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.
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 EMA
- Renewal of confidentiality arrangement - Letter from MHLW and PMDA
Extension of confidentiality arrangement 2012
- Extension of confidentiality arrangement - Letter from European Commission and EMA
- Extension of confidentiality arrangement - Letter from MHLW and PMDA
Confidentiality arrangement 2007
- Confidentiality arrangement - Letter from European Commission and EMA
- Confidentiality arrangement - Letter from MHLW and PMDA
MRA and collaboration on GMP compliance
- 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.
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.
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:
The PMDA has a seconded a representative to the EMA's offices in London since late 2009.