GMP Clearance applications using Health Canada evidence

Health Canada (HC) and the Therapeutic Goods Administration (TGA) have an existing Mutual Recognition Agreement (MRA) on Conformity Assessment in Relation to Medicines Good Manufacturing Practice Inspection and Certification between the Government of Canada and the Government of Australia. Under this MRA, Australian sponsors who source medicines from a manufacturing site located in Canada, can use a HC issued 'Inspection Exit Notice' in lieu of a GMP Certificate as supporting GMP evidence for their GMP Clearance application.

However, when HC inspect outside their borders, and the MRA no longer applies, an Inspection Exit Notice on its own does not meet the current evidence requirements for a GMP Certificate and an inspection report for the GMP Clearance Compliance Verification (CV) pathway because it does not contain sufficient information about the on-site inspection as outlined in the inspection report requirements in the GMP Clearance Guidance.

TGA have been actively collaborating with HC to explore options for utilising their evidence for the Compliance Verification (CV) pathway. In order to enable sponsors to use the HC 'exit notice' in support of their CV GMP Clearance application, we will be required to liaise with HC to obtain further evidence related to the inspection activities performed at the manufacturing site. The additional information is critical for us to be able to adequately assess the coverage of the inspection to allow us to make a determination on the GMP Clearance.

Given the additional liaising requirement for the TGA to obtain further evidence from HC, the additional liaison fee (Obtaining evidence from an overseas regulatory authority) will be applicable to all CV clearance applications submitted using HC 'exit notices', including all submitted CV clearance applications that are currently in progress.