The MHRA is retiring the eSUSAR website in favour for Individual Case Safety Reports (ICSR) Submissions, providing users “a more robust, stringent, and transparent way of expediting suspected unexpected serious adverse drug reactions (SUSARs) from Clinical Trials of Investigational Medicinal Products” (IMPs). The eSUSAR website used for the submission of …
Health Canada has implemented amendments to labelling requirements under the Natural Health Products Regulations (NHPR) as a result of challenges identified in recent years surrounding the widespread use of Natural Health Products (NHPs) by Canadians. The amendments imposing revised labelling standards are subject to a three year transition period and …
On 20 Jun 2022, the TITCK published the guidelines to Good Pharmacovigilance (IFU) Module X and Module Xi – pre marketing Benefit/Risk assessment and Post marketing benefit/Risk assessment respectively. New Updates: Module X: Pre-marketing benefit/risk assessment Guideline The acceptable benefits and risks should be briefly summarized along with the background …