第10回DIAアジア新薬カンファレンス

CFDA has recently published anticipated regulatory reforms. The reforms represent several changes in China’s drug development and commercialization policies, which include but not limited to resolving the backlog of drug application, encouraging clinical drug development using MRCT, and pilot MAH program. Efficient development and launch of innovative new drugs is a top priority of China given growing public health problems that require rapid access to new medical treatments. China’s policy changes have the significant impact the global clinical development and manufacturing strategies of multinational pharmaceutical companies. In addition, these new policies reflect China’s willingness to be an active participant in global drug development and to encourage foreign companies to accelerate their drug development in China, which will provide a favorable opportunity to those who are involved in drug development. In this lecture, an experienced speaker will address recent regulatory changes in China and future prospects of the reforms clearly and concisely to help you to have better understanding on these drastically changing issues.