“The 7th Taiwan-Japan Joint Conference on Medical Product Regulation” was closed on October 2 by the TFDA, MHLW and PMDA.  The three regulatory authorities jointly announced the position paper on the bilateral collaboration in new drug review.   The position paper laid down the principles and procedures for the Taiwan-Japan collaboration in new drug review with a view to building mutual trust in drug review, promoting industrial development, satisfying unmet medical needs and increasing drug accessibility in Taiwan and Japan.  This position paper is an important milestone in the history of the regulatory collaboration between Taiwan and Japan. The TFDA will continue reinforcing the communication with Japan under the Taiwan-Japan Drug Regulation Cooperation Framework Agreement in order to help the industry exploring the global market and to create a win-win situation for the regulatory agencies, industries and consumers.

The 7th Taiwan-Japan Joint Conference on Medical Product Regulation drew conclusions on issues concerning drugs and medical devices.  In the aspect of drugs, the results include the collaboration in new drug review, the promotion of generic drugs, the management of non-prescription drugs and the position paper on the collaboration in new drug review.  In the aspect of medical devices, it reached conclusions on the joint studies of internet safety guidelines, the development of in vitro diagnostic devices & the review guidance, the post-marketing monitoring mechanism, and a streamlined review    for imports from the other country.

This joint conference, acting as a communication platform under the Taiwan-Japan Drug Regulation Collaboration Framework Agreement, is an official taskforce created by the TFDA, MHLW and PMDA.  The taskforce meets once a year to discuss issues concerning drugs and medical devices and to encourage bilateral collaborations. 

The taskforce introduced the “Taiwan-Japan New Drug Review Collaboration Pilot Program” at the 5th meeting in 2017.  Since then, two joint new drug review projects have been carried out.  The two regulatory authorities exchanged review comments so as to increase the mutual understanding of the regulatory differences.  At this year’s meeting, the task force further established the position paper on the collaboration of new drug review in order to lay down the foundation of practical operations.

【2019-10-03/ TFDA】