FDA Outlines Activities for Drug Inspections and Staffing in China

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 04-08-2014 10:36

Christopher Hickey, Country Director for the People's Republic of China with FDA, testified before the US-China Economic Security Review Commission on April 3, 2014, to outline the agency's role in inspections and related activities for drugs and new efforts by the agency to apply more resources to regulatory oversight there.

Approximately 40% of finished drugs in the United States come from overseas, as well as more than 50% of all medical devices.  Approximately 80%  of the manufacturers of active pharmaceutical ingredients (APIs) are located outside the United States. Hickey outlined that FDA has a permanent FDA presence overseas in 11 foreign posts in eight countries. It overseas officials are posted in China, India, Latin America, Europe, and South Africa. Establishments that are involved in the production and distribution of medical products intended for use in the United States generally are required to register annually with FDA.  In the years spanning FY 2007 and FY 2013, the total number of shipments of FDA-regulated products from China increased from approximately 1.3 million entry lines to 5.16 million lines.  Of the 5.16 million lines arriving from China in FY 2013, almost 25,000 lines were drugs and biologics and 3.4 million lines were medical devices—the majority of these (96% were Class I or Class II medical devices, including surgical drapes and gowns, syringes and tubing, graduated medication containers, and gloves.He outlined that  all FDA-regulated products originate from more than 200 countries and are marketed through more than 300 US ports. An entry line represents each portion of a shipment that an importer lists as a separate item on an entry document. Entry lines do not have a direct relationship with the actual number of imported items.  Some entry lines may represent one item, while others may represent thousands.  This is a known limitation of the data in FDA import systems because import filers are not required to declare volume per line and there is no standard format for declaring volume. 

Hickey also outlined drug inspections in China. In 2010, FDA conducted 46 drug inspections in China; in 2011, that number increased to 88; in 2012, FDA conducted 58 drug inspections; and in 2013, the agency conducted 84 such inspections. The majority of the drug inspections FDA conducts in China focus on manufacturers of APIs intended for use in generic drugs and on sites that produce over-the-counter drugs.  

FDA currently has 13 staff in China, posted in Beijing, Shanghai, and Guangzhou.  This includes eight US civil servants and five Chinese staff. Using funding Congress provided in 2013, FDA is currently working to increase to 27 the number of US officers it posts in China. 

In addition to other budget requests that focus on imports from China, the agency’s FY 2015 budget has requested $10 million in funding specifically for continuing its efforts in China. Hickey outlined that these new resources would do the following:

  • Strengthen FDA’s inspectional and analytical capabilities by adding nine drug inspectors to FDA’s China Office.  The United States and China were able to address problems associated with visas for these staff during the visit of Vice President Biden to Beijing in December 2013, and FDA anticipates posting these new staff in country in Fiscal Years 2014 and 2015. "This will allow more rapid access to Chinese facilities and will help to increase the number of FDA inspectors who have in-depth knowledge and expertise about current challenges that Chinese industry faces," he said

  • Broadening the range of inspections FDA performs in China.  In addition to inspecting Chinese facilities that manufacture food and medical products for export to the United States, FDA will increase the number of sites it inspects that conduct clinical trials pursuant to investigational new drug (IND) applications and will also perform follow-up inspections to ensure that firms continue to produce and manufacture food and medical products under safe conditions.

  • Increasing opportunities for engagement with Chinese regulatory counterparts.  Direct observation of FDA inspections can bolster Chinese regulators’ understanding of FDA’s requirements and processes and strengthen China’s inspectional capacity.

  • Enhancing Chinese regulators’ knowledge of US safety standards through participation in workshops and seminars, such as the International Conference on Harmonization and the International Pharmaceutical Regulators Forum.  "These opportunities help facilitate dialogue and encourage scientific exchange on the critical role inspections play in improving the safety and quality of food and medical products."

  • Strengthening FDA’s ability to use informatics tools, such as trend analysis, predictive modeling, and geospatial mapping.  "These tools will help to sharpen FDA’s understanding of potential public-health risks," he said. "Increased use of data will help FDA strengthen its systems in several key areas, including the implementation of science-based, harmonized standards. The ultimate goal is to detect and address risks through preventive, risk-based approaches before those risks result in harm to US consumers.

Hickey also addressed the status of China's good manufacturing practices (GMPs). In 2011, China's State Food and Drug Admistration (SFDA) published new requirements for GMPs—standards that were widely viewed as a significant step forward.  By the end of 2013, China Food and Drug Administration (CFDA) had made numerous strides in implementing these requirements, but significant work remains. "Like many Chinese Government ministries, CFDA also faces significant challenges as it works to balance the role of central and provincial authorities," said Hickey. "CFDA will continue to work for some time to develop sufficient technical and scientific depth to address China’s current challenges."

Hickey outlined progress made with CFDA. "In 2009 and 2010, as SFDA worked to reform its GMP regulations for drugs, it sought out FDA’s input into its draft regulations.  The FDA China Office, working with experts in FDA’s Center for Drug Evaluation and Research, provided feedback on these draft provisions and saw significant elements of FDA’s suggestions incorporated into SFDA’s new standards, which were published in 2011.  When CFDA went to implement these standards, an expert from FDA’s China Office conducted training for over one thousand Chinese inspectors on how to conduct inspections against such standards."

In the area of inspections and enforcement, Hickey said FDA has made significant progress with CFDA as well. CFDA inspectors regularly observe FDA inspections in China.  Since 2012, FDA’s Office of Criminal Investigations has worked closely with CFDA to enhance US-China collaboration in the fight against Internet-based, illegal distribution of adulterated drugs. "In recent years, CFDA has taken initial steps to learn about the requirements to join the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S), an international organization consisting of 44 member regulatory agencies (including FDA) and partner organizations, such as the World Health Organization and the United Nations Children’s Fund, which oversee the manufacture of pharmaceutical drugs imported into their regions. FDA has met with CFDA on several occasions to explain the PIC/S accession process and what is needed to apply and become a member.  PIC/S’ Secretariat has also encouraged CFDA to participate in PIC/S’ international training programs," said Hickey. He also pointed to the US-China initiatives to address economically motivated adulteration.

Source: FDA


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