Event Information

Time：October 31, 2014 (Friday)

Place：Tokyo, Japan

The 2nd Conference of Taiwan and Japan Medical Products Regulation was held on October 31, 2014 in Tokyo, Japan. A close-door meeting between the PMDA and the TFDA/CDE was organized on the next day. This conference discussed regulations concerning medical products of drugs, medical devices and health insurance. A delegation of 35 people representing the industry, the government and the academic in Taiwan flew to Tokyo to attend the conference.

Taiwanese and Japanese representatives gave speeches on the following four drug-related topics:

1. MRCT and New Drug Review - Dr Yoshiaki Uyama of the PMDA presented the MRCT review experiences and challenges and expressed that the ICH (E17): General Principle on Planning/designing MRCTs is to be announced in 2016-2018. Dr Chen Chi-Hsun presented the clinical trial capacity and the standards and experiences of bridging study assessment in Taiwan. Dr Chen also analysed the opportunities and restrictions concerning the development of new drugs based on a multi-nation clinical trial model.

2. Regenerative Products – Dr Daisaku Sato of the PMDA mentioned that the Japanese authority has implemented the Regenerative Products Promotion Act and carried out the reform on the Pharmaceutical Affairs Act. The Japanese authority gave the regenerative medical products a clear definition to separate them from drugs and medical devices. All Regenerative medical products are conditionally approved in Japan, meaning that the approval will be withdrawn if the product fails to prove its effectiveness in 7 years from its approval. So far, 2 regenerative medical products have been approved. Dr Lin Yi-Chu of the TFDA briefed that, in Taiwan, cell therapy products are now managed as “new products” instead of “new medical technologies”. Dr Lin also mentioned the challenges faced by the authority when reviewing applications, including 1) risk assessment; 2) long-term tracking; 3) quality and safety; 4) justification of efficacy. In the future, Taiwan and Japan could cooperate in the exchange of information, the design of training programs and the share of resources.

3. Nano Technology and Products – Dr Naomi Nagai of the PMDA mentioned that safety issue is the key concern for the review of nano drugs. Currently, the applications are reviewed on a case-by-case basis. Dr Chang Lin-Chau of the CDE talked about the major considerations for the review of nano drugs. Considering that the properties of a nano drug change according to the modification of its surface, the CDE may subject nano drugs to regulations similar to those for bio-similars. Currently, applications are reviewed on a case-by-case basis in Taiwan.

4. OTC – Dr Takatoshi Nakamura of the PMDA and Mr Lien Heng-Jung of the TFDA presented the management of OTC drugs in Japan and Taiwan respectively.

The participants were highly involved in the discussions, hoping this platform can extend the cooperation between Taiwan and Japan.

The TRPMA and its member companies attended the 2nd Conference of Taiwan and Japan Medical Products Regulation held in Tokyo.