Siyi Gu

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Articles

China Introduces A New Regulatory Data Protection And Exclusivity Mechanism

2 weeks ago | mondaq.com | Andrew Chen |John Tan |Alex Wang |Siyi Gu

AP Arnold & Porter More Arnold & Porter is a firm of more than 1,000 lawyers, providing sophisticated litigation and transactional capabilities, renowned regulatory experience and market-leading multidisciplinary practices in the life sciences and financial services industries. Our global reach, experience and deep knowledge allow us to work across geographic, cultural, technological and ideological borders.
China Introduces a New Regulatory Data Protection and Exclusivity Mechanism

2 weeks ago | arnoldporter.com | Andrew Chen |John Tan |Alex Wang |Siyi Gu

On March 19, 2025, China’s National Medical Products Administration (NMPA) released the Draft Implementing Measures and Working Procedures for Drug Clinical Trial Data Protection (the Draft Measures) for public comment, due by May 18, 2025.1 The Draft Measures, together with China’s regulatory schemes for patent linkage and market exclusivity, are a significant development in China’s regulatory data exclusivity protection and demonstrate Chinese regulators’ commitment to aligning with...
China Life Sciences: 2024 Year In Review

Jan 29, 2025 | mondaq.com | Andrew Chen |John Tan |Alex Wang |Siyi Gu

The life sciences industry remained a primary focus for Chineseregulators in 2024. Key developments such as China's firstdraft law regulating the medical device industry, the MedicalDevice Administration Law(《中华人民共和国医疗器械管理法（草案征求意见稿）》),and the Compliance Guidelines for Healthcare Companies to PreventCommercial Bribery Risks(《医药企业防范商业贿赂风险合规指引》),marked milestones in the development of China's regulatoryframework for the industry.
China Life Sciences: 2024 Year in Review

Jan 24, 2025 | arnoldporter.com | Andrew Chen |John Tan |Alex Wang |Siyi Gu

The life sciences industry remained a primary focus for Chinese regulators in 2024. Key developments such as China’s first draft law regulating the medical device industry, the Medical Device Administration Law (《中华人民共和国医疗器械管理法（草案征求意见稿）》), and the Compliance Guidelines for Healthcare Companies to Prevent Commercial Bribery Risks (《医药企业防范商业贿赂风险合规指引》) marked milestones in the development of China’s regulatory framework for the industry.
China's New Draft Administrative Measures For Management Of Medical Representatives

Dec 10, 2024 | mondaq.com | John Tan |Siyi Gu

AP Arnold & Porter More Arnold & Porter is a firm of more than 1,000 lawyers, providing sophisticated litigation and transactional capabilities, renowned regulatory experience and market-leading multidisciplinary practices in the life sciences and financial services industries. Our global reach, experience and deep knowledge allow us to work across geographic, cultural, technological and ideological borders.
The New Draft Administrative Measures For Management Of Medical Representatives

Dec 5, 2024 | mondaq.com | John Tan |Siyi Gu

AP Arnold & Porter More Arnold & Porter is a firm of more than 1,000 lawyers, providing sophisticated litigation and transactional capabilities, renowned regulatory experience and market-leading multidisciplinary practices in the life sciences and financial services industries. Our global reach, experience and deep knowledge allow us to work across geographic, cultural, technological and ideological borders.
The New Draft Administrative Measures for Management of Medical Representatives

Dec 4, 2024 | arnoldporter.com | John Tan |Siyi Gu

On November 28, 2024, China’s National Medical Products Administration (NMPA, 国家药品监督管理局), China’s equivalent of the U.S. Food and Drug Administration, issued the Draft Administrative Measures for Management of Medical Representatives for public comment (the Draft Management Measures, 医药代表管理办法) in conjunction with six other government agencies. The Draft Management Measures were issued for public comment, with a deadline of December 13, 2024.
China

Dec 4, 2024 | arnoldporter.com | John Tan |Siyi Gu

On November 28, 2024, China’s National Medical Products Administration (NMPA, 国家药品监督管理局), China’s equivalent of the U.S. Food and Drug Administration, issued the Draft Administrative Measures for Management of Medical Representatives for public comment (the Draft Management Measures, 医药代表管理办法) in conjunction with six other government agencies. The Draft Management Measures were issued for public comment, with a deadline of December 13, 2024.
Landmark Whistleblower Program For China's Healthcare Sector

Nov 5, 2024 | mondaq.com | John Tan |Siyi Gu

On October 10, 2024, the National Medical Products Administration in China released the Draft Rule on Rewarding Internal Whistleblowers for Reporting on the Quality and Safety Issues of Drugs and Medical Devices (the Draft Rule) for public comment, due by November 9, 2024.
Landmark Whistleblower Program For China's Healthcare Sector: Proposed Maximum Reward Of 1 Million RMB

Nov 4, 2024 | mondaq.com | Andrew Chen |John Tan |Alex Wang |Siyi Gu

On October 10, 2024, the National Medical Products Administration (NMPA) released the Draft Rule on Rewarding Internal Whistleblowers for Reporting on the Quality and Safety Issues of Drugs and Medical Devices (the Draft Rule) for public comment, due by November 9, 2024.1 The Draft Rule marks a milestone in the development of China's regulatory system for pharmaceuticals and medical devices and reflects Chinese regulators' increasing use of best practices from other jurisdictions as well as...