China NMPA Expands Generic Drug Consistency Evaluation to Ophthalmic, Transdermal, and Spray Formulations
BEIJING, September 2, 2026 — The National Medical Products Administration (NMPA) has issued Announcement No. 86 of 2026, officially expanding the scope of quality and therapeutic consistency evaluation for generic chemical drugs to include dosage forms beyond oral solid preparations and injections, effective immediately.
Phased Expansion Schedule
The evaluation program will now cover ophthalmic drops, transdermal patches, and spray formulations. According to the announcement, consistency evaluation for ophthalmic drops begins immediately upon publication. For transdermal patches and spray formulations, the program will launch on July 1, 2027.
Technical Requirements
Marketing authorization holders must select reference listed drugs from the NMPA-published Reference Preparation Catalog and conduct evaluations accordingly. The supplementary application for consistency evaluation shares the same technical requirements as generic drug marketing applications. Applicants must follow relevant NMPA technical guidelines and Chinese Pharmacopoeia standards, while also referencing applicable international regulatory requirements. Documentation should be organized following the CTD format, with summary sections prepared per CDE Notice No. 2020-2.
Clinical Trials and Review Process
For products requiring clinical trials, applicants must obtain clinical trial approval from the NMPA Center for Drug Evaluation (CDE) before commencing studies. The CDE will conduct comprehensive technical reviews, verification, and testing, issuing supplementary approval certificates for products that pass all evaluations.
Regulatory Framework
Other matters not covered by this announcement shall follow the provisions of CFDA Announcement No. 100 of 2017 and NMPA Announcement No. 102 of 2018 regarding generic drug consistency evaluation.
This expansion represents a significant step in China's ongoing efforts to ensure generic drugs meet the same quality and efficacy standards as their brand-name counterparts, ultimately benefiting patient access to affordable, high-quality medications.
