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Western pharmaceutical groups are warning of worsening disruption to supply chains because of problems certifying manufacturing sites in China, with some factory inspectors refusing to visit the country over fears of arrest for spying and others denied entry to facilities.
China is one of the world’s largest makers of active pharmaceutical ingredients and antibiotics and a major supplier of drugs to the EU and US. However, a tightening of anti-espionage laws by Beijing has led to concerns that foreign citizens gathering data on Chinese sites could be deemed spies.
“A large number” of inspectors from Germany, Europe’s largest inspectorate, are refusing to visit China for fear of arrest, according to the German Medicines Manufacturers’ Association (BAH).
Meanwhile, official data seen by the Financial Times shows some US Food and Drug Administration inspectors have been refused entry to Chinese production sites since the pandemic.
This has led to western pharmaceutical regulators struggling to enforce oversight of Chinese manufacturers. Drugs made in third countries and imported into the EU or US require certification by government inspectors and audits of production sites.
Covid lockdowns, manufacturing issues and low prices have already contributed to record shortages of essential drugs in the US and Europe.
During the pandemic, some audits of Chinese sites were carried out online or certification was prolonged without inspection — meaning there is a large inspection backlog with many certifications due “to expire by the end of this year”, according to Fatima Bicane, manager of pharmaceutical technology at BAH.
Disruption to inspections increases the risk of Chinese production sites losing their certification for western markets, exacerbating an already strained supply chain for generic pharmaceuticals.
“The big issue we have is that our member companies, in order to bring active ingredients and finished drug products from China to the EU, need certification from certain authorities,” Bicane said. “But a large number of German inspectors are afraid to travel to China because of the new national security law”.
“Adrian van den Hoven, director-general of Medicines for Europe, an industry body representing European pharmaceutical companies, said that ambiguity around the new anti-espionage law had led to concerns that “an inspector . . . in China could be accused of espionage”.
Data from the US FDA shows that the agency’s inspectors began to be turned away from Chinese factories in 2021. In total there have been 150 incidences of refused FDA inspections since then. There were 26 inspection refusals last year, down from a peak of 62 in 2022
“When you talk about antibiotics, the Chinese are in a very critical position as most of the starting materials for antibiotics are made in China,” said Jim Miller, an industry consultant who advises on pharma manufacturing in the US. “The world is very dependent on China for antibiotic ingredients and active ingredients.”
No western pharmaceutical inspectors have been arrested for espionage under China’s tightened espionage laws. However, a Japanese executive from Astellas Pharma was arrested last year in China on suspicion of espionage.
A spokesperson for the German chancellery declined to comment on whether Olaf Scholz had raised the concerns of the German pharma industry with President Xi Jinping when the two leaders met in Beijing last week.
The FDA said it had conducted 420 inspections in China since 2019, using some officials stationed in China but mainly inspectors travelling from the US, adding that the number of annual inspections “may fluctuate year-to-year” based on the number of routine inspections or specific product applications.
A spokesperson for China’s Ministry of Foreign Affairs said: “China is a country ruled by law. All Chinese law enforcement and judicial activities are carried out based on facts and the law. As long as one abides by Chinese laws and regulations, there is no need to worry.”
Source: Economy - ft.com
