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, and Audrey Zhi

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

On April 26, 2023, the Shanghai Medical Products Administration (Shanghai MPA) issued the first customized cosmetics manufacturing license in China for a store in Pudong New Area (Shanghai MPA license).  Customized cosmetics are products that can be tailored to individual customer preferences and skin types onsite at a retail store, which an increasing number of

The State Administration for Market Regulation recently issued the Guideline on Law Enforcement for Using Absolute Terms in Advertisements (the “Guideline”), which provides guidance to regulators and companies on one of the most common issues of enforcement under the Advertisement Law. The Advertisement Law prohibits use of absolute terms like “highest level,” “best,” “first,” and

China has increasingly enacted laws and regulations that hold individual company employees accountable for serious food, drug, medical device, and cosmetic regulatory violations, such as those related to safety.  Consistent with this trend, on September 26, 2022, the State Administration for Market Regulation (SAMR) issued the Provisions on the Supervision and Administration of Implementation of

On September 2, 2022, China’s National People’s Congress Standing Committee passed the newly revised Agricultural Products Quality and Safety Law (the “Revised APQSL”).  The Revised APQSL went into effect on January 1, 2023.

The Revised APQSL regulates primary agricultural products derived from crops, forestry, livestock, and fisheries, including plants, animals, microorganisms and their products obtained

On June 8, 2022, China’s National Medical Products Administration (“NMPA”) issued the Rules on the Administration of Vaccine Manufacturing and Distribution (“RAVMD”), a new implementing regulation for the Vaccine Administration Law (“VAL”). The RAVMD went into effect immediately upon issuance, with no apparent grace period.[1] The RAVMD is part of a continuing

China’s State Administration for Market Regulation (“SAMR”) recently issued Administrative Measures for the Supervision and Inspection of Food Production and Distribution (the “Measures”), which took effect on March 15, 2022.[1]  The Measures implement manufacturing and distribution requirements in China’s Food Safety Law and build upon the 2016 version of the measures on routine inspections

On November 16, 2021, SAMR released for comment draft regulations entitled “General Rules for Food Manufacturing License Review (2021)” (the “2021 Draft” or the “Draft”). The 2021 Draft sets forth the license review scheme for food varieties that are difficult to classify, such as new food raw materials or foods in new forms that emerge

China’s State Administration for Market Regulation (“SAMR”) recently issued Measures for the Administration of Lists of Serious Illegal and Dishonest Acts (the “Measures”). These Measures, which took effect on September 1, 2021,[1] were promulgated to standardize the management of lists maintained by market regulation authorities of parties that have committed serious violations of law

China’s General Administration of Customs recently promulgated new Measures on the Administration of Import and Export Food Safety (the “Measures”), which will take effect on January 1, 2022.[1]  The Measures integrate five individual inspection and quarantine regulations (to be abolished when the Measures take effect) for import and export of special categories of foods,