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
9
Feb 22
European Clinical Trials Regulation is now applicable: Recent updates
On January 31, 2022, EU Regulation 536/2014 on clinical trials of medicinal products for human use (“Clinical Trials Regulation” or “CTR”) finally went into effect more than seven years after its approval, but Italy is not yet ready for its application.
9
Feb 22
The new version of the Code of Ethics of the Italian association of pharmaceutical companies: Key developments
The Italian association of pharmaceutical companies (“Farmindustria”) released the new version of its Code of Ethics on January 19, 2022.
Some of the main changes concern i) hybrid events (art. 3.7 bis); ii) activities that pharmaceutical companies are allowed to carry out for non-prescribing HCPs (art. 3.25); iii) information provided to the public (art. 3.26); iv) interactions other than drug promotion (art. 3.28); and v) Patient Support Programs (article 4.7).
7
Feb 22
Digitization of Instructions for Use: the European Commission has endorsed a new Implementing Regulation on the use of electronic instructions for use (eIFUs) of medical devices
On December 14 2021, the European Commission adopted a new Implementing Regulation (EU) 2021/2226 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council relating to electronic instructions for use of medical devices.
7
Feb 22
New incentives from the Italian Government to promote telemedicine in pharmacies
As was recently demonstrated by the COVID-19 pandemic, the development of telemedicine has been an important tool in the containment of the disease.
4
Feb 22
Medical Devices Regulation: Note issued by the Ministry of Health to regulate the transition period
On November 12, 2021, the Ministry of Health published a note providing guidance on the provisions of Legislative Decree No. 46/1997 that shall still be considered applicable following the date of the application of Regulation (EU) 2017/745 on medical devices and the issuance of the legislative decrees envisaged by Article 15 of Delegation Law No. 53/2021.
