Summary
- China's National Medical Products Administration has unveiled new Implementation Measures for Drug Trial Data Protection, effective May 15, 2026.
- The Measures ensure equal protection for both domestic and foreign drugs, covering all test data used in marketing authorization applications.
- Applicants must submit a data protection application alongside their drug registration application to secure protection for up to six years.
- Failure to meet the submission deadline will result in a waiver of data protection rights, significantly impacting future drug approvals.
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