Fifteen “Urgently Needed” Drugs that are Manufactured Overseas have been Recently Approved to Access to the China Market within Ten Months of the Registration Process.

By Hong Chen, MSQ Healthcare Investment Analyst

Up to now, The Chinese Center for Drug Evaluation (CDE) released two lists of “Urgently Needed Foreign Pharmaceuticals”, including 78 new drugs that targeted on rare diseases, are life-saving, as well as have significant advantages compared with existing treatment methods.

New Policy for “Urgently Needed” Drugs

Chinese NMPA’s new policy established a special evaluation channel and priority review to fast track review and approve new drugs that are urgently needed. This change will at least shorten the length of time for the approval process to be registered in the China market for 1-2 years. The pharmaceutical companies can directly submit the applications on the basis of proof that there is no ethnic difference.  

Of the 15 Approved New Drugs – Average Approval Duration of 9.9 Months

Key Takeaways:

· The high cost for drug development and the small market demand make finding effective treatment challenging and time-consuming.

· The most recently issued drug regulations by the Chinese government developed an accessible pathway for foreign-approved drugs to enter into the China market faster.

· Pharmaceutical companies should consider entering the market sooner than later, as with the favorable policy, the competition might get more intense.

Source: Insight数据库