The State Drug Administration issued a notice deciding to carry out consistency evaluations with other dosage forms of chemical drugs. The announcement proposes to gradually expand the consistency evaluation to dosage forms such as eye drops, patches, and sprays. Drug marketing license holders shall select reference formulations according to 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 consistency evaluation of eye drops will commence on the date of publication of this announcement, and the consistency evaluation of patches and sprays will commence on July 1, 2027.

Zhitongcaijing · 3d ago
The State Drug Administration issued a notice deciding to carry out consistency evaluations with other dosage forms of chemical drugs. The announcement proposes to gradually expand the consistency evaluation to dosage forms such as eye drops, patches, and sprays. Drug marketing license holders shall select reference formulations according to 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 consistency evaluation of eye drops will commence on the date of publication of this announcement, and the consistency evaluation of patches and sprays will commence on July 1, 2027.