International agreements and arrangements for GMP clearance

The Australia- European Union (EU) MRA covers multiple industry sectors. The agreement allows us to mutually recognise the outcomes of GMP inspections conducted by the relevant regulatory authority within their country. This agreement also extends to Norway, Iceland, and Liechtenstein. 

How this applies to GMP Clearance

If you intend to obtain GMP clearance within the scope of the agreement, use:

• the MRA pathway if the regulatory authority has inspected a manufacturer within its own borders
• the Compliance Verification (CV) pathway when the regulatory authority has inspected a manufacturer outside its own borders

As of 1 January 2021, the UK ceased to be a member state of the EU and therefore the EC MRA is no longer applied. A new MRA between Australia and UK is now in force, which includes the mutual recognition arrangements under the EC MRA, subject to the provisions of the Australia-UK agreement.

How this applies to GMP Clearance

If you intend to obtain GMP clearance within the scope of the agreement, use:

• the MRA pathway if the regulatory authority has inspected a manufacturer within its own borders
• the CV pathway when the regulatory authority has inspected a manufacturer outside its own borders

Australia has an MRA with Canada specifically for mutual recognition of medicinal product GMP inspections and certification.

How this applies to GMP Clearance

If you intend to obtain GMP clearance within the scope of the agreement, use:

• the MRA pathway if the regulatory authority has inspected a manufacturer within its own borders
• the CV pathway when the regulatory authority has inspected a manufacturer outside its own borders

Where using Health Canada’s Exit Notice for the CV pathway, a liaison fee is applicable to obtain further evidence from Health Canada.

The MRA between Australia and Singapore covers three industry sectors, including GMP inspections for medicinal products. The agreement allows us to mutually recognise the outcomes of GMP inspections of medicinal product manufacturers within each other’s country.

How this applies to GMP Clearance

If you intend to obtain GMP clearance within the scope of the agreement, use:

• the MRA pathway if the regulatory authority has inspected a manufacturer within its own borders

We have arrangements with the Medicines and Medical Device Safety Authority (Medsafe) of New Zealand to exchange information relating to medicine manufacturers and mutually recognise GMP inspection outcomes within each other’s country.

How this applies to GMP Clearance

If you intend to obtain GMP Clearance within the scope of the agreement, use:

• the MRA pathway if the regulatory authority has inspected a manufacturer within its own borders

In addition to the existing mutual recognition agreement between Australia and Canada, TGA has an MoU with Health Canada for strengthening cooperation and increasing reliance on each other’s extra-jurisdictional medicinal product GMP inspections and certification.

How this applies to GMP Clearance

How this applies to GMP Clearance

If you intend to obtain GMP clearance within the scope of the agreement, use:

• the CV pathway when the regulatory authority has inspected a manufacturer outside its own borders

Where using Health Canada’s Exit Notice for the CV pathway, a liaison fee is applicable to obtain evidence from Health Canada. Certain requirements are only applicable for:

• Active Pharmaceutical Ingredient (API) manufacturers
• Contract testing laboratories
• Contract sterilisers

The MoU between the Swiss Agency for Therapeutic Products (Swissmedic) and the TGA allows for the exchange of information and documentation relating to facilities manufacturing or testing therapeutic goods.

How this applies to GMP Clearance

If you intend to obtain GMP clearance within the scope of the agreement, use:

• the MRA pathway if the regulatory authority has inspected a manufacturer within its own borders
• the CV pathway when the regulatory authority has inspected a manufacturer outside its own borders

We have a cooperation agreement with the US FDA to share information on manufacturers for medicinal products. This allows us to consider the outcome of their GMP inspections for GMP Clearance.

How this applies to GMP Clearance

If you intend to obtain GMP clearance within the scope of the agreement, use:

• the CV pathway where US FDA has inspected within or outside its own borders

The EDQM inspects manufacturers of active pharmaceutical ingredients (APIs) and excipients outside the European Union (EU), based on its own program. In most cases this involves the participation of an EU regulatory authority. The EU regulatory authority issues a GMP certificate following a successful on-site inspection and uploads it to the EudraGMDP database.

We have a cooperative agreement with EDQM to share information relating to the regulation of therapeutic goods, including manufacture of API and excipients for therapeutic goods. This allows us to consider the outcome of their GMP inspections for GMP Clearance.

How this applies to GMP Clearance

If you intend to obtain GMP clearance within the scope of the agreement, use:

• the CV pathway when EDQM has inspected a manufacturer outside the EU with an EU member state

Where using EDQM inspection, we will only accept the GMP certificate issued by an EU regulatory authority listed above, together with the corresponding EDQM inspection report.