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 food manufacturing facility must have a manufacturing license in a category that is appropriate for the products produced there.  The Rules are applicable to the examination of food manufacturing licenses for the category of meat products that use livestock and poultry as primary raw materials, and do not apply to production licenses for plant-based meat.

The Rules set forth requirements for various categories of review for licensure, including:

  • The production site, which addresses requirements for space, height, lighting, ventilation, sanitation, etc.;
  • Equipment and facilities, which addresses requirements for sterilization equipment, storage equipment, drainage facilities, mechanical exhaust facilities, testing equipment, etc.;
  • Equipment layout and process flow, which addresses specific requirements to avoid contamination of frozen meat, packaging, pickled and fermented meat products, products using thermal processing technology, etc.;
  • Personnel management, which addresses requirements for food safety management, personnel responsible for cleaning and disinfection, food processing personnel, training plans, health checks, etc.;
  • Quality management systems, which addresses processes for procurement management, production process control system, sanitation management, inspection management, etc.

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

John Balzano, Julia Post, Muyun Hu, Kaixin Fan, and Kexin Yang.

Photo of John Balzano John Balzano

John Balzano represents companies and business associations on U.S. and China regulatory and policy matters related to food, drugs, medical devices, cosmetics, and other regulated products.

John has over a decade of experience with legal and regulatory issues related to China, particularly with…

John Balzano represents companies and business associations on U.S. and China regulatory and policy matters related to food, drugs, medical devices, cosmetics, and other regulated products.

John has over a decade of experience with legal and regulatory issues related to China, particularly with regard to products regulated by the State Administration for Market Regulation, the National Medical Products Administration (NMPA), and other agriculture, animal and healthcare (including digital health) products and services. He assists clients with developing strategies to obtain pre-market approvals for these products in China, including clinical development, understanding relevant pricing and reimbursement policies, and reviewing distribution and promotional plans.

He also advises on regulatory compliance, due diligence, and enforcement matters for China operations, including drafting and revising and integrating China and global standard operating procedures, assessing the functions of regulatory departments in China, responding to inspection results and enforcement inquiries, and implementing product recalls. John also has significant experience designing strategies to handle professional consumer litigation for food and cosmetic companies operating in China and working with local counsel.

He advises companies and industry associations on their advocacy strategies, including the notice and comment process before NMPA and other regulatory agencies.

John has particular experience in the U.S. advising on the requirements for the acquisition and transfer of biospecimens for research purposes.

Photo of Julia Post Julia Post

Julia Post advises companies and trade associations on a broad range of regulatory and policy matters related to drugs, biologics, and other regulated products in both the U.S. and China. Julia has significant experience in advising clients on clinical trial and product development…

Julia Post advises companies and trade associations on a broad range of regulatory and policy matters related to drugs, biologics, and other regulated products in both the U.S. and China. Julia has significant experience in advising clients on clinical trial and product development matters, including informed consent requirements, biospecimen procurement and research use, and other good clinical practice. She advises clients regularly on product life-cycle management issues, including patent linkage frameworks and marketing exclusivity in the U.S. and China.

Julia works with pharmaceutical, medical device, food, and cosmetics clients on complex regulatory compliance matters and helps them develop their advocacy strategies before U.S. and China regulators, at both national and local levels. She regularly assists companies and trade associations on policy issues, including the development and submission of comments on legislative and regulatory proposals. Julia works closely with local counsel throughout the Asia-Pacific region to assist clients with their marketing approval and compliance strategies.

Prior to joining the Food, Drug, and Device practice group, Julia was a member of the Litigation practice group where she focused on representing clients in Hatch-Waxman patent litigation.

Julia has an active pro bono practice at Covington, with a particular focus on reproductive justice matters and representation of third-party caregivers and children in custody cases.