What Is the 60-Day Silent Approval Mechanism for Clinical Trials in...

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2026-06-30 13:21:03 -

What Is the 60-Day Silent Approval Mechanism for Clinical Trials in China

China has become a major destination for global clinical development, and one reason is its 60-day silent approval mechanism for clinical trials. Introduced as part of China’s drug Regulatory reforms and outlined under the National Medical Products Administration (NMPA) framework, this mechanism allows sponsors to begin clinical trials if regulators do not raise objections within 60...

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