Chinese FDA reports on foreign drugmaker inspections

The Chinese Food and Drug Administration has released its annual report detailing findings from inspections of drug manufacturing sites around the world in 2016.

China’s FDA says it conducted overseas inspections in 19 countries for imported pharmaceuticals last year, mostly in Europe and North America. These inspections covered 15 varieties of pharmaceutical products.

The report shows that three companies failed to meet the body’s inspection criteria, a higher rate than in previous years. Eight companies withdrew their import registration certificates or had their applications returned during the inspections.

Ding Jianhua, a director at the CFDA, said: "One manufacturer from a European Union country didn't report to the CFDA their major changes and even added some APIs, active ingredients to their production. They didn't report the source of these materials, and we stopped their importation.”

The agency says that China received inspections from more than 80 foreign countries last year, resulting in nine companies being found with critical deficiencies.

Manufacturers of traditional Chinese medicines were said to fail more frequently than other drug categories.

Ding Jianhua said: "There's a worldwide understanding that if an authority can find more problems, it proves the agency is highly-qualified. Our role is to find problems. Our inspectors are trained to find weaknesses, and prevent them from recurring.”

The organization says these exchanges can help improve its drug administration by strengthening inspection of domestic drugs.