Issuance of the Procedures and Technical Requirements for Drug Registration Testing (2025 Revision)
ISSUING AUTHORITY:
National Institutes for Food and Drug Control
DATE OF ISSUANCE:
July 14, 2025
EFFECTIVE DATE:
August 1, 2025
The Procedures and Technical Requirements for Drug Registration Testing (2025 Revision) (the “Procedures”), issued by the National Institutes for Food and Drug Control (NIFDC) on July 14, 2025, has officially came into effect on August 1, 2025. Developed through five years of implementation experience and incorporating multiple parties’ advice, this version comprehensively refines the old version (i.e. 2020 Provisional Edition). The key points of this revision are as follows:
Firstly, the scope of drug pre-registration inspection has been expanded. Pre-Registration Inspection, a key mechanism allowing eligible registration inspection to commence prior to formal application submission, thereby accelerating drug review efficiency, is now extended from exclusively pre-market applications to include supplemental applications.
Secondly, sample requirements for registration inspection have been reduced. The Procedures stipulate that for routine drug registration inspection, the sample volume per batch is reduced from triple the testing amount to double the testing amount, and for orphan drug registration inspection, sample requirements are reduced from three batches at triple volume to one batch at double volume. Additionally, the Procedures relax validity period requirements: if the remaining shelf life is insufficient to cover twice the registration testing duration, applicants may negotiate with drug testing institutions to use such samples for testing upon mutual agreement, provided they meet testing needs.
Thirdly, testing timelines have been shortened. The Procedures introduce accelerated deadlines: testing for products under priority review is shortened by 10 working days; testing for clinically urgent orphan drugs already marketed overseas but not domestically is reduced by 20 working days.
Last but not least, the Procedures have introduced multiple process optimization initiatives, such as enhancing communication with applicants to minimize repeat testing during review, and refined requirements for packaging configurations and multi-strength formulation samples, among other refinements.
The Procedures represents a milestone achievement in deepening China’s pharmaceutical regulatory reform, marking a decisive shift from “passive supervision” to “a proactive service-oriented approach” in drug oversight.
