The Center for Drug Evaluation (CDE) has released the 62nd batch of chemical generic reference preparations, marking a significant update to its regulatory framework. This latest batch includes 27 new specifications and updates information on 39 previously published specifications, reflecting ongoing efforts to enhance the transparency and efficiency of China’s drug approval process.
However, 21 specifications failed to pass the review due to uncertainties regarding their originators’ status. These products either lack approvals in key markets such as the United States, Europe, or Japan, or have faced previous review failures for other reasons. Additionally, five varieties are currently on hold and will require further materials before they can proceed with the review process.
This development underscores CDE’s commitment to maintaining high standards for drug quality and safety while addressing challenges in global regulatory alignment. The updates highlight the importance of robust data validation and international collaboration in advancing China’s pharmaceutical industry.-Fineline Info & Tech
