Exclusive: China, Taiwan initiate mutual acceptance of clinical trial data

Drugmakers in mainland China and Taiwan who wish to access the two markets in a faster manner now have a solution, reports The Pharma Letters local correspondent Wang Fangqing.

Starting from April 25, clinical trial data provided by four Chinese hospitals – Peking Union Medical College Hospital, Peking University First Hospital, Shanghai Zhongshan Hospital and Shanghai Ruijin Hospital – can be used to apply for a New Drug Application in Taiwan, while China will also accept NDA filings using clinical trial data provided by four hospitals in Taiwan – Taipei Veterans General Hospital, Tri-Service General Hospital, National Taiwan University Hospital and Linkou Chang Gung Memorial Hospital. Previously, repeated clinical trials were required in each region to gain local NDA approval.

The agreement, which was signed between China’s Food and Drug Administration and the Institute for Biotechnology and Medicine Industry (IBMI) in Taiwan, is one big step forward after the cross-strait cooperation agreement for medicine and public health affairs signed between the two regions in 2010.