China Counterespionage Law changes – Concern for GMP Audits Read More..

China’s revision of counter espionage laws in April 2023, with enumeration of espionage activities extended to include Stealing, prying into, purchasing, or illegally providing … other documents, data, materials, or items related to national security and interests has concerns for GMP audits in the country for foreign companies and agencies. According to United States National Counterintelligence and Security Center (USNCS) the law has the “potential to create legal risks or uncertainty for foreign companies.

The law requires all citizens and organizations to support and assist the government’s counterespionage work and failure to do may incur severe consequences for both the organizations and the persons in charge of them. The law empowers national security agents to summon persons who violate this law and to question them for up to eight hours or more, and suspects can be barred from exiting the PRC and this applies to foreigners as well.

Apparently, these changes are having an impact on the GMP inspections in China by foreign bodies as the risk to auditors have increased. In a letter to FDA the Republican members of a committee of US Congress, the Committee on Energy & Commerce, also asked FDA implications of China’s National Security Law on FDAs GMP inspection plans in China and actions FDA can take if inspectors are detained, arrested or prevented from completing inspection.

Related Article: China tightens Counterespionage Law – Risk for Audits and Inspections?