The Center for Drug Evaluation (CDE) has released the 63rd batch of chemical generic reference preparations, adding 22 new specifications and updating information for 39 previously published specifications. This update is part of the CDE’s ongoing efforts to streamline the approval process for generic drugs and ensure the availability of high-quality, affordable medications.
Batch Details
In this batch, 41 specifications failed the review due to various reasons, including the uncertain status of their originators, lack of approvals in major markets such as the US, Europe, and Japan, and previous review failures. The CDE’s rigorous evaluation process aims to ensure that only high-quality generic drugs enter the market, thereby safeguarding patient safety and public health.
Future Outlook
The release of the 63rd batch underscores the CDE’s commitment to enhancing the generic drug market in China. By continuously updating and expanding the list of reference preparations, the CDE aims to support the development of the generic drug industry and improve access to essential medications for patients.-Fineline Info & Tech
