New drug applications on rise in China

With clinical research and regulatory filings booming in China, regulatory authorities are receiving a record number of drug applications for new clinical trials and drug approvals. Last year, more than 5,500 applications for technical review were filed with China’s Center for Drug Evaluation (CDE), an increase of almost 50 percent over the year before. The rise reflected a rise in registration submittals of Chinese medicines, chemical drugs, and biological products. And new drug applications alone rose by more than 40 percent.

China’s pharmaceutical review agency approved 106 new drugs for marketing in the country last year, among them 67 imported foreign innovative products. The approvals by the National Medical Products Administration’s Center for Drug Evaluation (CDE) come on the heels of a series of reforms over the past four years which have speeded and streamlined that approval process for pharmaceuticals, especially those considered urgent or essential for care.