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The 5th Joint Conference of Taiwan and Japan on Medical Products Regulation in Taipei

【Update Date:2017-11-30unit:藥品組

The 5th Joint Conference of Taiwan and Japan on Medical Products Regulation is taking place on December 1st at Chang Yung-Fa International Convention Center in Taipei!

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, Taiwan Food and Drug Administration (TFDA) has been working closely with Japan’s Ministry of Health, Labour, and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) for five years.

Other than taking turns to hold the Joint Conference every year, direct contact in pharmaceutical and medical devices working groups between TFDA and MHLW/PMDA are established to jointly discuss about management, regulations and technical issues for medical products. The topics include new drug review regulation, bioequivalence regulation and review point comparisons etc.. Personnel exchange and short-term training programs were also conducted to learn from each other.

Currently, we are working on establishing cooperation scheme on new drug pilot program and signing the Memorandum of Cooperation for medical devices, in expectation with that these collaborations and activities could accelerate the marketing authorization and expand the market for industry from both sides.

In the other hand, in order to assist industry to be fully aware of and understand the medical products regulation in Taiwan and Japan, the Conference was held every year. This year, the 5th Conference will focus on the impact of MRCT after ICH E17 fully implement, review points of generic drugs and BE guideline in Japan, Taiwan generic industry, real-world data, evaluation of postmarket clinical benefits and risks of medium-high risk medical devices etc.. Speakers and participants are from government, industry and academia. By establishing the governmental-industrial-academic communication platform, related participants and stakeholders could share and learn from each other, and thus creating a win-win-win situation in the future.