CFDA to implement ICH guidelines

China FDA said it will adopt five safety and regulatory guidelines from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. The agency said this will further its goal of reforming its review and approval system to encourage the development of innovative drugs and devices.

Starting Feb. 1, CFDA will adopt a common technical document for submissions for certain therapeutics. The agency will also adopt ICH's guidelines for expedited reporting of clinical safety data before and after a drug’s approval as well as guidelines for individual case safety reports. In addition, CFDA will use the council's medical dictionary for regulatory activities. ...