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
<!--:it-->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<!--:-->
19
Oct 21
The European Commission’s Medical Device Coordination Group (MDCG) endorsed a new guidance on the classification of medical devices
29
Sep 21
EU pharmaceutical strategy: today the Commission launched a public consultation on the revision of the EU general pharmaceuticals legislation (open until December 21, 2021)
4
Aug 21
Clinical Trials Regulation: EMA and European Commission confirmed that the Clinical Trials Information System (CTIS) will go-live on January 31, 2022
25
Jun 21
Clinical trials: EMA launches public consultation on draft guideline for using computerized systems and electronic data
9
Jun 21
The Medical Device Coordination Group endorsed new FAQ on the European Medical Device Nomenclature (EMDN), that aims at supporting the functioning of the European database on medical devices (EUDAMED)
25
May 21
The Italian Data Protection Authority published guidelines on the role of the Data Protection Officer in public entities: important news for hospitals and healthcare facilities
4
May 21
European Health Union: Commission publishes open public consultation on the European Health Data Space
4
May 21
<!--:it-->European Health Union: Commission publishes open public consultation on the European Health Data Space<!--:-->
22
Apr 21
Clinical Trial Regulation: Clinical trial EU Portal and Database, essential for the Clinical Trial Information System (CTIS), is now fully functional and on track to go live by 31 January 2022
19
Jan 21
Dematerialization of prescriptions: Ministerial Decree allowing e-prescriptions for drugs not reimbursed by the NHS has been published in the Italian Official Journal.
21
Dec 20
Telemedicine: Italian State-Regions Conference issues "National indications for the provision of telemedicine services" to implement telemedicine services in Italy
8
Oct 20
Ecommerce of medicinal products: according to the European Court of Justice, certain legislative restrictions imposed by the Member State where medicines are offered to public also apply to the online pharmacy established in another Member State
9
Jul 20
Italian Medicines Agency and medicines shortage: published Q&A for MAHs on notification of shortage and any temporary or permanent interruption in the marketing of medicines
