China National Institutes for Food and Drug Control selected our company's multifunctional chromatography cabinet.
Release Date:
2025-05-27 20:30
Introduction to the National Institutes for Food and Drug Control
The National Institutes for Food and Drug Control (hereinafter referred to as NIFDC) originated from the Institute for Drug and Food Control and the Institute for Biological Products Control, both established in 1950 under the Ministry of Health of the Central People's Government. In 1961, the two institutes merged to form the Institute for Drug and Biological Products Control under the Ministry of Health. In 1998, it was transferred in its entirety from the Ministry of Health to become an institution directly under the National Medical Products Administration. In 2010, approved by the Central Organization Department, it was renamed the National Institutes for Food and Drug Control, simultaneously operating as the Medical Device Standard Management Center of the National Medical Products Administration, and externally using the name "China Pharmaceutical Inspection Institute". In 2018, according to the reply from the Central Organization Department on the institutional establishment of institutions directly under the National Medical Products Administration, NIFDC (Medical Device Standard Management Center of the National Medical Products Administration, China Pharmaceutical Inspection Institute) was designated as a public welfare institution of Category II directly under the National Medical Products Administration (retaining the departmental director-general level).
NIFDC is the statutory and supreme technical arbitration institution for national inspection of drug and biological product quality. It primarily undertakes inspection and testing of food, drugs, medical devices, cosmetics, and related pharmaceutical excipients, packaging materials, and containers (hereinafter collectively referred to as food and drugs); organizes sampling and quality analysis of drugs, medical devices, and cosmetics; is responsible for relevant re-inspections and technical arbitrations; organizes registration inspections of imported drugs and post-market data collection and analysis; undertakes the formulation, revision, and technical review of quality standards, technical specifications, technical requirements, and inspection and testing methods for drugs, medical devices, and cosmetics; organizes research on new inspection and testing technologies, methods, and standards; undertakes experimental research on the causes of serious adverse reactions and serious adverse events related to products; is responsible for medical device standard management; undertakes batch release of biological products; undertakes safety technical evaluation of cosmetics; organizes the planning, research, preparation, calibration, distribution, and management of national standard materials; is responsible for the verification of strains and cell lines for production; undertakes the collection, identification, preservation, distribution, and management of medical standard strains and cell lines; undertakes the breeding, preservation, supply, and quality testing of laboratory animals and related products; undertakes inter-laboratory comparisons, proficiency testing, assessment, and evaluation for food and drug inspection and testing institutions; is responsible for postgraduate education and training, and organizes training and technical guidance for quality inspection and testing work of food and drug related entities subjected to.
Under the leadership and care of the Party and the government, and through the arduous efforts and diligent work of several generations, NIFDC has developed into a comprehensive inspection institution integrating verification, scientific research, teaching, and standardization research. It currently undertakes the work of 7 centers and key laboratories: National Research Center for Viral Hepatitis, National Medical Products Administration Bacterial Drug Resistance Surveillance Center, China Medical Bacterial Collection and Management Center, National Rodent Laboratory Animal Seed Center, National Laboratory Animal Quality Testing Center, National Narcotics Testing Laboratory, and Ministry of Health Key Laboratory for Biotechnological Product Testing Methods and Standardization.
NIFDC has established multiple quality management systems that meet international requirements, such as ISO/IEC 17025, 17043, 17034, and GLP. It has successively passed certification and accreditation inspections by multiple departments including the China National Accreditation Service for Conformity Assessment (CNAS), the China National Accreditation Service for Laboratories (CNAS), and the National Medical Products Administration, possessing all relevant national qualifications. It has also passed certification and accreditation inspections by international organizations and authoritative bodies such as WHO, The College of American Pathologists, and AAALAC, ensuring the orderly conduct and reliable results of various tasks including inspection and testing, standard reference materials, proficiency testing, and drug safety evaluation.
In the past 30 years, by implementing the strategies of "Talent-Driven Inspection" and "Science and Technology-Driven Inspection," NIFDC has achieved numerous pioneering scientific and technological results, receiving 34 national science and technology awards and over 200 provincial/ministerial-level awards. Among them, 6 were National First-Class Science and Technology Awards. "Research on Inactivated Vaccine for Epidemic Hemorrhagic Fever" and "Development of Attenuated Live Vaccine for Epidemic Japanese Encephalitis" received National First-Class Awards for Scientific and Technological Progress. NIFDC has conducted multi-channel, multi-field, and in-depth cooperation and exchanges with over 20 international organizations, countries, and regional food and drug inspection agencies, including the United Nations Development Programme, the World Health Organization, and the United States, United Kingdom, Canada, Japan, and Germany. In September 1980, it became a WHO Collaborating Centre for Drug Quality Assurance; in 2013, it successfully applied to become the first WHO Collaborating Centre for Biological Product Standardization and Evaluation in a developing country; and in 2017, it became a WHO Collaborating Centre for Traditional Medicine. Its inspection and testing capabilities in related product areas have gained international recognition, providing strong technical support for Chinese enterprises to join the WHO global procurement list for pharmaceuticals.
Looking to the future, NIFDC will be guided by Xi Jinping Thought on Socialism with Chinese Characteristics for a New Era, fully implement the "four strictest" requirements, uphold the principles of safeguarding the nation and being responsible to the people, and focus on building inspection and testing capabilities. It will strive to provide comprehensive support for drug regulation, promote industrial development, and ensure public health, thereby vigorously writing a new chapter for drug inspection and testing in the new era.
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