Planning a Health Canada PRCI Compliant Submission
How to set yourself up for a successful Health Canada PRCI submission
How to set yourself up for a successful Health Canada PRCI submission
Background In 2018, the Food and Drug Administration (FDA) launched a pilot to test the capability of publicly posting summaries of the safety and efficacy information that is used to make drug approval decisions. This followed suit with the European Medicine Agency’s (EMA) Policy 0070 that launched in 2015 and Health Canada’s (HC) Clinical Information … Continued