14
Sep 23
Drug advertising: New rules on advertising for over-the-counter and non-prescription medicines (OTC and SOP)
The Italian Ministry of Health updated the guidelines regulating the use of media to publish advertising messages regarding OTC and SOP: a good step in terms of streamlining and simplification of the applicable regulatory framework.
Thanks to Denise Moretti for collaborating on this article
14
Sep 23
The AI Act: What will the impact be on the medical device industry?
The European Parliament approved the “AI Act” (June 14, 2023), a proposal for a regulation providing a uniform legal framework for the use of artificial intelligence in the EU.
14
Sep 23
Digital Therapeutics: EFPIA recommendations for access to digital therapies in the EU
The European Federation of Pharmaceutical Manufacturers & Associations ("EFPIA") published a report on Improving access to digital therapeutics in Europe, aiming to promote a structured approach to the regulation of digital therapeutics ("DTx") on the European market.
13
Sep 23
Sunshine Act: Draft decree for the Sanità Trasparente electronic register published
Now available the draft decree and technical specifications envisaged by the Sunshine Act, establishing the structure and technical characteristics of the “Sanità Trasparente” electronic register, and the modalities for manufacturing companies to transmit notifications.
