The China Food and Drug Administration (CFDA) is to start running surprise inspections of manufacturers of drugs and medical devices starting 1 September. The policy is intended to allow CFDA to act faster and eliminate the opportunity for manufacturers to destroy evidence before its inspectors visit.

Xinhua published a brief summary of the policy, in which it outlined the process for surprise visits and how CFDA will decide which facilities to target. CFDA will assess tip offs from whistleblowers, reports of adverse events and other factors before deciding to conduct a surprise inspection, at which point it will mobilize its team without informing the manufacturer of its plans. Inspectors will then visit the plant and only communicate their findings once they have gathered all the evidence.

The effectiveness of the strategy depends on CFDA’s ability to stop news of its inspection plans leaking to companies ahead of its visits. Recognizing the potential for unscrupulous officials to give companies advance notice, CFDA has implemented disciplinary measures for anyone found to have leaked confidential information deliberately. When officials are suspected of criminal activity, CFDA will pass the cases to law enforcement.

CFDA will begin enforcing the new policy on 1 September, two years after it started reworking its approach to fix shortcomings with its existing strategy. Officials became frustrated with the timeliness, standardization and inter-departmental coordination of inspections conducted under the old approach. The new strategy is intended to address these topics, while also stopping companies from destroying evidence and taking other actions to hinder inspectors.

（SOURCE： Regulatory Affairs Professionals Society)