On the 1st July 2020 the new Drug Regulation Registration (DRR) will be implemented in China. There are a number of significant changes within this new regulation covering new marketing applications, clinical trials, variations and renewals.
The update is designed to encourage innovation and generic development and improve the review process including shortening review times. A large number of technical sub documents to support the DRR are yet to be developed.
A number of key points from this new regulation are summarised below;