2
Feb 23
Register of Observational Studies: AIFA announces activation as of January 31, 2023
In a recent press release published on its website, the AIFA announced that as of January 31 the Register of Observational Studies (“RSO”) will be active and accessible through the AIFA online services portal — as is already the case for interventional pharmacological studies and the related OsSC portal.
2
Feb 23
The CJEU rules on the legality of a national law prohibiting medicinal product advertising to the general public that uses price to induce consumers to purchase
In the recent judgment of December 22, 2022 in Case C-530/20, the CJEU ruled that European law and in particular Directive 2001/83/EC are compatible with a national law that prohibits advertising even unidentified medicinal products if the advertising message encourages the purchase of the products by leveraging pricing, promotional offers, discounts, and combined sales with other products, medicinal or otherwise (including at discounted prices).
2
Feb 23
New decrees for the reorganization of ethics committees have been signed: The last fundamental steps for operation of the CTR in Italy
On January 30, the Ministry of Health finally signed four ministerial decrees that mark fundamental turning points in the construction of a regulatory framework for the European Clinical Trials Regulation (“CTR”) to become operations.
31
Jan 23
How Covid changed telemedicine in Italy: Current status and next steps
In Italy, the Covid-19 pandemic rapidly accelerated implementation of telemedicine, which then was named one of the top priorities in the National Recovery and Resilience Plan. Mission No. 6 of that plan (Health) earmarks EUR 1 billion for the development of telemedicine to provide healthcare locally.
