China & APAC Food, Drug, Device, and Cosmetics

Legal news and insights from Covington's China & APAC regulatory experts.

Contributors for the China & APAC Food, Drug, Device, and Cosmetics Blog blog:

John BalzanoJulia PostMuyun Hu, Annie Wang, Kaixin Fan, and Kexin Yang.

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,

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’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

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

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

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

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

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

China’s State Administration for Market Regulation (“SAMR”) recently issued proposed Measures on Supervision and Administration of Entrusted Manufacturing for Food (the “Proposed Measures”). The Proposed Measures expand the rights and obligations of companies that entrust food manufacturing to a licensed food producer in China. Consistent with other recent rules, such as the Administrative Measures for

China’s State Administration for Market Regulation (“SAMR”) is seeking public comment on its proposed amendment to the country’s Food Safety Law.  The amendment is intended to include ready-to-drink liquid infant formula in the current regulatory regime for powder infant formula, as part of the implementation of the “Four Strictest” principles for food safety (i.e., the most stringent