The New Drug Safety Evaluation Center (NDSEC) was established in 2001, and is linked to the Institute of Materia Medica. It has already obtained NMPA GLP certification, AAALAC certification, national measurement certification, and national chemical good laboratory practice (GLP) certification. The NDSEC conducts tests on acute toxicity, chronic toxicity, genetic toxicity, reproductive toxicity, local toxicity, immunotoxicity, pharmacological safety, carcinogenicity, and toxicokinetics under GLP conditions. The center also studies the mechanisms underlying toxicological effects and the establishment of new techniques and methods that focus on new antigen screening, phototoxicity, and respiratory system toxicity. The center’s main technological platforms include: facilities to fully evaluate the safety or toxicity of photosensitizers and the phototoxicity of drugs using cell-to-animal models; a facility to evaluate inhalation exposure to liquid, gas, or dry powder test materials; and an apparatus to set up dosing techniques for tracheal instillation. The center’s developmental and reproductive toxicology research provides clients with access to world-class scientific staff that is knowledgeable in the unique difficulties of development and reproduction in both small and large animals. Tests developed at the NDSEC include the embryonic stem cell test and thezebrafishdevelopmental toxicity test model for the detection of embryo toxicity/teratogenicity.
Strictly following up the objective, impartial and fair principle, NDSEC aims to provide sponsors with real, formed, standard new-drug safety evaluation reports of research data, to provide authentic experimental data and reports to the national drug administration department, dedicated to making contributions to standardization of the new-drugs’ R&D to enhance the level of drug research in China and keeping on earlier realization of internationalization.
