Event Information

Time：August 21, 2014 (Thursday) 01:30-05:30 p.m.

Place：TRPMA Conference Room
（1F, No. 465-1, Sec. 6, Zhongxiao E. Rd., Nangang Dist., Taipei City 11557, Taiwan）

The features of a huge population, various types of diseases and low research costs have made China one of the prime locations for international manufacturers to carry out multi-center clinical trials. This has contributed to the recent boom in the health industry in China. Therefore, how to successfully enter the market in China has become one of the major tasks for the research-based pharmaceutical manufacturers in Taiwan.

Hence, the TRPMA invited member companies who are interested in entering the Chinese market to attend the forum on “New Drug Registration Strategy in China” held on August 21, 2014 by the TRPMA.

Mr Chang Dan, the President and the CEO of the Fountain Medical Development Ltd in China, was invited to give a talk in the forum. However, due to other engagement, Mr Chang was not able to come. Instead, Dr Fu Wei-Ming, the Senior Operating Director of the Fountain Medical Development Ltd, was there in the Forum to deliver the talk. Dr Fu had 30-year working experiences in Novartis and was the Vice CEO of the Novartis Institutes for Biomedical Research. In the 2nd half of the Forum, a talk was given by Mr Hsia Chi-Kui, the Clinical Research Director of the Fountain Medical Development Ltd. Mr Hsia briefed the audience on the “progress of the multi-center clinical trials in China in the past decade” and the “research trial organization (CRO) and institutional review board in China”.

The Chinese authority announced the regulations governing multi-center clinical trials in China on December 1, 2002 and gradually brought the regulations into line with the regulations set by the US FDA. The CMC data is not required for the applications of IND. Also, NCEs are not subject to sample testing done by the National Institutes for Food and Drug Control except that biologics are subject to a test, sampled from one batch of the products. In China, a CRO management system has been gradually set up. Relevant announcements have been issued since 2011.

The talks delivered by Dr Fu and Mr Hsia gave the audience a good understanding of the clinical trials and drug registration systems in China as they are catching up with international standards. The biotech industry in Taiwan has to seize the opportunity and adopt the right approach in order to get a head start in the market in China.

Dr Fu Wei-Ming, the Senior Operating Director of the Fountain Medical Development Ltd, was introducing the “drug registration strategy in China”.