Mutual recognition agreements (MRA)

The European Union (EU) has signed mutual recognition agreements (MRAs) with third-country authorities concerning the conformity assessment of regulated products. Such agreements contain a sectoral annex on the mutual recognition of good manufacturing practice (GMP) inspections and batch certification of human and veterinary medicines.

This content applies to human and veterinary medicines.

MRAs allow EU authorities and their counterparts to:

• rely on each other's GMP inspection system;
• share information on inspections and quality defects;
• waive batch testing of products on import into their territories;

Each agreement has a different scope.

MRAs are trade agreements that aim to facilitate market access and encourage greater international harmonisation of compliance standards while protecting consumer safety.

These agreements benefit regulatory authorities by reducing duplication of inspections on each other territory, allowing for greater focus on sites that could have a higher risk and broadening the inspection coverage of the global supply chain.

They also facilitate trade in pharmaceuticals because they reduce costs for manufacturers by reducing the number of inspections taking place at facilities and waiving re-testing of their products upon importation.

Find an overview of specific MRAs on this page. 

For more information about EMA's work to ensure good manufacturing practice:

• Good manufacturing practice

EMA's role

The European Commission is responsible to negotiate MRAs with partner countries on behalf of the EU. The European Commission may consult EMA on regulatory and scientific questions as part of this process.

EMA is involved in operational activities once the MRAs are in place, including:

• facilitating cooperation on inspections, including joint inspections and exchange of information on inspections;
• facilitating exchange of information and being the relevant contact point between the EU GMP inspectorates and partner authorities;
• operating the EudraGMDP database and connecting partners countries to it;
• responding to queries on the implementation of the MRA;
• involving partners countries in relevant EMA working groups, such as the GMP / Good-distribution-practice Inspectors Working Group;
• coordinating MRA maintenance activities.

For more information, see:

• European Commission: Mutual Recognition Agreements

Australia

Status	In operation since: 1 January 1999 for human medicines; 1 June 2001 for veterinary medicines.
Products covered	human chemical pharmaceuticals medicinal gases human biologicals, including vaccines, immunologicals and biotherapeutics human radiopharmaceuticals stable medicinal products derived from human blood or human plasma homeopathic medicines, if classified as medicinal product vitamins, minerals and herbal medicines if classified as medicinal products products intended for use in clinical trials, investigational medicinal products (IMPs), except those used in phase I clinical trials intermediate products and bulk pharmaceuticals active pharmaceutical ingredients, only for human medicinal products veterinary chemical pharmaceuticals premixes for preparation of veterinary medicated feedstuff veterinary immunologicals, including vaccines, immunologicals and biotherapeutics
Products excluded	advanced therapy medicinal products
Territorial applicability	Products manufactured in the territories of the EU and Australia.
Exchange of information	Exchange of certificates of GMP compliance for manufacturers and batch certificates. A two-way alert system is in operation.
Agreement	EU adoption decision on the MRA with Australia Amendment to the MRA with Australia (inclusion of active pharmaceutical ingredients in the operational scope) Agreement on mutual recognition in relation to conformity assessment, certificates and markings between the European Community and Australia - Final Act
Related content	Partners and networks: Australia

Canada

Status	In operation since 1 February 2003. In 2017, the MRA was suspended and incorporated into the Comprehensive Economic and Trade Agreement (CETA) between the EU and Canada, which applies provisionally as of September 2017. The suspended MRA will be terminated when CETA fully enters into force, pending ratification by EU Member States.  The first Joint Sectoral Group on Pharmaceuticals under CETA met in November 2018 and agreed a number of Administrative Arrangements. For more information, see:  Communication and Information Resource Centre for Administrations, Businesses and Citizens (CIRCABC): Meetings of the Joint Sectoral Group (JSG) of the Protocol to the Comprehensive Economic and Trade Agreement between the EU and Canada on the mutual recognition of the compliance and enforcement programs regarding good manufacturing practices (GMP) for pharmaceutical products
Products covered	human pharmaceuticals including prescription and non-prescription medicinal products or drugs and medicinal gases human biologicals including immunologicals and biotherapeutics human radiopharmaceuticals veterinary pharmaceuticals, including prescription and non-prescription medicinal products or drugs, and pre-mixes for the preparation of veterinary medicated feeds intermediate products and bulk pharmaceuticals products intended for use in clinical trials or investigational medicinal products; manufactured by the manufacturers holding a manufacturing authorisation or establishment licence vitamins, minerals and herbal remedies, homeopathic medicinal products (known in Canada as natural health products) manufactured by manufacturers holding a manufacturing authorisation or establishment licence in the case of Canada
Products excluded	stable medicinal products derived from human blood or blood plasma advanced therapy medicinal products active pharmaceutical ingredients veterinary biologicals
Territorial applicability	Products manufactured in the territories of the EU and Canada. GMP inspections of manufacturing facilities in third countries by a regulatory authority of either party may be accepted. This provision is applicable from 15 April 2021.
Agreement	Protocol on the mutual recognition of the compliance and enforcement programme regarding good manufacturing practices for pharmaceutical products
Related content	Partners and networks: Canada Communication and Information Resource Centre for Administrations, Businesses and Citizens (CIRCABC): Regulatory cooperation forum

