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2 months ago | 
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.
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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.
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Dec 10, 2024 | 
mondaq.com | John Tan |Siyi Gu
AP
Arnold & Porter
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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.
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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.
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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.
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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.
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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.
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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...
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Oct 29, 2024 | 
arnoldporter.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...
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Oct 16, 2024 | 
mondaq.com | John Tan |Siyi Gu
On October 11, 2024, the State Administration for Market
Regulation (SAMR,
国家市场监督管理总局)
issued the Draft Compliance Guidelines for Healthcare
Companies to Prevent Commercial Bribery Risks (the Draft
Guidelines,
医药企业防范商业贿赂风险合规指引). These Draft Guidelines were published for public comment, due by
Sunday, October 20, 2024. While China's public comment system
is still developing, the Draft Guidelines provide valuable insight
into regulators' views and expectations.
