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PMDA offers consultations to give guidance and advice on clinical trials of drugs, medical devices, and cellular and tissue-based products as well as on data for regulatory submissions. In clinical trial consultations for new drugs, PMDA checks whether a proposed clinical trial complies with the requirements for regulatory submission, taking into consideration the ethical and scientific aspects and reliability of the clinical trial as well as the safety of trial subjects, and also gives advice to facilitate the improvement of the clinical trial. Starting in FY 2009, PMDA provides prior assessment consultations, in which its reviewers evaluate data on the quality, efficacy, and safety of a product in the pre-submission stage and
the consultation process constitutes part of the review of the product once the application is submitted.

In addition, PMDA has expanded and improved the consultation menu since FY 2007 so as to meet the various requirements for advice on product development and regulatory submission, in such categories as new medical devices and cellular and tissue-based products
that are developed using state-of-the-art technology.

Pharmaceutical Affairs Consultation on R&D Strategy

In order to achieve realization of innovative drugs, medical devices, and cellular and tissue-based products originating from Japan, PMDA launched the Pharmaceutical Affairs Consultation on R&D Strategy in July 2011, mainly for universities, research institutions, and venture companies that possess promising “seed-stage” research or technologies. In such consultations, advice will be provided on the tests needed in the early product development stage and the necessary clinical trials.

JCN 3010005007409

Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki,
Chiyoda-ku, Tokyo 100-0013 Japan

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