Event Information

Time: August 22-23, 2016 (Monday - Tuesday)

Place: TRPMA Conference Room

Biopharmaceutical Forum

Mr. Chang Dan, President of Fountain Medical Development Ltd., introduced the current development and trends of the biotech industry in China. He illustrated the background of the reform of the medical product management system and the “National New Drug Development Program” in China. Products qualified for the program will be fast tracked. Mr. Chang encouraged Taiwanese manufacturers to apply for the program. Mr. Fong Yi, Senior Vice President of Fountain Medical, pointed out that international practices have been incorporated into the drug registration system in China. Also, the criteria for multi-center clinical trials have been relaxed and been brought into line with international practices. Ms. Chang Li-Wen, Senior Clinical Research Director of Taigen Biotech, shared the company’s experiences of cross-strait R&D projects and discussed Taiwanese manufacturers’ opportunities in the Chinese market. Mr. Cho Yung-Ching, Senior Advisor of RDPAC, briefed the audience on the opportunities and challenges of cross-strait product R&D projects. He urged Taiwanese manufacturers to pool resources together and to collaborate in order to increase their chance of success. Finally, Ms. Xiao Li-Jun, Senior RA Director of Fountain Medical, explained the changes of the RA regulations in China and gave the audience valuable suggestions.

Medical Device Forum

Mr. Chang Wei-Fa, RA Manager of Fountain Medical, explained the history of the reform of the medical device management system in China. The authority in China has established a “Green Path” to fast track the review of innovative medical devices. In China, medical devices are graded according to the risk level. Grade 1 medical devices which do not require clinical trials are subject to self-report. Grade 2 and 3 medical devices require clinical trials unless otherwise regulated. Trial reports issued by testing institutes have to be submitted for product registration. Mr. Chang talked in detail about product registration techniques, clinical requirements and the verification of overseas clinical trial results.