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China Clears Life-Saving Drugs for Accelerated Approval Process

In a bid to accelerate the market entry process for certain priority drugs, the required registration procedures have been substantially revised:

  • A prioritised evaluation and approval procedure has been implemented in the case of pharmaceutical products deemed necessary for the treatment/prevention of life-threatening and rare diseases for which no alternative remedy is available
  • Providing data is available to demonstrate that ethnic variations do not compromise their efficacy, clinical trial data relating to the overseas use of particular pharmaceutical products in the treatment of life-threatening diseases may be submitted in support of any application for mainland use
  • The Centre for Drug Evaluation now has the discretion to waive the need for any prior product safety/risk control inspection with regard to unregistered drugs

These new measures, as jointly advanced by the State Food and Drug Administration and the National Health Commission, came into effect on 17 May this year.

For further details (in Chinese), please visit the following link:

Announcement of the State Food and Drug Administration and National Health Commission on Matters Concerning the Optimisation of the Evaluation and Approval Procedures for Drug Registration (No. 23 [2018])

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