/2009/09/14/09A10578/sg

https://www.gazzettaufficiale.it/eli/id/2023/02/07/23A00850/sg

Ministerial Decree 15 Nov 2011- Definition of minimum requirements for contract research organizations (CROs) in the field of clinical trials of medicines

https://www.gazzettaufficiale.it/eli/id/2012/01/14/12A00319/sg

AIFA Fees for authorization of clinical trials

https://www.aifa.gov.it/en/-/istruzioni-operative-in-merito-al-pagamento-della-tariffa-unica-per-le-sperimentazioni-cliniche

AIFA Payment of stamp duty on applications for authorization of clinical trials and substantial amendments.

https://www.aifa.gov.it/en/-/assolvimento-dell-imposta-di-bollo-sulle-domande-di-autorizzazione-di-sperimentazioni-cliniche-e-modifiche-sostanziali

Ethics Committee- Guideline on the collection of informed consent to participate in clinical trials_20 May 2022

https://www.aifa.gov.it/documents/20142/1619588/linee_indirizzo_centro_coordinamento_20_05_2022.pdf

Italian Data Protection Code- Legislative Decree no.101 of 10 Aug 2018 (effective from 19 Sept 2018)

https://www.gazzettaufficiale.it/atto/serie_generale/caricaDettaglioAtto/originario?atto.dataPubblicazioneGazzetta=2018-09-04&atto.codiceRedazionale=18G00129&elenco30giorni=true

Guide to the evaluation of the territorial ethics committees of the documents referred to Art 7 of the CTR 536/2014

https://www.aifa.gov.it/documents/20142/1783350/guida_predisposizione_documenti_CCN.pdf

TARIC- Taxation and Customs Union-