China’s Food and Drug Administration (CFDA) has already started shifting multiple inspection and approval authorities to its regional FDA offices. The changes, mandated under the CFDA’s May 15, 2013 restructuring plan, are to be completed by the end of 2013 at the latest. Duties to be handled by regional FDA offices include:
- GMP certification for drugs and medical devices
- Drug registration renewal
- Change in approval for locally manufactured Class III in vitro diagnostic (IVD) reagents
- Change in approval for locally manufactured Class III medical devices
- Approval of applications for drug contract manufacturing
According to a CFDA notice released at the end of June, local FDAs were to begin GMP inspections of facilities manufacturing Class III medical devices and IVD reagents by July 1, 2013.
They are to begin authorizing changes in approval for locally manufactured Class III medical devices and IVD reagents by October 1, 2013. Such changes in approval include the name of the manufacturer and the address of the manufacturing location. Regional FDAs must publicly publish change notifications once every two weeks, and they must keep all records on file for no fewer than 16 years. All applications sent to the CFDA before September 30, 2013 will still be reviewed at the national level.