Medicilon's newly added facilities have obtained the GLP certification qualification of the National Medical Products Administration

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تصويت

On April 20, Medicilon Preclinical Research (Shanghai) LLC (MPR), a wholly-owned subsidiary of Shanghai Medicilon Inc. (Medicilon), has obtained the GLP (Good Laboratory Practice) certification of the National Medical Products Administration (NMPA) for the newly added facilities at Nanhui Park. In addition, Medicilon obtained two GLP certification approvals for the reproductive toxicity test (Stage III) and the carcinogenicity test qualification. Medicilon also passed the three-year regular review of NMPA drug GLP.

As of now, the service area of MPR GLP services has been increased from 8 to 9, which are single and multiple dose toxicity studies (rodent), single and multiple dose toxicity studies (non-rodent), reproductive toxicity test (Stage I, II, III), genetic toxicity test (Ames, micronucleus, chromosomal aberration), local toxicity test, immunogenicity test, safety pharmacology test, toxicokinetic test, and carcinogenicity test. The total GLP laboratory area of Medicilon increased from 11,000 square meters to 29,000 square meters. The newly added GLP certification is an important milestone in the 19-year development of Medicilon!

       ❖Medicilon's Drug Safety Evaluation

Medicilon has a quality management system for drug safety evaluation based on the internationally certified AAALAC quality standard and compliance with international and domestic GLP regulations.Since 2008, we have continued to meet international standards and completed high-quality GLP safety evaluation services, establishing a long-term brand effect. Medicilon can perform systematic evaluation services covering multiple toxicity endpoints and has internationally recognized pathology studies to support our safety evaluation studies.

In this rigorous and meticulous GLP certification inspection, the experts from NMPA highly recognized and praised the management system, scientific research personnel, experimental facilities, instruments and equipment, and the operation and management of projects of Medicilon GLP Laboratory. All the experts unanimously agreed to pass the Medicilon’s GLP test.

GLP is the standard that drug non-clinical safety research must abide by, and it is also the basis for international mutual recognition of drug research data. Medicilon’s wholly-owned subsidiary, MPR, is one of the earliest CRO companies in China to establish the preclinical animal experiment facilities in accordance with international GLP standards, and has obtained the certification of the International Laboratory Animal Assessment and Accreditation Committee (AAALAC) GLP certificate. Medicilon has also met the GLP standard of the US FDA and has rich experience in application for clinical trials in China, the United States, Australia and other places around the world.

Break through the situation with hard work and innovation, and empower R&D with dedication, Medicilon will continue to standardize the quality management of non-clinical drug research, through independent iterative innovation and benchmarking with international cutting-edge technology. Medicilon will also fulfill the responsibility and mission entrusted by the era of new drugs, and empower the development of the pharmaceutical industry!

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