Strategic Drug Development in China and Surrounding Countries

Abstract

Since 2007, international multicenter clinical trial (IMCT) pathway has been one of the major approaches for international pharmaceutical companies to register their investigational drugs in China. Companies favor IMCT since it allows sharing of global drug development resources, synchronizes global drug research and development processes, reduces cost by avoiding unnecessary repetition of clinical trials, and shortens the time gaps in drug marketing among countries or regions. Those advantages have been well accepted by the China Food and Drug Administration (CFDA). The CFDA encourages sponsors to carry out IMCT in China, especially in areas suffering from severe diseases or those with unmet clinical needs. At the same time, however, due to the fast speed of registration that may occur and, thus, insufficient data, that may exist, there is a concern for patient safety. Therefore, for drug registration in China, IMCT data shall be in line with the requirements of the CFDA regulations. In this section, we’ll introduce the development strategies with a focus on IMCT, its subtypes, the corresponding advantages and disadvantages of each potential pathway, the application processes, the surrounding country involvement options, and regulatory requirements and expectations.