Inspection Results and Penalties
Wang says the government’s inspection results include (i) “pass,” (ii) “corrective action,” and (iii) “fail.” Penalties include corrective actions, warning letters, suspension of import and sales, product recall and rejection of product license renewal.
“In practice,” she writes, “most manufacturers have been required to take corrective actions in order to close deficiencies. For severe deficiencies, the NMPA would order manufacturers to suspend importation and sales of their products in China. Since the end of 2018, the NMPA has banned importation of 19 drug products and two devices that were affiliated with severe deficiencies.”
Wang adds that while domestic Chinese drug and device manufacturers have been frequently inspected by the government, foreign manufacturers experienced a “much lower” frequency of inspections. But the announcement of the new regulations signals the government’s desire to treat foreign and domestic companies equally.
She advises drug and device companies to carefully study the statutory requirements and standards, perform internal audits on the relevant facilities, and identify and close potential gaps as soon as possible to mitigate enforcement risks.
You can reach Ms. Wang at Katherine.Wang@ropesgray.com
