The TGA has various international agreements and arrangements with other countries and regulatory authorities. Some of these allow us to rely on each other’s Good Manufacturing Practice (GMP) inspection programs. The scope of these agreements, the regulatory authorities covered and how they can be used in applications for GMP Clearances from the TGA is outlined below.
NOTE: before we can accept evidence from another regulatory authority as part of a GMP Clearance application, we assess that regulatory authority’s GMP program and confirm its equivalency to Australia’s GMP requirements.
For more information on the GMP Clearance process, please refer to the GMP Clearance guidance.
Mutual Recognition Agreements
Mutual recognition agreements (MRA) are internationally binding agreements between countries to facilitate trade and market access. They can allow mutual recognition of GMP inspection outcomes of medicine manufacturers within the borders of each partner country.
We have MRAs with:
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.
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Regulatory authority |
Austria |
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Belgium |
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Croatia |
Agency for Medicinal Products and Medical Devices of Croatia (HALMED) |
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Cyprus |
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Czech Republic |
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Denmark |
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Estonia |
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Finland |
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France |
National Agency for the Safety of Medicine and Health Products (ANSM) |
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Germany |
Federal Institute for Drugs and Medical Devices (BfArm) Note: GMP inspections in Germany are shared between the central authority, Central Authority of the Laender for Health Protection regarding Medicinal Products and Medical Devices (ZLG) and the German regional authorities. |
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Greece |
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Hungary |
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Iceland |
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Ireland |
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Italy |
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Latvia |
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Liechtenstein |
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Lithuania |
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Luxembourg |
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Malta |
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Netherlands |
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Norway |
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Portugal |
National Authority of Medicines and Health Products (Infarmed) |
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Poland |
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Romania |
National Agency for Medicines and Medical Devices of Romania (NAMMDR) |
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Slovak Republic |
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Slovenia |
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Spain
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Spanish Agency for Medicines and Health Products (AEMPS) Note: GMP inspections in Spain are shared between the central authority, Spanish Agency for Medicines and Medicinal Devices (AEMPS) and the Spanish regional authorities. |
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Sweden |
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Agreements / arrangements |
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Scope |
Covers ‘Human medicinal products’ including:
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Exclusions |
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Applicable territory |
Inspections within the countries listed above. |
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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.
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Regulatory authority |
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Agreements / arrangements |
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Scope |
Covers ‘Human medicinal products’ including:
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Exclusions |
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Applicable territory |
Inspections within the UK |
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.
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Regulatory authority |
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Agreements / arrangements |
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Scope |
Covers ‘medicinal products’ including:
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Exclusions |
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Applicable territory |
Inspections within Canada |
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.
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Regulatory authority |
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Agreements / arrangements |
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Scope |
Covers ‘Human medicinal products’ including:
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Exclusions |
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Applicable territory |
Inspections within Singapore |
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.
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Regulatory authority |
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Agreements / arrangements
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Scope |
Covers ‘medicinal products’ including:
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Exclusions |
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Applicable territory |
Inspections within New Zealand |
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
Memorandums of Understanding
Memorandums of Understanding (MoU) are non-binding agreements to establish collaborative goals and formalise arrangements. These MoUs allow the exchange of information in relation to GMP inspections of medicine manufacturers.
We currently have an MoU with:
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.
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Regulatory authority |
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Agreements / arrangements |
Memorandum of Understanding between the Federal Department of Home Affairs Acting on behalf of the Federal Council of the Swiss Confederation and the Therapeutic Goods Administration Department of Health of Australia regard Therapeutic Good (July 2015) |
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Scope |
Covers ‘medicinal products’ including:
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Exclusions |
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Applicable territory |
Inspections within Switzerland |
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
Cooperative agreements
A cooperative agreement is a written understanding that outlines the cooperative activities between the parties, including sharing information on manufacturers for medicinal product.
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.
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Regulatory authority |
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Agreements / arrangements |
Cooperative arrangement between US FDA and TGA regarding the Exchange of Information on current Good Manufacturing Practice Inspections of Human Pharmaceutical Facilities (October 2000) |
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Scope |
Covers ‘Human medicinal products’ including:
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Exclusions |
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Applicable territory |
Inspections within US |
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.
Other arrangements
We may use other arrangements for the purpose of GMP Clearance.
Pharmaceutical Inspection Cooperation Scheme (PIC/S)
Many regulatory authorities, including the TGA, are members of the PIC/S, which is a non-binding, informal, cooperative arrangement between the authorities that regulate GMP for medicinal products.
This joint membership of PIC/S enables us, in some circumstances, to allow evidence by these regulators to be submitted using the CV GMP clearance pathway. Refer to the list of PIC/S participating authorities.
We will not accept evidence from a PIC/S participating authority when:
- the inspection was performed outside the borders of that country
OR
- the inspection was performed prior to that authority's accession to PIC/S
If your evidence falls into either of these categories, you will not be issued a GMP Clearance and you will forfeit any fees you have paid.
Version history
| Version | Description of change | Author | Effective date |
|---|---|---|---|
| V1.0 | Original publication | Manufacturing Quality Branch | September 2017 |
| V1.1 | Included additional information on agreements and arrangements | Manufacturing Quality Branch | March 2023 |