Technical Guidelines for CMC Study on Generic Chemical Ophthalmic Solution

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Technical Guidelines for CMC Study on Generic Chemical Ophthalmic Solution

Local Title:化学药品仿制药溶液型滴眼剂药学研究技术指导原则
Country/Region:Chinese Mainland
Competent Authority: Center for Drug Evaluation (CDE)
Type:Guideline
Status:In force
Release Date:2023-02-16
Implementation Date:2023-02-16

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Language	Source	Title	Access
ZH	Official	化学药品仿制药溶液型滴眼剂药学研究技术指导原则	Download

Summary

The guidelines apply to generic chemical ophthalmic solution.

Given the attributes of ophthalmic solution products, the guidelines put forward the technical requirements for the development of such drugs' generic versions.