Consistency Evaluation of Generic Drugs: June 2025 Update
Time:2025-07-09
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China‘s consistency evaluation of generic drugs continues to deepen, driven by policy incentives and technical optimizations, accelerating the industry‘s shift toward high-quality development. According to Moshang Data, 27 drug varieties (covering 39 application numbers) submitted consistency evaluation applications in June 2025. The majority were systemic anti-infectives, including:
Ampicillin Sodium for Injection
Faropenem Sodium Tablets
Cefotaxime Sodium for Injection
Amoxicillin-Clavulanate Dry Suspension.
Concurrently, 30 drug varieties passed consistency evaluations in June, such as:Vitamin B6 Injection、Diprophylline Injection、 Nicergoline Tablets、Epinephrine Hydrochloride Injection、Octreotide Acetate Injection
Trihexyphenidyl Hydrochloride Table、Cefotaxime Sodium for Injection.
Additionally, 245 drugs were deemed to have passed consistency evaluations, with cardiovascular medications ranking highest in proportion. Potassium Chloride Granules saw approvals from 7 manufacturers, while 22 varieties achieved first-time approvals.
Policy-Driven Acceleration
Policy incentives have expedited the review and approval process. A dedicated "green channel" enables immediate review of consistency evaluation applications upon submission, significantly boosting pharmaceutical companies‘ engagement in these initiatives.
Impurity Control: The Core of Quality Assurance
Impurity profiling is pivotal to consistency evaluation, directly determining whether generic drugs achieve substantial equivalence to originators in quality, safety, and efficacy. China‘s Technical Requirements for Consistency Evaluation of Generic Drugs mandates multi-batch comparative analysis of impurity profiles between generics and reference listed drugs (RLDs), ensuring impurity levels do not exceed those of RLDs.
SZEB supplies comprehensive impurity reference standards to support efficient compliance with consistency evaluations.
Product Coverage: Process-related impurities, degradation products, and isomer mixtures.
Certification: Full COA, H-NMR, MS, and HPLC data provided.
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