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RECENT CHANGES TO DRUG APPROVALS IN CHINA: REGULATORY CONSULTATION, IND SUBMISSION AND ACCEPTANCE OF FOREIGN DATA IN NDA

SHARESHARESHARE
Historically, the review and approval of a Chinese investigational new drug (IND) have taken a year or even longer to complete, and new drug application (NDA) approval for a new drug lagged behind Western countries by four or five years. Recently, the National Medical Products Administration announced changes to encourage pre-IND consultation and shortened the clinical trial approval process to 60 working days, opening up new opportunities to expedite development. Changes were also made to encourage NDA submissions that are aligned with submissions in other regions.