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
Co-authored by guest bloggers Alison Scott and Bianca Wu of Howse Williams. Not affiliated with Covington & Burling LLP.
In his 2023 Policy Address on October 25, 2023 (“Policy Address”), the Hong Kong Chief Executive officially proposed to establish a preparatory office for the Hong Kong Centre of Medical Products Regulation (“CMPR”). According to the Policy
As the new year approaches, companies conducting clinical trials in China may want to consider a new regulation that will become effective in March 2024. On November 3, 2023, China’s National Medical Products Administration (“NMPA”) issued a Guideline on Inspection of Drug Clinical Trial Institutions Conducting Studies (Trial Implementation) (“Inspection Guideline” or “Guideline”). The Guideline