China is an essential link in the global pharma supply chain as the key supplier of drug ingredients for the world's drugmakers. But the country's vast industry and hit-and-miss government oversight poses special challenges for drug regulators who too often find companies there skirting the standards they expect. For the second time this year, European regulators have put a halt on exports from a Chinese company that they discovered had serious problems.
The European Medicines Agency (EMA) banned a number of the sterile products made by China's Zhuhai United Laboratories after inspectors from Romania uncovered shortcomings in the company's aseptic manufacturing in a plant in Guangdong, China. The Romanians reported to the EMA that they found a company with a weak and ineffectual quality assurance operation that had failed to pick up issues with the plant's environmental monitoring and media fill validation, as well as aseptic facilities design and equipment.
Zhuhai United claims to be the world's largest manufacturer of the API for the antibiotic amoxicillin and it was the sterile versions of amoxicillin ingredients that the EMA took action against. It said they are sold not just in Romania but also in France and the U.K. Regulators from the European Commission give each other a heads-up about problems they find by sharing information through the EMA.
Earlier this year, inspectors from France reported they had discovered contamination problems at an iodine manufacturing facility operated by Huzhou Sunflower Pharmaceutical's in Huzhou, Zhejiang Province. They also uncovered problems with the company's purified water system and a piece of testing equipment that may have been put in the facility just for show. That also led to some products being banned.
Both Europe and the U.S. have taken steps to try to keep a closer eye on Chinese manufacturers. The EU now requires that all active pharmaceutical ingredients imported into Europe include documentation from regulators in the originating country that they meet EU standards. The FDA, which already has a small band of drug and food regulators in China, has been trying for several years to beef up its presence in the outpost. It plans to more than double its staff of 13 to 34. But China, which is not big on having U.S. inspectors in its companies, has frustrated FDA efforts by holding up visas for new inspectors. That leaves it having to spend extra money to pay the travel costs of sending inspectors from the U.S. or other countries where they are based.
- access the EMA notice here