Major Restructuring of National Regulatory Technical System in 2026: NIFDC Renamed and CFSI Officially Established, Separating Food and Drug Regulatory Powers

On July 30, 2026, a landmark adjustment took place in China’s national food and drug regulatory technical support system: the former National Institutes for Food and Drug Control was officially renamed National Institutes for Drug Control (NIFDC, hereinafter referred to as "China National Institute for Drug Control"). Meanwhile, the brand-new China Food Safety Inspection Center (CFSI, hereinafter referred to as "National Food Safety Inspection Center") was formally established.

This adjustment is far more than a simple name change. It represents a deep clarification and functional reconstruction of the institutional positioning of the technical support institutions directly under the National Medical Products Administration, completely ending the historical overlap of food and drug regulatory technical functions that existed for many years. The two national-level "technical arbitration platforms" will now perform their respective duties independently, building two solid technical defense lines for public food and drug safety.

NIFDC: From "Food and Drug Control" to "Drug Control", Returning to the Position as the Supreme Arbiter of Drug Quality

By removing the word "Food" from its name, the renamed NIFDC will fully concentrate all its technical resources on the three core regulatory fields of pharmaceuticals, medical devices, and cosmetics, completely eliminating the previous semantic ambiguity between its old name and the current regulatory system. It now becomes the only exclusive national-level technical support institution for national drug regulation in China.

As the statutory institution and the highest technical arbitration body for the national inspection of drug and biological product quality, NIFDC now has its technical capabilities covering all core links throughout the entire life cycle of drugs from R&D and marketing to delisting. Its five core functions are clearly defined:

• Inspection, Testing and Arbitration: Undertake full-category inspection and testing of pharmaceuticals, medical devices, cosmetics, as well as pharmaceutical excipients and packaging materials and containers in direct contact with drugs, coordinate national drug quality sampling and quality analysis, and serve as the only statutory subject for drug re-inspection, technical arbitration, and import drug registration testing.
• Standards Development, Revision and Research: Take the lead in developing, revising and technically reviewing quality standards, technical specifications and inspection and testing methods for all categories of pharmaceutical products, and continuously carry out cutting-edge research on new inspection technologies, new methods and new standards. It is the "birthplace" of national drug testing standards.
• Safety Evaluation and Monitoring: Conduct traceability experimental research on serious adverse drug reactions and serious adverse events of pharmaceuticals, medical devices and cosmetics, coordinate the national medical device standard management, cosmetic safety technical evaluation, and batch release of all biological products.
• Reference Material and Culture Collection Management: Be responsible for the overall planning, research and preparation, calibration, distribution and full life cycle management of national drug reference materials nationwide, undertake the verification of production strains and cell lines, as well as the collection, identification, preservation and distribution of medical standard strains and cell lines.
• Technical Support and Talent Training: Coordinate laboratory comparison, proficiency testing, assessment and evaluation of national drug inspection and testing institutions, carry out postgraduate education and training related to pharmacy, and provide professional technical guidance and training for drug inspection and testing work across the entire industry.

From "Food and Drug Control" to "Drug Control", behind the simplification of the name, NIFDC’s positioning as the "supreme arbiter" of national drug quality has been further strengthened. In the future, its technical resources will be more concentrated and its professionalism will be further improved, building a more solid technical barrier for public drug safety across the country.

CFSI Officially Launched, Ten Core Functions Build a New Food Safety Technical System

With all food-related functions fully transferred from NIFDC, the newly established CFSI has become a brand-new core national-level technical support platform for food safety. Its ten core responsibilities cover the entire chain from inspection technology research to emergency response:

• Deepen cutting-edge technology research on food safety inspection and testing, focus on tackling screening technologies for adulteration, doping, unknown risk substances, etc., take the lead in the research of key technologies such as food supplementary inspection methods and rapid testing methods, and simultaneously carry out independent R&D of related inspection instruments and equipment.
• Carry out applied research on the HACCP (Hazard Analysis and Critical Control Points) system for food safety, systematically sort out the risks of the entire food chain, identify the core technical control points in the whole process of supervision and implement them in practical applications.
• Take the lead in theoretical research on food safety standards and relevant policies, carry out standardization research on new technologies in the food safety field, be responsible for the development of food testing reference materials, evaluation indicators and method verification, and provide professional opinions for the improvement of national food safety regulatory regulations.
• Coordinate the competency evaluation of national food safety inspection and testing institutions, build a unified national technical system for quality control and proficiency verification of food inspection laboratories, and undertake re-inspection and comparative verification of controversial test results from food safety inspection institutions.
• Exclusively undertake the registration acceptance, technical review of three categories of special foods including health food, formula food for special medical purposes and infant formula food, as well as all technical work related to the filing of imported health food.
• Undertake food safety sampling tasks in accordance with the requirements of national regulatory authorities, carry out in-depth analysis of sampling monitoring data and release authoritative information, and build a risk warning system fully adapted to the whole-process food safety supervision.
• Coordinate the construction of national food safety inspection technical capabilities, be entrusted to carry out the assessment and management of the national food safety inspector team, and provide full professional technical support for regulatory actions such as food safety flight inspections and system spot checks.
• Undertake the daily work of the Secretariat of the Expert Committee of the Food Safety Commission of the State Council, fully participate in food safety support for major national events, provide authoritative technical support for food safety emergency response and law enforcement inspections, carry out technical identification of food safety accidents, and release scientific and accurate authoritative information to the public in a timely manner.
• Coordinate scientific and technological cooperation, technical services, publicity and training, science popularization, international cooperation and transformation of scientific research achievements in the field of food safety.

• Undertake other relevant technical work assigned by the State Administration for Market Regulation.

Essential Guide for Industry Practitioners: Two Platforms with Clear Division of Labor, Notes for Subsequent Business Processing

After this adjustment is fully implemented, all business related to pharmaceuticals, medical devices, cosmetics reference material procurement, registration testing and technical arbitration will be submitted to the National Institutes for Drug Control uniformly. All businesses related to food and special food, including reference materials, inspection re-verification, proficiency testing and technical review, will be transferred to the CFSI for acceptance. The business entry, public account and certification subject of the two types of businesses have been completely separated. Industry practitioners should submit their applications to the corresponding correct subject in subsequent business applications to avoid problems such as application rejection and process delay.

The independent operation of the two national-level technical platforms marks that the national regulatory technical support system for the two livelihood fields of food and drugs has officially entered a new stage with more precise, professional and clearer powers and responsibilities.