Counter-Espionage Law: Do GMP inspectors no longer go to China?

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15-17 May 2024
Berlin, Germany

The GMP-Auditor
Initial and Continuous Professional Training for GMP Auditors

As we reported at the end of last year, China has revised its counter-espionage law. Compared to the previous version, the new version expands the government's powers to combat espionage and emphasises the role of the public in this task. In theory, activities carried out as part of an audit or inspection can now also be punishable by law. Espionage suspects may be prevented from leaving China by order of the national security authorities at provincial level or higher. This provision also applies to foreigners.

Now, following the German Medicines Manufacturers Association (Bundesverband der Arzneimittel-Hersteller, BAH), the Handelsblatt (a German business and financial newspaper) has also taken up the matter. The article "Antibiotics: Pharmaceutical inspectors no longer dare to visit China" ("Antibiotika: Pharma-Inspekteure trauen sich nicht mehr nach China"), Handelsblatt, 10 April 2024, reports on the potential impact of the stricter security laws in China on inspections and audits by German authorities and pharmaceutical companies. These laws, in particular the anti-espionage law, are quite vaguely worded, meaning that any information gathering could potentially be criminalised, causing uncertainty among foreign companies. In particular, this may affect inspection and audit activities in China. And inspections and audits that are not carried out could further exacerbate bottlenecks in the supply of medicines in the EU.

According to research by Handelsblatt, German GMP inspectors, who normally inspect production facilities on site in China and then issue GMP certificates, have already partially suspended their activities due to fears of problems.

The German Medicines Manufacturers Association (BAH) has appealed to Federal Chancellor Olaf Scholz to address the problem during his visit to China and find a solution. One possible solution could be a "Letter of Intent" in which the Chinese government clarifies that the data collected during GMP-inspections does not fall under the anti-espionage law.