On September 2, the State Drug Administration issued a notice on carrying out consistent evaluation of the quality and efficacy of generic drugs in other dosage forms of chemicals. It was mentioned that the consistency evaluation will gradually be extended to dosage forms such as eye drops, patches, and sprays. The announcement began the consistency evaluation of eye drops on the date of publication, and the consistency evaluation of patches and sprays will commence on July 1, 2027. According to the announcement, drug marketing license holders should select reference formulations based on the “Catalogue of Reference Preparations for Chemical Generic Drugs” issued by the State Drug Administration and carry out research and development declarations with consistent evaluations. The supplementary application for consistency evaluation is consistent with the technical requirements of the chemical generic drug marketing application. Drug marketing license holders should carry out other dosage form consistency evaluation studies in accordance with the relevant technical guidelines issued by the State Drug Administration and the technical requirements of the “Chinese Pharmacopeia”. At the same time, they can also refer to the relevant technical requirements of foreign drug regulatory agencies. For varieties requiring clinical trials, the applicant shall submit a clinical trial application to the Drug Evaluation Center of the State Drug Administration, and clinical trials can only be carried out after obtaining permission for clinical trials. The Drug Evaluation Center of the State Drug Administration carries out technical reviews and initiates inspections in accordance with relevant regulations and technical guidelines, and summarizes the review, inspection and inspection conditions to form a comprehensive review opinion. Approved by the comprehensive review, certification documents for the issuance of supplementary drug applications.

On September 2, the State Drug Administration issued a notice on carrying out consistent evaluation of the quality and efficacy of generic drugs in other dosage forms of chemicals. It was mentioned that the consistency evaluation will gradually be extended to dosage forms such as eye drops, patches, and sprays. The announcement began the consistency evaluation of eye drops on the date of publication, and the consistency evaluation of patches and sprays will commence on July 1, 2027. According to the announcement, drug marketing license holders should select reference formulations based on the “Catalogue of Reference Preparations for Chemical Generic Drugs” issued by the State Drug Administration and carry out research and development declarations with consistent evaluations. The supplementary application for consistency evaluation is consistent with the technical requirements of the chemical generic drug marketing application. Drug marketing license holders should carry out other dosage form consistency evaluation studies in accordance with the relevant technical guidelines issued by the State Drug Administration and the technical requirements of the “Chinese Pharmacopeia”. At the same time, they can also refer to the relevant technical requirements of foreign drug regulatory agencies. For varieties requiring clinical trials, the applicant shall submit a clinical trial application to the Drug Evaluation Center of the State Drug Administration, and clinical trials can only be carried out after obtaining permission for clinical trials. The Drug Evaluation Center of the State Drug Administration carries out technical reviews and initiates inspections in accordance with relevant regulations and technical guidelines, and summarizes the review, inspection and inspection conditions to form a comprehensive review opinion. Approved by the comprehensive review, certification documents for the issuance of supplementary drug applications.