Evaluating China's Supply Chain - Pharmaceutical Technology

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Evaluating China's Supply Chain
Increased pharmaceutical trade creates new challenges for regulatory oversight.

Pharmaceutical Technology
pp. s30-s36

Technical cooperation and capacity building. Part of FDA’s strategy also involves engaging in regulatory cooperation with other global partners. “The capacities of governments to manage, assess, and regulate products within increasingly complex supply chains are a fundamental factor affecting product safety and efficacy,” said Solomon in his testimony (1). “FDA is working strategically with a range of countries to provide information, tools, training, and exchange programs that contribute to building or strengthening regulatory capacity of our trading partners,” he added.

Implementing new laws. Solomon also pointed to recent legislation to facilitate FDA in its efforts, most notably, the Food and Drug Administration Safety and Innovation Act (FDASIA). With the passage of FDASIA in 2012, Congress granted FDA important new authorities, reauthorized human drug and device user fees, and authorized new user fees for generic human drugs and biosimilar biologics (1). From a FDA perspective, these authorities and fees are intended to maintain a predictable and efficient review process for medical products, provide incentives for developing new antibacterial and antifungal drugs, combat drug shortages, and enhance the agency’s efforts to ensure that US consumers have more timely access to safe, high-quality, and affordable medicines.

Title VII of FDASIA focuses on improving the safety and integrity of drugs imported into and sold in the US (1). The new authority increases FDA’s ability to collect and analyze data to enable risk-informed decision-making, advance risk-based approaches to facility evaluation, partner with foreign regulatory authorities to leverage resources through information-sharing and recognition of foreign inspection, and allow the use of other tools intended to improve quality throughout the supply chain (1). In his testimony, Solomon pointed to the law’s requirement that foreign and domestic companies provide information on threats to the security of the drug-supply chain and improvements to current registration and listing information.

FDA activities in China
With increasing overall trade with China, FDA is also faced with the challenge to provide strengthened oversight for products coming from China. During FY 2007–2012, the total number of shipments of FDA-regulated products from China increased from approximately 1.3 million entry lines to 4.5 million lines. Of the 4.5 million lines arriving from China in FY 2012, 67% were drugs and medical devices, and 6% were human food products. Approximately 5% of imports into the US of drug and biologics come from China (1).

Solomon noted that FDA has 13 officers posted in three locations in China: Beijing, Shanghai, and Guangzhou. This staffing includes eight US employees and five Chinese staff. The purpose of FDA’s China office is to strengthen the safety, quality, and effectiveness of FDA-regulated products produced in China for export to the US. Solomon noted several ways in which the agency is seeking to meet that goal. These efforts include: collaborating, capacity-building, and confidence-building with Chinese regulatory counterparts at the central, provincial, and municipal level; reaching out to regulated Chinese firms that wish to export their products to the US to enhance understanding of and compliance with FDA standards; monitoring and reporting on conditions, trends, and events that could affect the safety and effectiveness of FDA-regulated products exported to the US; conducting inspections at facilities that manufacture FDA-regulated goods; and increasing the knowledge base and understanding of key stakeholders about FDA regulations and science-based approaches to strengthen product safety, quality, and effectiveness (1).

In mid-April 2013, FDA met with the China Food and Drug Administration (CFDA) in Washington, DC to discuss the collaboration between FDA and CFDA across more than a dozen topic areas. “While much of the strengthening of our relationship with CFDA has come through day-to-day collaboration between FDA’s China office and CFDA officials in Beijing, there are other significant ties in multiple areas across our agencies,” said Solomon (1). These efforts include regular meetings with a CFDA and US working group on economically motivated adulteration. It also involves collaboration by FDA and CFDA in working under the auspices of the World Health Organization’s Working Group for Member States on Substandard, Spurious, Falsely Labeled, Falsified and Counterfeit Medicines (1). Solomon also said that FDA and CFDA inspectors regularly observe one another’s inspections. Additionally, in May 2013, FDA and CFDA cohosted a workshop to enhance collaboration in addressing Internet-based, illegal distribution of adulterated drugs (1).

Solomon noted other examples as well. Between 2010 and 2012, FDA held a series of workshops on good clinical practices for Chinese inspectors who inspect sites that conduct clinical trials to support the development of pharmaceuticals. “Prior to the workshops, CFDA had few well-trained inspectors able to conduct inspections of clinical research sites,” said Solomon, in his testimony. “FDA’s training in this area helped CFDA to establish its national clinical research inspectorate. FDA regularly invites these CFDA inspectors to observe agency [FDA] clinical research inspections in China to continue to enhance CFDA’s understanding of FDA requirements” (1).

Solomon also noted that at the request of CFDA, FDA’s China Office and Office of Criminal Investigations worked with US Internet-hosting companies to shut down 16 Chinese-language websites that illegally sold unapproved medical products through servers located in the US (1). Also, in 2012, CFDA provided to FDA’s China Office a list of Chinese pharmaceutical firms against which CFDA had taken regulatory action because of their failure to comply with relevant standards for good manufacturing practices. From the list, FDA identified 61 firms that had shipped products to the US and targeted these firms as priorities for inspection (1).

1. S. Solomon, “FDA’s Activities Related to China,” testimony before the Congressional–Executive Commission on China (Washington, DC, May 22, 2013).
2. Office of the President of the United States, “National Strategy for Global Supply Chain Security (Washington DC, January 2012).
3. FDA, Pathway to Global Product Safety and Quality (Rockville, MD, July 2011).


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