Abstract

Currently, the Canadian regulatory authority for medicinal products, Health Canada (HC), does not have a dedicated quality overall summary (QoS) template for the following investigational medicinal products (IMPs): biopharmaceuticals, advanced therapy medicinal products (ATMPs), genetically modified organisms (GMOs) and vaccines, hereinafter referred to as ‘biological IMPs’.

In addition, sponsors are often confused by the HC and Environment and Climate Change Canada (ECCC) new substances notification (NSN) requirements for IMPs containing a drug substance (DS) classed as either a chemical or biochemical.

The aim of this article is to provide key awareness and guidance on QOS requirements for biopharmaceuticals, ATMPs, GMOs, vaccines and NSN requirements with respect to chemicals and biochemicals that will be evaluated in a clinical trial (CT).