SaiFu Pharma's Nonclinical Safety Evaluation Center Receives Full GLP Certification for Nine Test Categories from China's NMPA

On November 20, 2019, Guoke Saifu Hebei Pharmaceutical Technology Co., Ltd. (Saifu Pharmaceutical Safety Assessment Center) obtained nine approval documents for full-scope safety assessment test qualifications issued by the National Medical Products Administration.

In October 2019, the Center for Food and Drug Inspection of the National Medical Products Administration organized experts to conduct a systematic on-site Good Laboratory Practice (GLP) inspection at Guoke Saifu Hebei Pharmaceutical Technology Co., Ltd. The inspectors rigorously reviewed the Safety Assessment Center’s organizational structure and personnel, test facilities, quality assurance system, and study operations, granting high recognition to the Center’s GLP system and standardized management.

In October 2019, the Center for Food and Drug Inspection of the National Medical Products Administration organized experts to conduct a systematic on-site Good Laboratory Practice (GLP) inspection at Guoke Saifu Hebei Pharmaceutical Technology Co., Ltd. The inspectors rigorously reviewed the safety assessment center’s organizational structure and personnel, testing facilities, quality assurance system, and study operations, granting high recognition to the center’s GLP system and standardized management.

This marks the establishment of Hebei Province’s first laboratory capable of conducting nine Good Laboratory Practice (GLP) studies and its first laboratory equipped for primate research. It is also a national non-clinical drug evaluation and research center with technical capabilities to assess traditional Chinese medicines, chemical drugs, and biopharmaceuticals, featuring specialized expertise in evaluating the dependence potential of psychotropic and neurological drugs, cell-based therapies, and pediatric medications, thereby serving pharmaceutical enterprises in their drug R&D efforts across China and worldwide.

Regarding the Good Laboratory Practice (GLP) Certification for Non-clinical Drug Studies by the National Medical Products Administration

GLP certification refers to the inspection by national drug regulatory authorities of non-clinical safety evaluation research institutions regarding their organizational structure and personnel, facilities, instruments and equipment, experimental materials, and implementation of research activities, as well as the assessment of their compliance with GLP requirements.

Established in 2017 and commencing trial operations in July 2018, the facility has constructed a 7,500-square-meter functional laboratory and experimental animal housing infrastructure in accordance with the most advanced international concepts of zoned control. It is primarily engaged in non-clinical safety evaluation studies of pharmaceuticals (biologics, chemical drugs, and traditional Chinese medicines), medical devices, food, and chemicals under Good Laboratory Practice (GLP) conditions, as well as GLP-compliant pharmacological, efficacy, and pharmacokinetic studies. Adhering to the GLP standards of the National Medical Products Administration (NMPA), the Organisation for Economic Co-operation and Development (OECD), and the U.S. Food and Drug Administration (FDA), the center is capable of concurrently conducting comprehensive non-clinical safety evaluation studies for dozens of pharmaceuticals or medical devices. The center employs numerous drug review experts, GLP inspection specialists, and medical device evaluation experts. Its core personnel have successfully completed approximately 1,200 pharmacological, efficacy, and toxicological evaluation projects both domestically and internationally, all of which have successfully passed NMPA or FDA reviews.

Saifu Pharmaceutical Group is committed to becoming a world-class, one-stop pharmaceutical CRO service provider. The company comprises technical departments specializing in pharmaceutical R&D consulting, pharmacology and efficacy evaluation, drug metabolism analysis, pharmaceutical formulation, toxicology and safety assessment, bioanalysis, generic drug consistency evaluation, Phase I clinical trials, and post-marketing re-evaluation. It delivers comprehensive, one-stop professional services for pharmaceutical R&D enterprises. Saifu Pharmaceutical has been honored with titles such as National High-Tech Enterprise, Beijing Technology-Based Small and Medium-sized Enterprise, and Zhongguancun High-Tech Enterprise.The group operates the Jingnan Gu’an Drug GLP Center, the Shenzhen Druggability Evaluation Center, the Beijing Physicochemical Testing and Clinical Evaluation Center, and the Benxi Small Molecule Bioanalysis Center. Additionally, it has co-established a Drug Testing and Analysis Laboratory with Shandong University and independently built four GCP clinical trial bases affiliated with Grade 3A hospitals.

Saifu Pharmaceutical Group is committed to becoming a world-class, one-stop pharmaceutical CRO service provider. The company comprises specialized technical departments including pharmaceutical R&D consulting, pharmacology and efficacy evaluation, drug metabolism analysis, pharmaceutical formulation, toxicology and safety assessment, bioanalytical testing, generic drug consistency evaluation, Phase I clinical trials, and post-marketing re-evaluation. Saifu provides comprehensive, one-stop professional R&D services to pharmaceutical enterprises. The company has been honored with titles such as National High-Tech Enterprise, Beijing Technology-Based SME, and Zhongguancun High-Tech Enterprise.Saifu Pharmaceutical operates the Jingnan Gu’an Drug GLP Center, the Shenzhen Druggability Evaluation Center, the Beijing Physicochemical Testing and Clinical Evaluation Center, and the Benxi Small Molecule Bioanalysis Center. Additionally, it has co-established a Drug Testing and Analysis Laboratory with Shandong University and independently built four GCP clinical trial bases at Grade A tertiary hospitals.