Event Information

Time：October 12, 2015 (Monday)
Place：TRPMA Conference Room

TRPMA hosed a seminar on the management of cross-strait clinical trials. Representatives of the GCP Union in China were invited to attend the seminar and exchange their views with the audience in Taiwan.

The seminar was opened by Dr Chen Chien-Wei, Director of the Clinical Trial Center of the National Taiwan University. Ms. Cheng Jin-Lien, a supervisor of the GCP Union, gave the first talk about the current situations and prospects of the clinical trials in China. She briefed the audience on the current situation of the management of clinical trials on drugs in China and the concepts behind the CFDA’s management. In China, a fast track review procedure has been established based on the excellence of drug review mechanism in order to clear the backlog of applications.

Mr Huagn Guo-Long, the General Manager of Taigen Biotechnology Beijing Office, also gave a speech about Taiwanese new drug developers’ experiences and strategies of conducting cross-strait clinical trials. He talked about the experience in communicating with the CFDA and the CDE in China and the difficulties encountered while conducting clinical trials. He stressed that it is important to be familiar with the regulations and medical practices in China.

The third speaker was Dr Fu Wei-Min from Fountain Medical Development Ltd. in China. He compared the clinical trials in China and the US, as well as introduced the latest developments in China. Dr Fu briefed the audience on the government’s strategies to reform clinical trials as stated in the No. 44 Announcement issued by the State Council of China.

Representatives of the government and the industry exchanged their experiences and opinions afterwards.