China’s Pharmaceutical Future – Both Complex and Growing

By: Howard Sklamberg, Richard Moscicki, M.D., and Alonza Cruse

中文(Simplified Chinese)

A visit to any one of the cities we visited on this trip – Shanghai, Nanjing and Beijing – would leave anyone marveling at the scale and trajectory of modern China. But it’s not just the sheer size of the population we were struck by. Rather, it was the seemingly tireless dedication to modernity that provided an almost palpable affirmation of what we already knew: that China — its skylines dotted with construction cranes and landscapes crisscrossed by high speed bullet trains — is inextricably connected with our own country’s economy, and increasingly with our agency’s ever-expanding regulatory mission.

Howard Sklamberg

Howard Sklamberg, FDA’s Deputy Commissioner for Global Regulatory Operations and Policy

We traveled to China for a few reasons. First, we wanted to gain more on-the-ground insight into how its drug industry works. We also wanted to offer some helpful perspective to Chinese regulators and drug companies about the Food and Drug Administration Safety and Innovation Act (FDASIA), which passed three years ago and is in the process of being fully implemented. In part, the law gave the FDA new authorities to ensure the safety of the global drug supply chain, in which China plays an enormous part. How enormous? After the United States, China ranks second for the number of FDA-registered drug establishments that the agency regulates, and is the sixth largest provider of drugs and biologics to the U.S.

Our itinerary also included a meeting with the Chinese Food and Drug Administration (CFDA) and a tour of a Chinese pharmaceutical manufacturing plant. And if you asked us what the most important by-product of our trip has been, it was these face-to-face conversations with our Chinese counterparts.

Specifically, we discussed the responsibilities of firms in the global drug supply chain. These days, the drugs we have in our medicine chests may seemingly come from one company, but the ingredients in them may actually come from numerous companies and countries. China is a major provider of many of the active ingredients in finished drug products Americans rely on every day.

Dr. Richard Moscicki

Richard Moscicki, M.D., FDA’s Deputy Director, Center for Drug Evaluation and Research

We had productive discussions with the Chinese about how seriously we are committed to making sure that everyone in the drug supply chain – from the companies that make the active ingredients to those that provide the packaging –shares in this collective commitment to quality. As we did when we spoke with our counterparts in India, we stressed that we apply the same quality and data integrity standards to all countries shipping drug ingredients into the United States.

We delivered the same message to a huge crowd of students at an event hosted by China’s Pharmaceutical University in Nanjing. In our remarks, we set forth our expectations for the delivery of drug quality, saying: “…ideally, our approach will complement the baseline, legal requirement of compliance with the higher bar of firms’ self-interest in being recognized for providing quality products and engaging in a different way with FDA.

While in Nanjing, we had productive discussions with students and stakeholders about FDASIA, quality in contract manufacturing, inspections, regulatory science, and expedited approval pathways that FDA is using to accelerate the process for making novel drugs available to patients.

Additionally, we toured a Chinese pharmaceutical facility and met with CFDA to discuss the revision of China’s Drug Administration Law, our own FDASIA implementation, regulatory science matters, as well as continued collaborative activities. We also had a productive roundtable discussion with leaders from 17 prominent Chinese pharmaceutical companies. We addressed pharmaceutical quality, data integrity, and the approval process for generic and innovator drugs.

Alonza Cruse

Alonza Cruse, FDA’s Acting Director, Pharmaceutical Quality Program, Office of Regulatory Affairs

As China’s role on the global stage expands, FDA has significantly increased drug and medical device inspections there, but we need to continue to strengthen our efforts. The Office of Regulatory Affairs and our China office have managed a large number of pharmaceutical inspections. 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 U.S.

Given the volume of U.S. 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.

FDA’s priorities in China match its global priorities: we work to ensure the safety and efficacy of FDA-regulated products. China’s size and relentlessly expanding economy have an increasingly significant impact on the products that Americans consume, particularly pharmaceuticals.

We trust our trip to China added to the growing collaboration between FDA and our counterpart agencies there, ensuring the safety of the pharmaceutical products exchanged between our two nations.

Howard Sklamberg is FDA’s Deputy Commissioner, Global Regulatory Operations and Policy
Richard Moscicki, M.D., is FDA’s Deputy Director, Center for Drug Evaluation and Research
Alonza Cruse is FDA’s Acting Director, Pharmaceutical Quality Program, Office of Regulatory Affairs

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