Drug Safety Evaluation Basic Information

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Sino-foreign joint venture

• In 2008, Shanghai Medicilon Inc. and MPI Research (an American CRO specializing in non-clinical drug safety evaluation services) established a joint venture - Medicilon Preclinical Research. As part of the joint venture, MPI provided the American GLP system and standard operation procedures for research to Medicilon Preclinical Research. Scientists from MPI provided training sessions for Medicilon Preclinical Research employees, and completed many non-clinical drug evaluation research projects with Medicilon scientists and technicians for clients at home and abroad.

GLP certificate

• NMPA granted Medicilon Preclinical Research wasGLP certification in 2011, and passed the review for GLP. Its toxicological research data also meets GLP standards of both the FDA and the OECD.

AAALAC

• In 2009, the Medicilon’s preclinical research experiment facilities were granted AAALAC Accreditation, and then again in both 2012 and 2016.

Animal rooms

• Medicilon Preclinical Research has rooms for the following animals:
  Mice/rats: 13,000Rabbits: 400Guinea pigs: 400Non-human primates: 550Dogs: 700Miniature pigs: 100
  

Platform construction

• Technical Service Platform for Non-human Primate Bio-tech-based Drug Safety Evaluation in ShanghaiTechnical service platform for non-human primate experiment researchDrug discovery and screening platform based on protein crystallographyTechnical service platform for isotope drug metabolism research

Completed projects

• Since 2012, Medicilon Preclinical Research has completed over 30 outsourcing services for non-clinical drug safety evaluation and 800 toxicological services. The tests involve micromolecule drugs, bio-tech-based drugs, vaccines (monovalent and multivalent), Chinese medicines, and natural medicines.

Filing of new drugs

• Since 2012, Medicilon Preclinical Research has finished nearly 50 complete sets of application materials, as well as hundreds of individual toxicological cases for non-clinical safety evaluation outsourcing services. The data has been reported to the NMPA, FDA, and TGA for IND filing.

Relevant laboratories

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