International agreements and arrangements for GMP clearance

19 September 2017

The TGA has entered into various international agreements and arrangements with other countries and regulatory authorities to support international regulatory collaboration. Some of these agreements and arrangements allow us to use inspections conducted by these regulatory authorities as part of the GMP clearance process in lieu of performing our own on-site inspection.

Whether an on-site inspection of a manufacturing facility is performed inside or outside the borders of a country is important, because this will determine the appropriate GMP clearance pathway.

You also need to decide whether your products are subject to regulatory frameworks and GMP standards that are different in Australia. This is particularly likely for:

  • biologicals, human blood and blood components and Haematopoietic Progenitor Cells (HPCs)
  • complementary and listed medicines, including sunscreens

The TGA may need to perform an on-site inspection of these manufacturers.

Regulatory Authorities for the MRA and CV GMP clearance pathways

The table below includes the countries and regulatory authorities with whom we currently have a Mutual Recognition Agreement (MRA) or an equivalent agreement/arrangement. The GMP clearance pathway for manufacturers inspected by these regulatory authorities is dependent on whether the inspection was performed within or outside their own boarders:

  • Use the MRA GMP clearance pathway for any of the countries listed in the table below when the regulatory authority has inspected a manufacturer within its own borders
  • Use the CV GMP clearance pathway for any of the countries listed in the table below (except New Zealand) when the regulatory authority has inspected a manufacturer outside its own borders
Countries with an MRA or equivalent arrangement with Australia
Country Regulatory authority

Austria

Austrian Agency for Health and Food Safety (AGES)

Belgium

Federal Agency for Medicines and Health Products (FAMHP)

Canada

Health Canada

Cyprus

Ministry of Health - Pharmaceutical Services

Czech Republic

State Institute for Drug Control (SUKL)

Denmark

Danish Medicines Agency

Finland

Finnish Medicines Agency (Fimea)

France

National Agency for the Safety of Medicine and Health Products (ANSM)

Germany

Federal Institute for Drugs and Medical Devices

Greece

National Organization for Medicines

Hungary

National Institute of Pharmacy and Nutrition (OGYEI)

Iceland

Icelandic Medicines Agency

Ireland

Health Products Regulatory Authority

Italy

Italian Medicines Agency (AIFA)

Latvia

State Agency of Medicines (SAM)

Liechtenstein

Office of Health / Department of Pharmaceuticals

Luxembourg

Ministry of Health

Malta

Medicines Authority

Netherlands

Health Care Inspectorate (IGZ)

New Zealand

New Zealand Medicines and Medical Device Safety Authority (Medsafe)

Norway

Norwegian Medicines Agency

Poland

Chief Pharmaceutical Inspectorate

Portugal

National Authority of Medicines and Health Products (Infarmed)

Singapore

Health Sciences Authority (HSA)

Slovak Republic

State Institute for Drug Control (SIDC)

Spain

Spanish Agency for Medicines and Health Products (AEMPS)

Sweden

Medical Products Agency

Switzerland

Swiss Agency for Therapeutic Goods (Swissmedic)

UK

Medicines and Healthcare products Regulatory Agency (MHRA)

Other regulatory authorities for the CV GMP clearance pathway only

United States Food and Drug Administration (US FDA)

We have a cooperation agreement with the US FDA. We accept evidence from the US FDA for GMP clearance applications using the CV pathway, irrespective of the country the inspection is performed in, as long as the inspection was performed using a comparable GMP standard.

European Directorate for the Quality of Medicines (EDQM)

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.

For the CV pathway, we will only accept the GMP certificate issued by an EU regulatory authority that also has an MRA or equivalent with Australia, together with the corresponding EDQM inspection report.

PIC/S member nations and the CV GMP clearance pathway

Many regulatory authorities, including the TGA, are members of the Pharmaceutical Inspection Cooperation Scheme (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.

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