Korea and Japan Expand Pharmaceutical and Medical Device Cooperation... Sharing Regulatory Trends

Director-Level Bilateral Meeting on Medical Products Between MFDS and MHLW
Joint Pharmaceutical Symposium Held by Associations of Both Countries

The Ministry of Food and Drug Safety announced on July 17 that it will hold a bilateral director-level meeting in the pharmaceutical and medical device sectors with Japan's Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA), as well as a joint symposium between the pharmaceutical associations of both countries.

The meeting, which will be held in Tokyo, Japan until July 18, will cover topics including: cooperation in capacity-building education in the medical products field; the rapid introduction of innovative pharmaceuticals; information sharing and collaboration in areas such as Good Manufacturing Practice (GMP) for pharmaceuticals; and regulatory frameworks for digital medical products.

The Korea-Japan bilateral meeting has been held regularly since the signing of the Memorandum of Cooperation (MOC) in 2015. This year, in particular, marks the 10th anniversary of the MOC, and the focus will be on reviewing the achievements of past cooperation and expanding regulatory collaboration, including the introduction of innovative new drugs in both countries.

At the '6th Korea-Japan Public-Private Joint Pharmaceutical Symposium,' jointly organized by the government agencies of both countries, the Korea Pharmaceutical and Bio-Pharma Manufacturers Association, and the Japan Pharmaceutical Manufacturers Association, participants will share trends in Korea's pharmaceutical regulations and introduce strategies for clinical trial development, as well as the use of real-world data (RWD) and real-world evidence (RWE) in new drug development.

On the previous day, a meeting was held with domestic pharmaceutical companies that have entered or wish to enter the Japanese market, as well as with the Korea Pharmaceutical and Bio-Pharma Manufacturers Association, to share export experiences and actively collect feedback on challenges faced by companies.

The Ministry of Food and Drug Safety stated, "We expect that this bilateral meeting and symposium will further expand the cooperative network between the governments and private sectors of both countries, and serve as an opportunity for outstanding domestic medical products to actively enter the Japanese market."