Oct 31, 2022 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...
Oct 25, 2022 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...
Oct 10, 2022 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”...
Oct 07, 2022 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...