The Center for Drug Evaluation (CDE), a key regulatory body in China, is currently in the process of soliciting public feedback on the 83rd batch of chemical generic reference preparations. This consultation period will remain open until June 24, 2024. The list under review encompasses 49 new specifications that are being considered for the first time, along with 19 additional specifications that have been appended to the existing register.
In this batch, 14 specifications have not met the review criteria, facing setbacks due to the absence of an established reference preparation status and/or a deficiency in safety data, among other reasons. This development is crucial for stakeholders in the pharmaceutical industry, as it impacts the approval and standardization processes for generic chemical drugs in the Chinese market.- Flcube.com
