4
Apr
Online sale of medicines without a prescription: The Court of Justice of the European Union approves intermediary sites
In its February 29, 2024 ruling, the Court of Justice of the European Union intervened on a major issue for the online medicine sales industry, paving the way for the entry of intermediary platforms.
19
Jan
Recent legislative news in the life sciences sector under the Budget Law
The so-called “Budget Law” for 2024 wields significant impact on the life sciences sector, and allocates to the healthcare sector EUR 3 billion for 2024, EUR 4 billion for 2025, and EUR 4.2 billion for 2026.
On July 21, 2023, the Italian Ministry of Health published new guidelines on health advertising of self-medication drugs (OTC) and non-prescription drugs (SOP), including advertising on new digital channels
5
Oct 22
Observational studies: From the November 30, 2021 Decree to the new document of the National Coordination Center for Ethics Committees
Pharmacological observational studies concern drugs prescribed according to an authorized therapeutic indication and based on normal clinical practice.
6
Jul 22
Clinical trial contracts: What the new NCCEC models provide
On May 31 of this year, the National Center for the Coordination of Ethics Committees updated its model drug and medical device trial contracts. They are the benchmark for regulating the relationships between sponsors, CROs, and research centers involved in clinical trials.
6
Jul 22
News on the reorganization of Ethics Committees: Latest updates
In the past few months great strides have been made to establish the national ethics committees envisaged by Law No. 3 of 2018 (the “Lorenzin Law”), which were supposed to be identified by the Ministry of Health within sixty days of the Lorenzin Law taking effect.
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