Chinese Anti-Espionage Law causes quite a Stir

As recently reported in our news item "Counter-Espionage Law: Do GMP inspectors no longer go to China?", 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.

After the Federal Association of Pharmaceutical Manufacturers (BAH) and the Handelsblatt took up the matter, another article on the subject has now appeared in the Financial Times, as CPHI Online reports.

Western pharmaceutical companies are concerned about the developments and fear problems when carrying out GMP audits in China - from denial of access to the risk of arrest. According to the report, many foreign pharmaceutical companies are now refusing to go to China for fear of accusations of espionage.

However, the EU regulatory authorities are also experiencing difficulties when inspecting Chinese manufacturing facilities. GMP certificates that are to be extended or newly issued are not being extended or issued. This threatens to exacerbate the already tense situation with existing supply difficulties and drug shortages.

What about other countries?

According to the report, US FDA inspections could not be carried out in over 150 cases since 2021 because they were rejected. And there has already been an incident in which a Japanese executive from Astellas Pharma was arrested in China.