The Center for Drug Evaluation (CDE) has unveiled a new set of “Work Specifications to Accelerate Novel Drug Market Filing Reviews,” targeting the acceleration of innovative pediatric and rare disease drug development, as well as the overall advancement of innovative drug research and development.
Scope of Application: Innovative Pediatric and Rare Disease Drugs
The new guidelines apply to innovative drugs for children, rare diseases, and those within the breakthrough therapy designation (BTD) channel, excluding special review and approval categories. “Children-specific innovative drugs” encompass Class 1 innovative drugs tailored for pediatric use, including a range of pharmaceuticals such as chemicals, vaccines, therapeutic biologics, and traditional Chinese medicines (TCMs). Similarly, innovative drugs for rare diseases are Category A drugs addressing conditions with very low incidence rates, also spanning across chemical drugs, vaccines, therapeutic biologics, and TCMs.
Breakthrough Therapy Designation (BTD) Program Inclusion
For drugs included in the BTD program, applicants are to follow existing protocols for communication applications and marketing approval filings, with no additional applications required. It is a prerequisite that innovative drugs must have achieved BTD status to be considered under these specifications.
Applicable Conditions and R&D Stages
Applicants must meet the criteria for conducting confirmatory clinical trials after the completion of exploratory clinical trials and must apply before the New Drug Application (NDA) filing. Follow-up communications should be conducted in line with the provided guidelines. For innovative drugs under conditional approval consideration, this process can be initiated even before the completion of exploratory clinical trials.
Application for Listing and Time Limit Requirements
Applicants are required to submit an application for priority review and approval when applying for a drug listing license. The communication and exchange time limit is set at 30 days, and the review time limit mirrors that of priority review varieties, which is 130 days.-Fineline Info & Tech
