China to Conduct Surprise Inspections on Pharma Companies in September

Published By : 09 Jul 2015 | Published By : QYRESEARCH

China has announced on Wednesday that it will commence regular surprise inspections on pharmaceutical companies and medical device firms beginning from September 1, according to the China Food and Drug Administration.

A surprise check will be conducted without any prior notice to the firms. The law enforcement authorities conducting the check ups will not reveal any information regarding the process. Nor will the authorities disclose any problems or issues brought into notice during the inspection, the China Food and Drug Administration explained. 

After all the necessary information and evidence has been gathered and the nature of the issues been determined, local units of the China Food and Drug Administration will inform the required medical device manufacturers or pharmaceutical firms about instructions pertaining to rectification.

Unannounced inspections will also be conducted if the law enforcement authorities are either contacted by whistleblowers from the general public or if they themselves become suspicious about certain pharmaceutical companies or medical device manufacturers, the China Food and Drug Administration said on Wednesday.

The CFDA has also laid down certain restrictive rules on law enforcement officers associated with the drug administration. If any officer or authority is found deliberately giving out confidential information on informers or inspections, they will be subject to discipline. In addition, those who are suspected to be involved with acts of criminal nature will be transferred to other judicial departments. 

In January last year, the China Food and Drug Administration issued a set of guidelines for routine inspections on manufacturers of medical devices. The ‘Guide for Regular Site Inspections of Medical Device Manufacturers’ was designed to be used by local inspectors and authorities during inspection of medical device manufacturing sites. 

These set of guidelines included detail rules pertaining to all aspects of the inspection such as step by step process for conducting checks, credentials of the authorities and inspectors, content of the systems, background information of the company to be collected in advance, and materials to be examined. 
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