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In December, Chinese regulators have rejected over 100 applications for generic drugs, following a significant tightening of the approval process driven by new draft review standards. As of the 19th, the country had turned down 102 generic drug applications this month alone—more than double the total number rejected throughout the entire previous month. This figure does not account for applications voluntarily withdrawn by manufacturers.
The draft guidelines on generic drug review standards, released by the National Medical Products Administration’s Center for Drug Evaluation on December 3rd, specify that applications with major deficiencies will be outright rejected rather than subject to further discussions.
Industry stakeholders noted that since these new review standards were clarified earlier this month, a considerable number of applications have been impacted. Major issues highlighted in the draft include inadequate or insufficient bioequivalence data, errors in analytical testing, flaws in statistical methodologies, inadequate explanations for protocol deviations during trials, and errors or missing information in application dossiers.
The stricter review criteria aim to address problems related to low-level duplication in generic drug R&D and to limit excessive competition among manufacturers. Experts believe that for drugs with high market saturation and multiple existing similar treatments, the benefit of developing additional generics is limited. As Zhou Liyun, chair of a pharmaceutical data service company, pointed out, regulatory policies should steer research and development investments towards meaningful innovations to avoid unnecessary resource waste.
Among the drugs rejected this month are treatments for various conditions, many of which already have multiple approved options. For example, over 60 pharmaceutical companies had previously received approval to produce amlodipine besylate tablets, a common antihypertensive medication.
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