Israel

Status	The MRA with Israel is an agreement on conformity assessment and acceptance of industrial products (ACAA). This is a specific type of MRA based on the alignment of the legislative system and infrastructure of the country concerned with those of the EU. In operation since 19 January 2013 (after Israel had implemented the relevant EU legislation and aligned its GMP standards, inspection procedures and forms to those used in the EU)
Products covered	human chemical and biological pharmaceuticals human immunologicals radiopharmaceuticals vitamins, minerals and herbal medicines if classified as medicinal products intermediate products and bulk pharmaceuticals active pharmaceutical ingredients excipients veterinary chemical pharmaceuticals premixes and preparation of veterinary medicated feedstuff veterinary biologicals except immunologicals Israel and the EU recognise official batch releases carried out by each other's authorities.
Products excluded	medicinal gases homeopathic medicines products intended to be used in clinical trials, investigational medicinal products (IMP) medicinal products derived from human blood or human plasma veterinary immunologicals advanced therapy medicinal products
Territorial applicability	Products manufactured in the territories of the EU and Israel and manufacturers in third countries inspected by the regulatory authority of either party if the product also undergoes re-control in one of the parties.
Exchange of information	Exchange of certificates of GMP compliance for manufacturers and batch certificates. A two-way alert system is in operation.
Agreement	EU adoption decision OJ L1/1 of 4.1.2013 ACAA text OJ L1/1 of 4.1.2013
More information	Implementation of ACAA - Information sheet Agreement between Israel and the EU on conformity assessment and acceptance of industrial products: Questions and answers
Related content	Partners and networks: Israel

Japan

Status	In operation since 29 May 2004 with limited scope. Updated in July 2018 to to include sterile and biological products and active pharmaceutical ingredients. This scope extension is effective as of 17 July 2018.
Products covered	Human medicines only, including: chemical pharmaceuticals; homeopathic medicinal products if classified as medicinal products and subject to GMP requirements in Japan; vitamins, minerals and herbal medicines if classified as medicines in the both parties; biological pharmaceuticals, including immunologicals and vaccines, that are: produced by cell culture utilising natural or recombinant microorganisms or established cell lines; derived from non-transgenic plants and non-transgenic animals; active pharmaceutical ingredients of any medicine covered in the agreement; sterile medicines that belong to any of the above categories.
Products excluded	veterinary medicines stable medicines derived from human blood or blood plasma advanced therapy medicinal products medicinal gases products intended to be used in clinical trials, investigational medicinal products (IMP)
Territorial applicability	Products manufactured in the territories of the EU and Japan.
Exchange of information	Exchange of certificates of GMP compliance for manufacturers through the EudraGMDP database and batch certificates. A two-way alert system is in operation. For more information, see: Japanese Pharmaceuticals and Medical Devices Agency (PMDA): GMP PMDA: Application procedure for GMP Certification between the European Union and Japan (in Japanese) Utilisation of EudraGMDP database in regulatory procedures in the context of the mutual recognition agreement between Japan and the European Union - impact on good-manufacturing-practice certificates Reference Number: EMA/568361/2013
Agreement	Agreement on mutual recognition between the European Union and Japan Agreement on mutual recognition in order to amend Part B of the Sectoral Annex on GMP Joint Committee Decision No 2/JP/2018 of 17 July 2018
Related content	Partners and networks: Japan PMDA Pharmaceuticals and Medical Devices Agency (in Japanese)

New Zealand

Status	In operation since: 1 January 1999 for human medicines; 1 June 2001 for veterinary medicines.
Products covered	human chemical pharmaceuticals medicinal gases human biologicals, including vaccines, immunologicals and biotherapeutics human radiopharmaceuticals stable medicinal products derived from human blood or human plasma homeopathic medicines, if classified as medicinal product vitamins, minerals and herbal medicines if classified as medicinal products products intended for use in clinical trials, investigational medicinal products (IMPs) intermediate products and bulk pharmaceuticals veterinary chemical pharmaceuticals premixes for preparation of veterinary medicated feedstuff veterinary immunologicals, including vaccines, immunologicals and biotherapeutics
Products excluded	advanced therapy medicinal products active pharmaceutical ingredients
Territorial applicability	Products manufactured in the territories of the EU and New Zealand, except Tokelau.
Exchange of information	Exchange of certificates of GMP compliance for manufacturers and batch certificates. A two-way alert system is in operation.
Agreement	Agreement on mutual recognition in relation to conformity assessment between the European Community and New Zealand
Related content	Partners and networks: New Zealand

