China makes switch to faster approval system for imported drugs

NMPA and National Health Commission of China have established faster system to review and approve on urgently needed new drugs that have been approved in other countries

This regulation describes this specific faster pathway in terms of the applicable drug categories, the procedure of selecting drugs, the review and approval procedures, and related requirements. Estimated three months and six months for orphan drugs and other new drugs that have been on the US, EU, or Japan markets in the recent ten years to get the approval respectively. The regulation also states submission requirements, such as supportive documents, CTD filling requirements, ethnic sensitivity analysis reports, post-marketing study and the risk management activities, and the declaration of the consistency of dossier.

Issued by NMPA & NHC, REF[2018] No.79

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