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
Japan MHLW Publishes Recommendations on the Design and Analysis of Master Protocol Trials
Post contributed by guest blogger Miguel Kitamura of Kitamura Law. Not affiliated with Covington & Burling LLP.
Earlier this summer, the Pharmaceutical Evaluation Division of the Pharmaceutical Safety Bureau within the Japan Ministry of Health, Labor and Welfare (“MHLW”) published “Points to Note” summarizing key considerations for sponsors when planning, conducting, analyzing, and evaluating master protocol
SAMR Releases Draft Food Labeling Measures
China’s State Administration for Market Regulation (SAMR) released the new draft Food Labeling Supervision and Administrative Measures (the “Draft Measures”) for comment on June 28, 2024. The last draft food labeling measures were publicly released in 2020, but were never finalized. The Draft Measures provide requirements on font, size, manufacture date, and net
China Issues Proposal on Chemical Drug Pricing to Encourage Pharmaceutical Innovation
Earlier this year, China’s National Healthcare Security Administration (“NHSA”) issued the Notice on the Establishment of an Initial Price Formation Mechanism for Newly Listed Chemical Drugs to Encourage High-Quality Innovation (the “Proposal”) for comment from industry associations, but not the general public. NHSA officials disclosed that the Proposal was introduced in response to innovators’ calls
New Local Guideline Offers Important Insight on Cosmetics Advertising in China
In March, the Shanghai Market Supervision Bureau and the Shanghai Medical Products Administrative Bureau jointly issued the “Shanghai Cosmetic Industry Advertising Compliance Guidelines” (“Guidelines”). The Guidelines are based on the national Advertisement Law (as amended 2021) and Cosmetic Labeling Administration Provisions issued by the National Medical Products Administration in 2021. The Guidelines offer practical guidance