FDA Officials Comment on China Visit

In a blog posted on FDA’s website, top FDA officials present an update on China’s pharmaceutical industry and FDA’s involvement in helping keep the country’s pharma exports safe. The trip to China was made by Howard Sklamberg, FDA’s deputy commissioner for Global Regulatory Operations and Policy; Richard Moscicki, MD, FDA’s deputy director of the Center for Drug Evaluation and Research; and Alonza Cruse, FDA’s acting director, Pharmaceutical Quality Program, Office of Regulatory Affairs.

The FDA officials were in China to observe the Chinese drug industry and meet with representatives of the Chinese Food and Drug Administration (CFDA). They noted that the face-to-face meetings they had with CFDA were “the most important by-product of our trip.” The US FDA officials took a tour of a pharmaceutical manufacturing plant and addressed students at China’s Pharmaceutical University in Nanjing. The trip also included a meeting with 17 leaders of Chinese pharmaceutical companies to discuss quality, data integrity, and the drug approval process. 

Talks with CFDA included the importance of securing the global supply chain. The FDA representatives stressed that the agency applies “the same quality and data integrity standards to all countries shipping drug ingredients into the United States.” Discussions also included revisions to China’s Drug Administration Law, implementation of the US Food and Drug Administration Safety and Innovation Act, regulatory science issues, and the importance of collaboration.

The FDAVoice blog post also discusses FDA’s role in inspecting facilities in China and working with the local regulatory bodies. “Given the volume of US trade with China, we are working to expand our presence there to significantly increase the number of inspections we conduct. Staffing increases will allow FDA to enhance its training efforts and technical collaboration with Chinese regulators, industry, and others. In fact, in November 2014, we signed a Memorandum of Understanding with the Chinese government that expands our cooperation and will facilitate those staffing increases.”

The agency also reaffirms its commitment to keeping products safe when they are imported into the US. “The FDA’s office in China has also strengthened relationships with regulators and helped expand the country’s expertise in regulatory operations. And we have worked with industry and academia to explain our regulations and analyze trends and events that might affect the safety of FDA-regulated products exported from China to the US.”

Source: FDA.gov