What is a Clinical Trial Default Approval?

A clinical trial default approval is a drug review and approval system that allows applicants to conduct drug clinical trials according to their submitted plan if the drug review agency does not provide a denial or questioning opinion within a specified review period. The implementation of this system is a major reform of the drug review and approval system, aiming to accelerate the process of new drug clinical trials, improve review and approval efficiency, and encourage innovation in the pharmaceutical industry.

Specifically, the clinical trial default approval system means that after submitting a new drug clinical trial application (IND), if the review agency does not raise any objections or requests for additional information within the stipulated time, the applicant can proceed with the clinical trial. This system varies across different countries. For example, in the United States, the FDA has 30 days to decide whether to allow the drug to be tested on humans. If the FDA does not contact the drug applicant within 30 days after submitting the IND, the IND is deemed approved, and the applicant can begin clinical trials.

The implementation of the clinical trial default approval system is of great significance for shortening the waiting time for new drug clinical trials and accelerating the research, development, and marketing of new drugs. It also reflects the emphasis on the principle of administrative efficiency in the drug review and approval process. By setting clear time limits, it urges the review agency to improve the approval speed while safeguarding the applicant's legitimate interests, allowing them to legally conduct clinical trials even without receiving a notification from the review agency.

Moreover, the default approval system also includes mechanisms for monitoring and suspending clinical trials to ensure their safety and compliance. This system strikes a balance between drug safety and approval efficiency, promoting the rapid marketing of new drugs while also ensuring the safety of trial participants.