To implement the relevant requirements of the "Opinions of the General Office of the State Council on Comprehensively Deepening the Reform of Drug and Medical Device Supervision to Promote High-Quality Development of the Pharmaceutical Industry" (State Council Office [2024] No. 53), and to promote the quality improvement of chemical generic drugs, the Center for Drug Evaluation has organized the drafting of the "Major Deficiency Scenarios in Pharmaceutical Research of Chemical Generic Drugs" and the "Major Deficiency Scenarios in Bioequivalence Research of Chemical Generic Drugs" (see Attachments 1 and 2). Following review and approval by the National Medical Products Administration, they are hereby issued, along with the following notice regarding related requirements:
1. The major deficiencies in pharmaceutical research now include three new scenarios: selection of starting materials not in compliance with ICH Q11, changes during the review period that require re-production of samples and re-evaluation of stability, and the use of multiple sub-batches combined in production without reasonable justification. Major deficiencies in bioequivalence research now include three new scenarios: metabolite studies not supporting evaluation, occurrence of serious adverse events related to the study drug, and clinically significant differences in time to peak or delayed absorption. These six scenarios apply to products newly accepted from the date of this notice, while products accepted before the issuance of this notice will be evaluated according to the original review criteria. The remaining major deficiency scenarios have all been long-established review requirements; for products newly accepted after the issuance of this notice, the review criteria will remain consistent with those for products currently under review.
2. For pharmaceutical research of three types of chemical generic drug marketing applications, considering that the original innovative drug is not marketed in China, the review agency will dynamically update information on the reference formulation's dosage process, quality research, stability studies, etc., and comprehensively determine whether it constitutes a major deficiency scenario.
3. Applicants should conduct self-inspections against this document before submitting a drug registration application and submit application materials that comply with current regulations and technical requirements to improve the quality and efficiency of their submissions.
Attachments:
Attachment 1: Major Deficiencies in Pharmaceutical Research of Generic Drugs.pdf
Appendix 2: Major Deficiency Situations in Bioequivalence Studies of Chemical Generic Drugs.pdf
National Medical Products Administration Center for Drug Evaluation, May 20, 2026
(Reprinted from: Official WeChat account of the Center for Drug Evaluation, National Medical Products Administration)