Pharmaceuticals and Medical Devices Agency (PMDA) has succeeded in shortening the review period for medical products to the world's top standard through its 1st and 2nd Mid-term Plan Periods (FY 2004 to 2013). PMDA has been highly evaluated internationally for this and other achievements, and now positioned to contribute more to the world. In order to respond to the domestic and global expectations, PMDA has developed and announced its strategic plan titled "PMDA International Strategic Plan 2015".
This Strategic Plan outlines the international activities that will be conducted in the period defined in the 3rdand 4th Mid-term Plans, ending in FY 2023, taking into consideration the changes in the regulatory environment, as well as the Regulatory Strategy Initiative set forth by the Ministry of Health, Labour and Welfare (MHLW) in June 2015.
As the development, manufacture, and distribution of pharmaceuticals, medical devices, and cellular and tissue-based products are becoming increasingly globalized, PMDA must collaborate with foreign regulatory authorities and other related parties. PMDA will make strenuous efforts in its international activities along with conducting efficient and effective product reviews, implementing safety measures, and providing relief services.
Below are the key international actions set forth in the "PMDA International Strategic Plan 2015".
Establish the "Regulatory Science Center" for conducting first-in-the-world product reviews, implementing safety measures, and undertaking other activities, as well as publishing the outcomes.
Launch the "Asian Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs" to share PMDA's accumulated knowledge and experience in product reviews, implementation of safety measures, and provision of relief services with Asian and overseas regulatory authorities.
Cooperate with overseas regulatory authorities for expansion of harmonization activities (e.g., ICH, IMDRF) and work- sharing (e.g., GMP/QMS inspections)