On Feb. 22, 2022, China Center for Drug Evaluation (CDE) released its Work Procedures for Expediting the Review of Marketing Applications of Innovative Drugs (Trial) for public comments.
The Work Procedures applies to innovative drugs with Breakthrough Therapy Designation (BTD). The review for innovative BTD drugs' marketing authorization applications will be completed within 130 workdays1 after the submission. The time limit has been set as the same for Priority Review, which is much shorter than the 200-workday review for general applications.
An applicant can apply for BTD during phase I or phase II clinical trial if the proposed drug meets both conditions below2:
it is an innovative drug for a life-threatening disease or a disease that seriously impacts patients' life quality; and
the drug uses a new effective therapeutic method for the disease or has sufficient evidence that can prove substantial clinical improvement over the existing therapy.
RELATED: How to Apply for Breakthrough Therapy Designation
If the drug has been granted BTD, its applicant won't need to apply for priority review. The drug applicant can directly propose a meeting with CDE. The time limit is set at 30 workdays for pivotal-trial-related and pre-NDA (new drug application) meetings between the applicant and CDE to discuss substantial safety issues, technical issues, etc. To make the meeting efficient, CDE requires applicants to set the agenda according to the current research stage and submit supportive research data.
After the meetings, the applicant can submit NDA, which will automatically enter the priority review process. Furthermore, the pre-approval inspection of the drug's R&D and manufacturing sites will be prioritized.
The Work Procedures gives priority to breakthrough therapies in review and inspection for marketing authorization applications. That's because China encourages the development of such innovative therapies to tackle public health events. In the COVID-19 pandemic, China granted emergency approvals to innovative vaccines and drugs to contain the coronavirus. Drawing upon the experience of giving emergency approvals, CDE drafted the Work Procedures to offer regulatory support to innovative drugs.
