Japan

The European Commission and European Medicines Agency (EMA) have had confidentiality arrangements with the Japanese Ministry of Health, Labour and Welfare (MHLW) and Japanese Pharmaceuticals and Medical Devices Agency (PMDA) since 2007, to allow the exchange of information between the parties as part of their regulatory and scientific processes. The European Union (EU) and Japan also have a mutual recognition agreement (MRA) in place on good manufacturing practice (GMP) compliance.

Confidentiality arrangement

EMA, the European Commission and MHLW and PMDA signed a confidentiality arrangement in 2007, which was last renewed in 2013 for five years.

The confidential information that EMA and PMDA can share includes:

• all legislation and guidance documents;, including non-financial documents;
• post-authorisation pharmacovigilance data, particularly in relation to adverse drug reactions, as well as safety concerns arising from periodic safety update reports and post-authorisation obligations and commitments;
• applications for scientific advice, orphan designation, marketing authorisation or post-authorisation activities of significant public health interest;
• applications for agreement of paediatric investigation plans;
• good-clinical-practice (GCP) inspections for specific products and GCP inspection reports;
• information technology systems supporting regulatory processes.

Exchange of letters

Renewal of confidentiality arrangement 2013

Renewal of confidentiality arrangement: Letter from European Commission and European Medicines Agency to Ministry of Health, Labour and Welfare and Pharmaceuticals and Medical Devices Agency

Renewal of confidentiality arrangement: Letter from Ministry of Health, Labour and Welfare and Pharmaceuticals and Medical Devices Agency to European Commission and European Medicines Agency

Extension of confidentiality arrangement 2012

Extension of confidentiality arrangement: Letter from European Commission and European Medicines Agency to Ministry of Health, Labour and Welfare and Pharmaceuticals and Medical Devices Agency

Extension of confidentiality arrangement: Letter from Ministry of Health, Labour and Welfare and Pharmaceuticals and Medical Devices Agency to European Commission and European Medicines Agency

Confidentiality arrangement 2007

Letter from Japan to the European Union

Letter from the European Union to Japan

 

MRA and collaboration on GMP compliance

The EU and Japan signed a mutual recognition arrangement (MRA) on good manufacturing practice (GMP). This allows EU authorities and their Japanese counterparts to:

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

For more information on MRAs and the scope of the EU-Japan MRA, see:

• Mutual recognition agreements

EMA also participates in initiatives with partner authorities, including the PMDA, on GMP inspections which aim to better distribute inspections capacity, allowing more sites to be monitored and reducing unnecessary duplication. 

For more information, see:

• International collaboration on GMP inspections

Cluster activities

The agencies, together with other non-EU regulators, hold regular meetings by phone or videoconference in so-called 'clusters'.

The clusters are areas of cooperation focusing on special topics and therapeutic areas identified as requiring an intensified exchange of information and collaboration.

For more information, see:

• Cluster activities with regulatory partners

Other areas of cooperation

Fellowships

EMA, the MHLW and PMDA have agreed to establish a fellowship programme in 2017, which involves exchanging staff for a short period of time. These exchanges enable the agencies to exchange best practices, enhance mutual understanding and work together more closely.

For more information, see:

• Fellowships

Cooperation on orphan medicines

In 2012, EMA and PMDA signed a pilot terms of reference for the cooperation between the EU and Japan on orphan medicines:

• European Union - Japan orphan medicines cooperation

EMA also cooperates, together with the PMDA, with the Japanese National Institute of Biomedical Innovation on issues related to orphan medicines.

Representation

The PMDA has a seconded a representative to the EMA's offices since late 2009.