CFDA Joins ICH, Seeks Public Comment on Further Reforms

In May 2017, the China Food and Drug Administration (CFDA) issued four new draft policies, the latest in a series of regulatory reforms which began in 2015 to accelerate the review and approval, and improve the quality, of new drugs and medical devices, for public comment. In June 2017, ICH and the CFDA jointly announced that CFDA had joined ICH as a Member. “CFDA is continuing to enhance the regulatory standards and regulatory system to promote innovation to improve the drug R&D ecosystem and, ultimately, to improve the access of medicines to patients,” explains pharmaceutical industry veteran Dr. Ling Su, Director and Professor at the Institute of Drug Regulatory Science at Shenyang Pharmaceutical University, and a Venture Partner at Lilly Asia Ventures, in this Global Forum podcast. “The CFDA has clearly indicated that, by joining ICH, the CFDA will comply with the rules and principles of ICH. This new development aligns very well with CFDA’s intention to become more aligned with international standards.”