On May 15, 2017, three AIER Eye Hospitals in Wuhan, Changsha and Guangzhou received the “National Drug Clinical Trial Institution Qualification Certificate” by China Food and Drug Administration (CFDA) for conducting clinical trials, officially became GCP qualified medical institutions.
GCP is the English abbreviation for Good Clinical Practice, which was promulgated in 1998 and has been successfully implemented for nearly 20 years in China. “Any new drugs in China must go through clinical trials approved by the CFDA, and the drugs must be proved safe and effective before going into market. These clinical trials must be performed in strict management practices to ensure that the trial process specifications are met, the results are scientific and reliable, and the participant’s right and safety are fully protected. As such, the requirements are very highly for medical institutions, medical workers and researchers responsible for the trial. For medical institutions, GCP certification can only be granted when every single condition meets the standards of the CFDA,” Said by Xilan Tang, the medicine division director of AIER Eye Hospital Group. She is also the Ophthalmic medicine group leader of hospital pharmacy professional committee of Chinese Medicine Society.
GCP certification paved the road for AIER to independently develop its own novel drugs for eye care. Subsidiaries in Europe and Unite State will provide clinical trials in China with abundant case data, research data, methods and experience, etc. It will significantly enhance AIER’s drug development and clinical research. Secondly, GCP certification will help researchers at AIER to access the latest international research materials more easily and earlier, and to have in-depth exchanges with domestic and foreign advanced institutions and experts, Thus, accelerated domestic clinical trials will quickly turn latest medical research and drug development into real benefit to our patients.