20
Mar
Today, Regulation (EU) 2023/607 extending the transitional provisions for the placing on the market and putting into service of certain medical devices and in vitro diagnostic medical devices entered into force following publication on EU's Official Journal
31
Jan
Clinical trials: Ministry of Health signed off on decrees that (i) reorganize ethics committees and coordinate their activities, (ii) determine the single tariff for the authorization procedure and (iii) regulate the transitional period for evaluation activities
19
Dec 22
On 13 December 2022, EMA, European Commission and HMA jointly adopted a recommendation paper on the introduction of decentralised elements in the conduct of Clinical Trials in the EU/EEA
21
Sep 22
Payback for medical devices: Decree quantifying the exceeding of the expenditure ceiling for medical devices at national and regional level for the years 2015, 2016, 2017 and 2018 published in the Official Gazette
1
Sep 22
The 2021 annual law for market and competition addressing, as to the healthcare sector, reimbursement of drugs, intermediate distribution, patent linkage and institutional accreditation of private healthcare facilities entered into force on 27 August
19
Jul 22
Guidelines for the implementation of the Electronic Health Record (EHR) to ensure dissemination, uniformity and accessibility of the EHR at national level now published in the Official Gazette
6
Jun 22
The National Coordination Centre for Ethics Committees published new draft agreements for conducting clinical trials on drugs and medical devices
27
Apr 22
EU Medical Device Coordination Group (MDCG) approves “Guidance” on the borderline between medical devices and medicinal products in order to support the uniform application of Regulation (EU) 2017/745 (MDR) across the European Union.
5
Apr 22
Electronic prescriptions: the current modalities of transmission from doctors to patients and from patients to pharmacies are extended until 31st December 2022
24
Mar 22
EU Medical Device Coordination Group (MDCG) approves “Guidance” on appropriate surveillance of devices covered by certificates according to the MD Directives, under the transitional provisions of Article 120(3) of the MDR.
21
Mar 22
Published Decree of Health Ministry identifying the ethics committees of national significance for clinical trials of medicinal products and medical devices
23
Feb 22
Published Decree of Health Ministry providing measures to enhance no-profit clinical trials and to regulate transfers of data and results of no-profit studies for registration purposes
2
Feb 22
Clinical Trials Regulation - European Commission updates the Questions and Answers Document
1
Feb 22
Clinical trials Regulation: AIFA endorsed a proposal for the temporary administration of trials pursuant to the CTR, pending the publication and full implementation of the ministerial decrees on the reorganization of ethics committees and single tariff
27
Jan 22
The Regulation amending Regulation (EU) 2017/746 as regards new transitional provisions for certain IVDs and the deferred application of conditions for in-house devices has now been published
26
Jan 22
The Italian association of pharmaceutical companies published a new version of the Code of Professional Conduct, regulating relations between pharmaceutical companies and their relations with the scientific and healthcare sectors
13
Dec 21
The European Commission’s Medical Device Coordination Group (MDCG) endorsed a new guidance on the operational and practical implementation of Articles 13&14 and other related obligations for importers and distributors under MDR and IVDR Regulations
27
Oct 21
The European Commission’s Medical Device Coordination Group (MDCG) endorsed a new guidance on the applicability of MDR requirements to 'legacy devices' and 'old' devices
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