IPEC e-newsletter - Excipients Insight March 2018 - 28-03-18


Inside this issue


China shakes up its regulatory structure

The regulatory environment for pharmaceuticals in China is heading for another shake-up thanks to a restructuring of the five-year-old China Food and Drug Administration (CFDA).

A report in the FiercePharma industry newsletter, citing comments made at the Chinese State Council annual conference, says that the CFDA will merge into a bigger national body that will also focus on business registration, quality control, pricing and anti-monopoly efforts. It says drug regulation will be separated from food regulation and will operate as a “second-tier bureau” underneath the overarching agency.

The structure of the regulator has undergone several changes since it was set up in 1998 as the State Drug Administration (SDA), evolving into the State Food and Drug Administration (SFDA) and CFDA before the latest restructuring.

It appears that the latest change will have a more profound impact on the food industry but less so on pharmaceuticals, where regulatory reforms are already well advanced with a lot of new regulations already adopted and implemented, including the centralization of drug applications and approvals.




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