US, Chinese regulators forge closer ties as FDA looks to triple staff

24-Nov-2014 - Last updated on 24-Nov-2014 at 15:14 GMT

Hamburg getting cozy with a Chinese official

Related tags Food and drug administration

As FDA commissioner Margaret Hamburg wraps up her trip in China it looks like the FDA is creating a stronger bond with its Chinese counterparts as the FDA looks to triple its staff there.

The FDA currently has eight staffers in China -- which is sixth among exporters of drugs and biologics to the US – but only one of those staffers is devoted to the inspection of drug manufacturing facilities, FDA spokesman Chris Kelly told In-Pharmatechnologist.

The addition of at least 18 new staffers should help the agency conduct more inspections in a country that is also the fourth largest API exporter to the US, behind Canada, the UK and India.

“The agency will increase its presence in China from 8 US direct hires to 26,” Kelly told us, noting the FDA hopes to add 10 more drug inspectors. “The FDA expects to receive the visas for the additional staff in the coming weeks and months.”

Kelly also told us that in order to meet the expanding Chinese marketplace, the FDA has sent US inspectors to China for between two and four months, though he could not provide any figures on how many inspections require these visits or how much they cost.

And although Hamburg didn’t comment directly on the visa situation, she did say in a blog post on Friday: “Given the volume of US trade with China, we are working to more than triple the number of American staff we place in China. Placing more FDA experts in China will allow FDA to increase significantly the number of inspections it performs.”

FDA inspections of drug manufacturing facilities in China have increased from 15 in 2000 to 117 already this year.

Pact and Training

Hamburg also signed an Implementing Arrangement with the China Food and Drug Administration (CFDA) and expects to sign a similar Implementing Arrangement with the General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ) in the coming weeks. The agreements build on 2007 agreements with the same two agencies and help to frame the work FDA inspectors will do in China and help to forge more collaboration on inspections.

“FDA is also engaging with other stakeholders to create sustainable models for training future champions of regulatory science and quality,” Hamburg writes. The agency helped to create a graduate degree program in international pharmaceutical engineering management (IPEM) at Peking University (PKU) in 2005.

Two courses on current good manufacturing practices “proved hugely successful, and drew attention from Chinese drug companies and regulatory agencies, as well as industry and regulators in neighboring countries,” she says, noting that PKU has now established a master’s degree program in IPEM, with support from FDA and multinational pharmaceutical companies.