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From Command-Control to Lifecycle Regulation: Balancing Innovation and Safety in China's Pharmaceutical Legislation.
Jing Zhang1, Shuchen Tang1, Pengqing Sun1
1School of Law, Tsinghua University, Beijing 100084, China.
Healthcare (Basel, Switzerland)
|March 28, 2025
Summary
China
Area of Science:
- Pharmaceutical regulatory affairs
- Drug safety and innovation policy
- Global health governance
Background:
- China's pharmaceutical regulation is shifting from a command-control model to lifecycle regulation.
- This transition aims to balance drug safety, innovation, and accessibility.
- The study examines the evolution, achievements, and challenges of these regulatory reforms.
Purpose of the Study:
- To systematically examine the evolution of China's pharmaceutical regulatory framework.
- To analyze the achievements and challenges of China's regulatory reforms.
- To offer insights for global pharmaceutical governance.
Main Methods:
- Mixed-methods approach: historical analysis, policy text mining, case studies.
- Reviewed laws and regulations since 1949, including COVID-19 vaccine approvals.
- Comparative analysis with U.S. FDA and EU EMA frameworks.
Main Results:
- China's regulatory evolution identified in four phases: Emergence, Foundational, Deepening Reform, and Lifecycle Regulation.
- The 2019 Drug Administration Law institutionalized risk management and lifecycle oversight.
- Milestones include the Vaccine Management Law (2019) and stricter penalties (2020).
Conclusions:
- China's lifecycle regulation shows potential to harmonize safety and innovation, with improved API export compliance and faster approvals for breakthrough therapies.
- Challenges include uneven enforcement, conditional approval tensions, and supply chain reliance.
- Findings offer lessons for developing countries in regulatory reform.
Keywords:
China’s Drug Administration Lawglobal governanceinnovation–safety balancelifecycle managementpharmaceutical regulationMore Related Videos
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