Report: China to restructure its FDA

China is looking to restructure its Food and Drug Administration, according to a new report from the Regulatory Affairs Professionals Society.

With the reorganization, the CFDA will cease being a standalone department and will become part of the country’s National Market Supervision Association, according to the report.

The CFDA group is slated to add an additional 100 new individuals focused on regulating devices, and will drop its oversight of food, according to the report. The CFDA will also pursue increased inspections of foreign entities and penalties for noncompliance.

“​Previously, the registration of medical device and pharmaceuticals had to go through the Administration for Industry & Commerce, which was also partly conducting administrative penalties; Administration of Quality Supervision, Inspection and Quarantine, which was responsible for inspection and quality issues. Now they are supposed to be integrated as a whole,” China Med Device’s Leon Lei said, according to RAPS.

The CFDA is also looking to create systems to enforce manufacturer compliance of adverse events, according to the report..

The restructuring is not expected to impact device or pharmaceutical approval timelines, according to China Med Device CEO Grace Fu Palma, but will shift the group’s focus from approval to the lifecycle of product, RAPS reports.

What will affect day-to-day work, and possible approval times, are previously announced efforts to increase transparency around regulatory decision making, according to the report.

The CFDA is also looking to be more receptive to feedback from US and multinational companies who want to establish a formal channel for such feedback, and work with companies to improve approval timelines, RAPS reports.

“The government is spending tens of millions of US dollars to renovate their systems to make them more transparent … but timelines [to approval] are not coming down in the immediate future,” China Med Device’s Palma said, according to the report.

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