In China, New Guidelines for Drug Evaluations Designed to Smooth Approvals of Urgently Needed Treatments

To shorten the amount of time needed for clinical trials of crucially-needed drugs, regulators in China in November issued a draft of technical guidelines to grant conditional approval of critical new treatments. In short, early-phase clinical data can be used to get conditional approval for urgently needed remedies.  Following such conditional use, the clinical trials must be finished and other factors like post-market clinical studies must still be completed.

The new draft guidelines are the result of three years of efforts by China’s Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). They are designed to ensure critically ill patients get access to new drug treatments and to smooth the pathway for vaccines and other treatments urgently needed for public health.

The guidelines apply to drugs shown to significantly improve disease outcomes and to those that can be used for patients who cannot tolerate or are adversely affected by existing treatments.