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The 6th Joint Conference of Taiwan and Japan on Medical Products Regulation in Japan 【Date:2018-10-11】 unit:藥品組

The 6th Joint Conference of Taiwan and Japan on Medical Products Regulation is taking place on the 11th October 2018 at Tokyo Japan. This year the representatives from TFDA, Centre for Drug Evaluation (CDE), National Health Insurance Administration (NHIA), medicinal products and medical devices industrial associations will visit Japan and share the latest information about the pharmaceutical regulations, the managements of the real world date and how is it applied to the pharmaceutical regulations, policies that promote OTC drugs and the adjustments of the NHI reimbursements with the representatives from Japan’s regulatory authorities and industries. Through this opportunity, we hope that the mutual understandings of the regulatory information from both countries can be reached, and the collaborations between regulatory authorise and industries from both countries can be enhanced. We look forward to increasing the regulatory review standards, helping the industries to have the advantage of entering international markets, as well as securing the public health.

The Joint Conference of Taiwan and Japan on Medical Products Regulation” is one of the communication platforms under the “Framework of the Cooperation on the Medical Products Regulation,” which was signed by “Taiwan-Japan Relations Association” and “Japan-Taiwan Exchange Association” on November 2013. Taiwan Food and Drug Admistration (TFDA) and Japan Ministry of Health, Labour and Welfare (MHLW) / Pharmaceuticals and Medical Devices Agency (PMDA) have formed several working groups, through which Taiwan and Japan have been communicating and exchanging information about pharmaceutical policies and regulations regularly. Taiwan and Japan have also co-organised annual conferences alternatively. This year is the sixth year of the collaborations.

Under the framework, the working groups included activities such as two-sided official visits and observations, as well as discussions and comparisons of some of the highly interested topics in new drug regulations and review standards. Taiwan and Japan also co-organised a workshop on the 8th May this year to share regulatory updates for bioequivalence studies. In addition, Taiwan and Japan is currently constructing a novel co-review mechanism and on the preparation of signing MOC for the Medical Devices as well. TFDA looks forward to shortening the review times for medicinal products and medical devices and helping Taiwan industries to prosper.