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This article discusses the regulation of DTx products in China, the question of registration, and best practices for collecting and processing data through DTx products.

On October 23, 2017, the China Food and Drug Administration ("CFDA") released the revised Administrative Measures for Drug Registration ("Draft for Comment") for public comment.

The State Council of the Chinese Central Government unveiled a revised Regulation on the Supervision and Administration of Medical Devices.

On August 9, 2024, China's State Administration for Market Regulation (SAMR) released a draft of the Anti-Monopoly Guidelines for the Pharmaceutical Sector (hereinafter referred to as the "AMGP")...

The deadline to submit comments is 22 Sep 2021. This was just announced earlier today (3 Aug 2021)...

With the information from Chenghua Luo of Amgen , which is highly appreciated, I write to report on the first drug patent term extension (DPTE) granted in China. Please correct me if anyone is aware of another DPTE granted in China earlier.

S Sam Li and Honghui Hu of Wan Hui Da – Peksung IP Group explain three important Supreme Court cases on pharmaceutical patents.

The item analyzes antitrust issues in special inspections, to provide advice for compliance in the pharmaceutical sector.

The National Development and Reform Commission (NDRC) published the Notice on Reinforcing Supervision over Drug Prices.

国家知识产权局公布2025年度十件专利复审无效典型案例，涵盖生物医药、人工智能、视频编码等多个技术领域。这些案例深入阐释了专利审查标准A

近日，国家知识产权局遴选出十件关注度高、影响力大、具备指导价值的2025年度专利复审无效典型案例，以深入阐释专利审查标准，明晰专利保护规则...

In 2026, Chinese regulators have continued their focus on anti-corruption enforcement in the life sciences industry.

Thanks to the heads up from Aaron Wininger , on 19 March 2025, the China National Medical Products Administration (NMPA) announced the draft Implementation Measures for Drug Trial Data Protection (IM), and their procedures.

This article reviews highlights of the recent amendments and discusses the provisions of the Second Revised Amendment.

For example, a DNA fragment that is designed by use of virus gene, synthetized and isolated, and aims for detecting the cases of the disease, can be patented.

China has recently unveiled its own version of a patent linkage system that has been highly watched by stakeholders and industry observers.

Chinese regulators intensified anti-corruption enforcement in the life sciences sector during 2026, with particular emphasis on medical insurance fraud, investigator-initiated studies, and patient programs.