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Outline of International Activities

PMDA actively promotes international activities in line with the PMDA International Vision established in 2011.Specifically, emphases are placed on strengthening cooperation with the US, the EU, and Asian countries; participation in and contribution to international harmonization activities such as the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and International Medical Device Regulators Forum (IMDRF) and dissemination of information to the international community. In order to realize its International Vision, PMDA also established the Road map for the PMDA International Vision in April 2013, which clarifies more specific action plans and the goals to be achieved in the next few years, by recognizing the importance of restructuring its internal systems and organization, and by selecting the following five key areas for its international activities.

  1. Response to advanced science and technology
  2. Improvement of international operation basis (e.g.,fostering of human resources)
  3. Dissemination of English information on the review process of medical products,especially English translations of review reports
  4. Dissemination of safety information and international cooperation on safety measures
  5. Increasing leverage of Japanese Pharmacopoeia (JP)

In order to build closer partnerships with the EU and the US, PMDA has dispatched its staff members to foreign regulatory agencies including the European Medicines Agency and the U.S. Food and Drug Administration.
Moreover, PMDA’s ties with other regulators from the US, Europe, and Asia have been reinforced through the holding of PMDA Training Seminar and the exchange of trainees.

In addition, PMDA encourages its experts to take part in various international conferences regarding drugs and medical devices, and holds international symposia every year, thereby promoting interaction with many participants in those events. Also, PMDA makes every
effort to improve and expand its English website to provide the latest information to an international audience.

JCN 3010005007409

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