Japan

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The European Medicines Agency and the European Commission have a confidentiality arrangement with the Japanese Ministry of Health, Labour and Welfare (MHLW) and Japanese Pharmaceuticals and Medical Devices Agency (PMDA). The confidentiality arrangements allow exchange of information between the parties as part of their regulatory and scientific processes, both before and after a medicine has been approved.

The types of information covered include:

  • advance drafts of legislation and regulatory guidance documents;
  • scientific advice on medicine development;
  • assessments of applications for marketing authorisations;
  • information about the safety of marketed medicines.

The confidentiality arrangements cover human medicines subject to evaluation or authorised under the centralised authorisation procedure, as well as nationally authorised medicines subject to official European Union arbitration and referrals. They build on the previous mutual recognition agreement between the European Commission and Japan.

The arrangement was first signed in 2007 and was last extended in 2013 for a further five years.

The European Medicines Agency meets regularly with counterparts at the MHLW and the PMDA. Japan has also seconded a representative to the Agency’s offices in London since late 2009.

The Agency also works together with these authorities, together with the Japanese National Institute of Biomedical Innovation (NIBIO), on issues related to medicines for rare diseases.

Table of contents


Confidentiality arrangements

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Mutual recognition agreement

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Orphan medicines

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Document(s) Language Status First published Last updated Effective Date
European Union - Japan orphan medicines cooperation (English only)   2012-07-30    

Report on interactions

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Document(s) Language Status First published Last updated Effective Date
Report on interactions between the Japanese Ministry of Health, Labour and Welfare / Pharmaceuticals and Medical Devices Agency and the European Medicines Agency (English only)   2012-07-30