The National Medical Products Administration (NMPA) of China has given the green light to Beijing and Shanghai to initiate pilot programs aimed at streamlining the review and approval process for innovative drug clinical studies. Announced via an official notice, the NMPA has decided to implement a pilot review and approval process for innovative drug clinical studies, which is targeted to be completed within a timeframe of 30 working days.
The pilot program’s scope is designed to encompass clinical trial applications for Category 1 innovative drugs, with the exclusion of cell and gene therapies and vaccines. Eligibility for participation in the pilot program is extended to applicants who have secured at least three novel drug clinical approvals internationally, demonstrating substantial experience in the execution of clinical studies and pharmacovigilance management. Applicants must also be capable of conducting comprehensive risk assessments for clinical trial projects and devising effective risk management plans prior to the submission of their clinical trial applications, regardless of their geographical location.- Flcube.com
