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The 7th Joint Conference of Taiwan and Japan on Medical Products Regulation in Taipei on October 1st 2019

【Update Date:2019-10-01unit:藥品組

The 7th Joint Conference of Taiwan and Japan on Medical Products Regulation is taking place on October 1st at Chang Yung-Fa International Convention Center in Taipei. The representatives from Taiwan Food and Drug Administration (TFDA) and Japan’s Ministry of Health, Labour, and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) share the latest information regarding the pharmaceutical regulations, as well as other important topics such as Precision medicine, ICH E17, E-labeling, OTC promotion polices, regulations on in-vitro diagnostic devices and priority review mechanism for medical device.

The deliverables of this conference include reaching and enhancing the mutual understandings of the regulatory information and the collaborations between regulatory authority and industries, helping the industries from both countries to have the advantage of entering international markets, and securing the public health in both countries.

Since the “Framework of the Cooperation on the Medical Products Regulation” was signed by Taiwan-Japan Relations Association and Japan-Taiwan Exchange Association in November 2013, TFDA works with MHLW and PMDA to establish working groups and host Annual Joint Conference in alternative turns for seven years.

Under this cooperation framework, the pharmaceutical and medical device working groups between TFDA and MHLW/PMDA continue to conduct cooperation activities, personnel exchange and short-term training programs. Working groups also jointly discuss about management, regulations and technical issues for medical products. The topics include new drug review regulation, implementation of the relevant guidance of the International Conference on Harmonisation (ICH) and constructing a novel co-review mechanism, etc. After the “Memorandum of Cooperation between the Japan-Taiwan Exchange Association and the Taiwan-Japan Relations Association on the field of Medical Device Quality Management System Requirement” was signed on November 30th 2018, both sides will cooperate to share and exchange the medical device Quality Management System (QMS) audit reports and the QMS compliance certifications. These collaborations and activities are expected to reduce the marketing barriers for both Taiwanese and Japanese manufacturers and promote the development of the industries in both countries.