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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 introduces staff fellowships programme with MHLW/PMDA (new)

The European Commission and EMA have cooperated with the Japanese MHLW and PMDA since signature of a confidentiality arrangement in 2007. As part of this, the EMA has benefitted from having an MHLW/PMDA liaison official located in the Agency’s offices since late 2009.

To build on experience of scientific exchanges over the years, EMA welcomes the introduction of a new EMA staff fellowships programme in 2017. The first three-week fellowship visit takes place in October 2017, focusing on procedural aspects of medicines assessment, from pre-marketing to post-marketing stages. 

In addition to improving mutual understanding of the agencies’ respective processes, it is hoped to deepen effective collaborations in strategic areas, promote regulatory science, and share successful experiences between the agencies.

Further EMA staff fellowship visits to the MHLW and PMDA are planned, linked to implementation of different projects. This initiative supports the EU Medicines Agencies Network Strategy to 2020, as well as the PMDA International Strategic Plan 2015.

Fore more information, see:

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:

Exchange of letters

Renewal of confidentiality arrangement 2013

Extension of confidentiality arrangement 2012

Confidentiality arrangement 2007

MRA and collaboration on GMP compliance

The EU and Japan signed a MRA on 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.

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:

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 in London since late 2009.

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