In 2017, the Chinese National Medical Products Administration (NMPA) was welcomed as a new regulatory member of the ICH. Only a year later, in June 2018, China’s health regulatory authority (National Medical Products Administration, NMPA) was elected to the ICH Management Committee, enabling the country to continue participating in international drug development and registration.

Chinese regulators are seeing more clinical studies of new drugs initiated by domestic startups, but they are concerned about slow clinical progress and inadequate care for young and old patients, a recent report revealed.

As an innovative shift in clinical trial monitoring model, Risk-based Quality Management (RBQM) strategy could improve the overall performance on cost saving and efficiencies of clinical trial, and provide a simple approach to reduce or limit potential risk.