10/31/2022 4:29:00 PM Update on the UK’s future medical device regulations: Extended timelines By Pieter Erasmus The UK’s Medicines & Healthcare products Regulatory Agency (MHRA) has recently announced the introduction of a 12-month extension to the...
10/25/2022 5:47:00 PM Blood, cells and tissues: regulatory change is coming By Phillipus Putter Approximately twenty years ago, the regulation of Substances of Human Origin (“SHO”) in Europe was reshaped by the introduction of the...
10/10/2022 10:26:00 AM Publication of the English version of the new French Clinical Trial Agreement templates By Johanna Harelimana Alexandre Vuchot Nour Saab The French legislator recently updated the French clinical trial agreement template also called “clinical trial sole agreement”...
10/7/2022 3:34:00 PM The Activation of Payback on Medical Devices By Simone Cadeddu Mauro Turrini The Italian Ministry of Health, in a Decree dated 6 July 2022, certified the overrun of the expenditure ceiling for medical devices in...