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.

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 

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

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

On October 19, 2023, China’s National Medical Products Administration (“NMPA”) published the Rules for Applicable Discretion of Administrative Penalties in Drug Supervision and Administration (the “Proposed Rules”) for public comment. The Proposed Rules largely retain the overall structure of the 2012 Rules for the Applicable Discretion of Administrative Penalties in Drugs and Medical Devices (the

Post contributed by guest blogger Miguel Kitamura of Kitamura Law. Not affiliated with Covington & Burling LLP.

Earlier this year, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) published guidance on the use of electronic informed consent in clinical investigations, entitled “Points to Consider for Informed Consent Using Electromagnetic Means in Clinical Trials and Post-marketing

On July 11, 2023, China’s State Administration for Market Regulation issued Detailed Rules for the Review of Meat Production Licenses (“Rules”).  The Rules overhaul the review rules last published in 2006 by strengthening equipment and facility requirements, introducing requirements on personnel management, and expanding requirements relating to quality management systems.  In China, each domestic