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.
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.
The National Coordination Centre for Ethics Committees published new draft agreements for conducting clinical trials on drugs and medical devices
EU Medical Device Coordination Group (MDCG) approves “Guidance” on the borderline between medical devices and medicinal products in order to support the uniform application of Regulation (EU) 2017/745 (MDR) across the European Union.
Repackaging, the spaces of parallel trade under EU regulations on QR Code, and anti-fraud seals
EU Regulation 2016/161, which since February 2019 requires the presence of anti-fraud seals on the packaging of medicines for human use, authorizes parallel importers to repackage only in the case of failure to ensure a tamper-prevention system “equivalent” to that used in the original packaging.
Council of State revokes previous judgements in a medical oxygen cartel case due to omission of decisive facts and arguments in the reasoning
On February 15, 2022, Italy’s Consiglio di Stato revoked its previous rulings confirming fines levied on five companies by the Italian Competition Authority for participating in a medical oxygen cartel, as it found manifest omission of facts and reasoning in the judgements, and asked the ICA to produce a set of documents acquired during the proceedings so it can re-examine the case.