The China National Medical Products Administration (“NMPA”) issued the newly revised Medical Device Good Manufacturing Practice (hereinafter referred to as the “2025 GMP”) on November 4, 2025. This is the first full revision of the Medical Device GMP since the second revision in 2014. The 2025 GMP revises the main part of the Device GMP
China’s Drug Regulator Releases Report on Clinical Trial Progress in China
In June 2025, China’s Center for Drug Evaluation (“CDE”), which is one of the specialized product centers affiliated with China’s chief drug regulator, the National Medical Products Administration (“NMPA”), released a report titled “Annual Report on the Progress of Clinical Trials for New Drug Registration in China (2024).” The report presents data on clinical trials
China Proposes to Expand 30-Day Review Pathway for Innovative Drug Trials
China’s National Medical Products Administration (“NMPA”) recently issued the Draft Announcement on Optimizing the Review and Approval of Clinical Trials for Innovative Drugs (the “Draft Announcement”) for public comment. The Draft Announcement proposes to accelerate clinical trial reviews by shortening the timeline for certain innovative drugs from 60 business days to 30 business days. The
China’s Draft Environmental Code: Access and Benefit-Sharing for Chinese Non-Human Biological Resources – What Life Sciences Companies Should Know
On April 29, 2025, China released a landmark draft of its first unified Environmental Code, now open for public consultation until June 13, 2025. The 2025 Draft Environmental Code (“Draft Code”) consolidates and elevates into a single legal instrument many of China’s environmental laws, but it also marks a significant development in the regulation of
China’s NHC Issues Updated Guidelines on Human Genetic Resources Management
In late March and early April 2025, China’s National Health Commission (“NHC”) released a notice addressing frequently asked questions (“FAQ”) related to human genetic resources (“HGR”) management, along with additional shorter Q&A documents (see here and here), which answer one main question each. These publications mark the first set of guidelines issued by the
China Releases 2027-2035 Reform Blueprint for Life Sciences Industry
As China’s regulatory plans for drugs and medical devices for 2025 take shape, a recently released document provides a helpful blueprint for further reform from 2027 to 2035. The “Opinions on Comprehensively Deepening the Regulatory Reform of Drugs and Medical Devices to Promote the High-Quality Development of the Pharmaceutical Industry” (hereinafter referred to as the
China’s New Draft Measures for Medical Representatives Tighten Regulatory Compliance
On November 27, 2024, China’s National Medical Products Administration (“NMPA”) issued the Draft Measures for Medical Representative Administration (“Draft Measures”) for public comment. While the Draft Measures retain certain provisions from the 2020 version (“2020 Measures”)—such as prohibitions against medical representatives handling accounts receivables and processing purchase and sales notes, collecting individual HCP prescription volumes,
China Finalizes Long-Awaited Drug Domestic Responsible Person (Domestic Agent) Rule
On November 14, 2024, China’s National Medical Products Administration (“NMPA”) issued the Interim Provisions on the Administration of the Designation of Domestic Responsible Person by Overseas Drug Marketing Authorization Holders (the “Interim Provisions”). The Interim Provisions, which were issued after four years of discussion, lay out the appointment procedures and the required qualifications and obligations
China Implementing Pilot Work Program for Expedited Clinical Trial Review and Approval
China’s National Medical Products Administration (“NMPA”) recently issued the Notice on the Issuance of the Pilot Work Program for Optimizing the Review and Approval of Innovative Drug Clinical Trials (“Pilot Work Program”). This initiative aims to enhance the efficiency of the drug clinical trial review and approval processes. Under the Pilot Work Program, innovative drug
China’s NMPA Proposes Medical Device Administration Law
On August 28, 2024, the National Medical Product Administration (“NMPA”) in China released the draft Medical Device Administration Law (“Draft MDAL”) for public comment. Comments are due on September 28, 2024.
Since 2001, the framework legislation for medical devices has been a regulation, the Medical Device Supervision and Administration Regulations (“MDSAR”), which was last amended