On December 30, 2020, the State Administration for Market Regulation (“SAMR”) issued a three-year action plan for improving the quality and safety of dairy products in China (the “Plan”), reflecting China’s commitment to continue strengthening the regulatory and legal standards for dairy products, The Plan sets forth eight quantitative goals for the supervision of the quality and safety of dairy products, to be reached by 2023. A number of these goals are fairly general without further explanation in the Plan:

  1. The rectification rate of problems found during supervision and inspection will reach 100%;
  2. The implementation of hazard analysis and critical control point systems (HACCP) by dairy product manufacturers with an annual revenue greater than RMB 20 million (approx. USD 3.1 million) will reach 100%;
  3. The inspection and control rate of raw and adjuvant materials, key processes (e.g., production process, equipment, storage, and packaging), and products of dairy product manufacturers will reach 100%;
  4. The safety self-inspection rate will reach 100%;
  5. The rate of reporting risks discovered during inspections will reach 100%;
  6. The pass rate of the supervision and spot check assessment on food safety management personnel will reach 100%;
  7. The quality management system self-inspection and reporting rate of infant formula milk powder manufacturers will reach 100%; and
  8. The pass rate of dairy products supervision and sampling inspection will remain above 99%.

In addition to setting forth quantitative goals, the Plan proposes to amend the Regulation on Supervision and Administration of Dairy Quality and Safety (the “Regulation”), which sets forth a framework to ensure the quality and safety of dairy products. In doing so, SAMR will cooperate with the Ministry of Agriculture and Rural Affairs and the National Health Commission to revise relevant national standards for raw milk, sterilized milk, pasteurized milk, and infant formula, and it encourages industry associations to formulate group standards to improve dairy product quality and safety indicators.

The Plan directs lower level regulatory agencies to provide further implementation guidance, based on the development characteristics of the local dairy industry, see, e.g., the Shanghai Municipal Administration of Market Supervision notice released after the Plan.

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

John Balzano, Julia Post, Muyun Hu, Annie Wang, and Kaixin Fan

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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 biotechnology, pharmaceutical, medical device, and trade association clients on a variety of federal and state regulatory and compliance matters. In particular, Julia has experience in areas including biosimilars and interpretation and implementation of the Biologics Price Competition and Innovation Act…

Julia Post advises biotechnology, pharmaceutical, medical device, and trade association clients on a variety of federal and state regulatory and compliance matters. In particular, Julia has experience in areas including biosimilars and interpretation and implementation of the Biologics Price Competition and Innovation Act of 2009; human cells, tissues, and cellular and tissue-based products (HCT/Ps); market exclusivity; informed consent requirements; and pharmacy substitution practices.

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

Photo of Muyun Hu Muyun Hu

Muyun Hu advises multinational and Chinese companies on a range of regulatory, policy, transactional, and litigation matters. Her work focuses on the life science industry, particularly with regard to food, drug, medical device, cosmetic, and other regulated products.

Photo of Annie Wang Annie Wang

Annie Wang is an associate in the firm’s Washington, DC office, where she is a member of the Food, Drug, and Device and the Litigation and Investigations Practice Groups. She represents companies and trade associations on a range of regulatory, policy, and litigation…

Annie Wang is an associate in the firm’s Washington, DC office, where she is a member of the Food, Drug, and Device and the Litigation and Investigations Practice Groups. She represents companies and trade associations on a range of regulatory, policy, and litigation matters.