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International agreements and arrangements for GMP clearance

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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. 

Regulatory authorityAustriaAustrian Agency for Health and Food Safety (AGES) 
BelgiumFederal Agency for Medicines and Health Products (FAMHP) 
BulgariaBulgarian Drug Agency
 		 
CroatiaAgency for Medicinal Products and Medical Devices of Croatia (HALMED) 
CyprusMinistry of Health - Pharmaceutical Services 
Czech RepublicState Institute for Drug Control (SUKL) 
DenmarkDanish Medicines Agency 
EstoniaState of Agency of Medicines (SAM) 
FinlandFinnish Medicines Agency (FIMEA) 
FranceNational Agency for the Safety of Medicine and Health Products (ANSM) 
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.

 
GreeceNational Organization for Medicines 
HungaryNational Institute of Pharmacy and Nutrition (OGYEI) 
IcelandIcelandic Medicines Agency 
IrelandHealth Products Regulatory Authority 
ItalyItalian Medicines Agency (AIFA) 
LatviaState Agency of Medicines (ZVA) 
LiechtensteinOffice of Health / Department of Pharmaceuticals 
LithuaniaState Medicines Control Agency (SMCA) 
LuxembourgMinistry of Health 
MaltaMedicines Authority 
NetherlandsHealth Care Inspectorate (IGZ) 
NorwayNorwegian Medicines Agency 
PortugalNational Authority of Medicines and Health Products (Infarmed) 
PolandChief Pharmaceutical Inspectorate 
RomaniaNational Agency for Medicines and Medical Devices of Romania (NAMMDR) 
Slovak RepublicState Institute for Drug Control (SIDC) 
SloveniaAgency of Medicinal Products and Medical Devices (JAZMP) 

Spain

 

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.

 
SwedenMedical Products Agency
Agreements / arrangements 
Scope

Covers ‘Human medicinal products’ including:

  • Prescription medicines
  • Over the counter medicines
  • Human biologicals, including vaccines, immunologicals and biotherapeutics
  • Radiopharmaceuticals
  • Medicinal gases
  • Homeopathic medicines, if classified as human medicinal product
  • Vitamins, minerals and herbal medicines, if classified as human medicinal products
  • Intermediate products and bulk pharmaceuticals
  • Active pharmaceutical ingredients, only for human medicinal products
Exclusions
Applicable territoryInspections within the countries listed above.

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.

Regulatory authority

Medicines & Healthcare products Regulatory Agency (MHRA)

Agreements / arrangements

MRA between Australia and the UK (January 2021) 

Scope

Covers ‘Human medicinal products’ including:

  • Prescription medicines
  • Over the counter medicines
  • Human biologicals, including vaccines, immunologicals and biotherapeutics
  • Radiopharmaceuticals
  • Medicinal gases
  • Homeopathic medicines, if classified as human medicinal product
  • Vitamins, minerals and herbal medicines, if classified as human medicinal products
  • Intermediate products and bulk pharmaceuticals
  • Active pharmaceutical ingredients, only for human medicinal products

Exclusions

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.

Regulatory authority

Health Canada

Agreements / arrangements

MRA between Australia and Canada (January 2006)

Scope

Covers ‘medicinal products’ including:

  • Prescription medicines
  • Over the counter medicines
  • Human biologicals, including vaccines, immunologicals and biotherapeutics
  • Intermediate products and bulk pharmaceuticals
  • Active pharmaceutical ingredients, only for human medicinal products

Exclusions
  • Pre-approval inspections
  • Clinical trial / investigational medicinal products
  • Advanced therapy medicinal products
  • Biologicals, such as human cell or tissued based products
  • Human blood and blood components and Haematopoietic Progenitor Cells (HPCs)
  • Complementary medicines not regulated as human medicinal products
  • Sunscreens not regulated as therapeutic goods

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.

Regulatory authority

Health Sciences Authority (HSA)

Agreements / arrangements

MRA between Australia and Singapore (June 2001)

Scope

Covers ‘Human medicinal products’ including:

  • Prescription medicines
  • Over the counter medicines
  • Human biologicals, including vaccines, immunologicals and biotherapeutics
  • Intermediate products and bulk pharmaceuticals
  • Active pharmaceutical ingredients, only for human medicinal products

Exclusions

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.

Regulatory authority

Medsafe

Agreements / arrangements

 
  • Arrangement between Medsafe and the TGA on cooperation and information sharing (April 2015)
  • Arrangement for the Mutual Recognition of GMP Audits of Manufacturers of Medicinal Products for Compliance with Good Manufacturing Practice (October 1996)

Scope

Covers ‘medicinal products’ including:

  • Prescription medicines
  • Over the counter medicines
  • Human biologicals, including vaccines, immunologicals and biotherapeutics
  • Intermediate products and bulk pharmaceuticals
  • Active pharmaceutical ingredients, only for human medicinal products
  • Complementary medicines including sunscreens

Exclusions

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.

Regulatory authority

Swiss Agency for Therapeutic Goods (Swissmedic)

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)

Scope

Covers ‘medicinal products’ including:

  • Prescription medicines
  • Over the counter medicines
  • Human biologicals, including vaccines, immunologicals and biotherapeutics
  • Intermediate products and bulk pharmaceuticals
  • Active pharmaceutical ingredients, only for human medicinal products

Exclusions

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.

Regulatory authorityUS FDA
Agreements / arrangementsCooperative arrangement between US FDA and TGA regarding the Exchange of Information on current Good Manufacturing Practice Inspections of Human Pharmaceutical Facilities (October 2000)
Scope

Covers ‘Human medicinal products’ including:

  • Prescription medicines
  • Over the counter medicines
  • Human biologicals, including vaccines, immunologicals and biotherapeutics
  • Radiopharmaceuticals
  • Medicinal gases
  • Intermediate products and bulk pharmaceuticals
  • Active pharmaceutical ingredients, only for human medicinal products
  • Sunscreens
Exclusions
  • Clinical trial / investigational medicinal products
  • Advanced therapy medicinal products
  • Biologicals, such as human cell or tissued based products
  • Human blood and blood components and Haematopoietic Progenitor Cells (HPCs)
  • Dietary supplements
Applicable territoryInspections within and outside 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 - external site.

We will not accept evidence from a PIC/S participating authority - external site when:

  • the inspection was performed outside the borders of that country

OR

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

VersionDescription of changeAuthorEffective date
V1.0Original publicationManufacturing Quality BranchSeptember 2017
V1.1Included additional information on agreements and arrangementsManufacturing Quality BranchMarch 2023
V 1.2Updated regulatory authorities recognised under MRA and clarification on US FDA agreements
 		Manufacturing Quality BranchDecember 2023

Related links

Access Consortium Good Manufacturing Practice (GMP) Statement
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