FDA commish to talk drug safety at China regulatory chief confab
- FDA Commissioner Margaret Hamburg is heading to China for the International Summit of Heads of Medicines Regulatory Agencies.
- Safety in China has been a big FDA priority since 2008, when Chinese-made crude heparin was tied to the deaths of dialysis patients.
- Since 2008, the FDA has been increasing its presence in China, including by expanding the number of FDA operational employees in the country from 13 to 34 (there are more than 1,000 FDA-trained inspectors in China). One major challenge is getting the requisite visas for FDA employees.
As the country that dominates the active pharmaceutical ingredient (API) market, China plays an critical role in the global biopharma marketplace. However, safety continues to be a concern. In recognition of the value of face to face discussions, Commissioner Hamburg will be discussing drug safety and the best ways to facilitate the necessary documentation needed to bring additional FDA employees to China.
Commissioner Hamburg made a similar visit to India earlier this year, urging government officials there to comply with manufacturing standards in light of continued recalls of Indian-manufactured drugs.