Switzerland

Status	In operation since 1 June 2002.
Products covered	human chemical pharmaceuticals medicinal gases human biologicals, including vaccines, immunologicals and biotherapeutics human radiopharmaceuticals stable medicinal products derived from human blood or human plasma advanced therapy medicinal products homeopathic medicines, if classified as medicinal product vitamins, minerals and herbal medicines if classified as medicinal products products intended for use in clinical trials (investigational medicinal products - IMPs) active pharmaceutical ingredients intermediate products and bulk pharmaceuticals veterinary chemical pharmaceuticals premixes for preparation of veterinary medicated feedstuff veterinary immunologicals, including vaccines, immunologicals and biotherapeutics Switzerland and the EU recognise official batch releases carried out by each other's authorities.
Territorial applicability	Products manufactured in the territories of the EU and Switzerland and manufacturers in third countries inspected by the regulatory authority of either party if the product also undergoes re-control in one of the parties.
Exchange of information	Exchange of information on manufacturing/import authorisations and GMP compliance and non-compliance including through the EudraGMDP database. A two-way alert system is in operation. For more information, see: EU and Switzerland to improve information-sharing on good manufacturing practice through use of the EudraGMDP database Swissmedic: New application procedure for GMP certificates
Agreement	Agreement between the European Community and the Swiss Confederation on mutual recognition in relation to conformity assessment
More information	Explanatory notes to Chapter 15 (Medicinal products GMP inspection and batch certification) of Annex 1 of EU - Swiss MRA Mutual recognition agreements EC - Switzerland: Questions and answers covering interpretation of Chapter 15, explanatory notes, Annex 16 and notice to applicants Reference Number: EMEA/MRA/CH/84/02/Final
Related content	Partners and networks: Switzerland

United States

Status	Entered into force on 1 November 2017 for human medicines and 30 May 2023 for veterinary products. Fully operational for most human medicines as of 11 July 2019 and for veterinary products as of 29 May 2026, following a transition phase.
Transition phase	During a transition phase, the authorities assess each other's pharmaceutical legislation, guidance documents and regulatory systems as part of the agreement. Transitory provisions apply for vaccines for human use and plasma-derived medicines. Human medicines The transition phase for most human medicines covered by the agreement ended on 11 July 2019. As of 11 July 2019, qualified persons in the EU Member States do not need to batch test human medicines covered by the MRA, provided that they have verified that these controls have been carried out in the United States for products manufactured in and imported from the United States. Veterinary products The transition phase for veterinary products covered by the agreement ended on 29 May 2026. As of 29 May 2026, qualified persons in the EU Member States do not need to batch test veterinary products covered by the MRA. This is valid if that they have verified that these controls have been carried out in the United States for products manufactured in and imported from the United States.
Products covered	marketed finished pharmaceuticals for human use in various pharmaceutical dosage forms such as tablets, capsules, ointments, and injectables, including: medical gases; radiopharmaceuticals or radioactive biological products; herbal (botanical) products if classified as medicinal products; homeopathic products. marketed biological products: therapeutic biotechnology-derived biological products; allergenic products. intermediates active pharmaceutical ingredients or bulk drug substance veterinary products: veterinary pharmaceuticals, including prescription and non-prescription drugs, with the exclusion of veterinary immunologicals; pre-mixes for the preparation of veterinary medicated feeds (EU), Type A medicated articles for the preparation of veterinary medicated feeds (US).
Products excluded	human blood and plasma human tissues and organs veterinary immunologicals advanced therapy medicinal products
Products currently not included	vaccines for human use and plasma-derived medicines: postponed due to the COVID-19 pandemic. A new date for a decision on a possible expansion of the scope needs to be agreed between the EU and the US. However, the parties have agreed to start technical cooperation with a view to a future decision on possible expansion of the scope. products intended for use in clinical trials (investigational medicinal products): discussion at a later stage.
Agreement	Agreement on mutual recognition between the European Union and the United States of America, amending the Sectoral Annex for GMPs
Territorial applicability	Products manufactured in the territories of the EU and US. EU National Competent Authorities may accept official GMPs documents issued by US-FDA for manufacturing facilities located in third countries following a case-by-case assessment.
Exchange of information	Exchange of official GMPs documents. A two-way alert system is in operation.
More information	EMA, the European Commission and the FDA signed a confidentiality arrangement in August 2017 in the area of GMP inspections, allowing for the exchange of full inspection reports, including confidential information. For more information, see Partners & networks: United States. Questions and answers on the impact of Mutual Recognition Agreement (MRA) between the European Union and the United States as of 9 June 2026 Reference Number: EMA/INS/GMP/369445/2024 Q&A on impact of EU-USA Mutual Recognition Agreement on marketing authorisation applications and relevant variations - Revised 1st October 2025 Reference Number: EMA/237558/2023 Summary: Q&A on impact of EU-USA Mutual Recognition Agreement on marketing authorisation applications and relevant variations

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11 June 2026

'United States' section updated