Regulatory Matters: What you should know about new FDA Supply ChainSecurity regulations

Last week, the European Medicines Agency sent warning letters to healthcare professionals across Europe about falsified and/or tampered vials of Herceptin, Roche’s potent drug for breast cancer. It appears that the vials were stolen in Italy, had their lot numbers modified, and reintroduced into the supply chain.

This is a growing problem, not only in the EU, but in the US as well. In response to the growing threat of counterfeit, adulterated, stolen and diverted medications entering the pharmaceutical supply chain, the US Food and Drug Administration (FDA) has implemented several important regulations highlighted within the Drug Supply Chain Security Act and the FDA Safety and Innovation Act (FDASIA).

As with any global enterprise, the risks of maintaining supply chain integrity from manufacturing to distribution across international borders are massive. These risks are multiplied when we’re talking about a nearly trillion dollar industry and where a breakdown can mean injury or death. The FDA estimates that 40% of finished drugs and 80% of active ingredient precursors are imported and has defined a rigorous process of inspections with the stated goal of preventing any type of illegal activity within the supply chain.

VII of the FDASIA signed into law in 2012, grants the FDA new authority to address these new challenges and better ensure the safety, effectiveness and quality of drugs imported into the United States. As stated on the FDA’s website,”>Implementation of these authorities will significantly advance its globalization and harmonization strategies and support FDA’s ongoing quality-related initiatives.

Further, these authorities will allow FDA to collect and analyze data to make risk-informed decisions, advance its risk-based approach to facility oversight, strengthen its partnerships with foreign regulators, and drive safety and quality throughout the supply chain through strengthened tools. At the same time, implementation of Title VII of FDASIA is difficult and complex, and requires not only the development of new regulations, guidances and reports, but also major changes in FDA information systems, processes and policies.”

Pharmaceutical companies and API manufacturers will need to become familiar with these regulations and determine how to leverage existing or implement new technologies to interface with the FDA. These include registration and listing of all drug/excipient manufacturers and importers. One critical aspect of Title VII is outlined in Section 706 which speaks to the types of records required by the FDA and timelines to produce the records prior to an inspection or audit.

Having a robust document and records management and recovery strategy has always been important, but under these new guidelines, getting the right information quickly to the FDA is essential to prevent delays in manufacturing or distribution.

With over 300 life science implementations, OpenText has long provided validated ECM solutions for pharmaceutical records and process management, and through its tight integration with SAP, ensure compliance with current and emerging FDA and EMA regulations.

In the next Regulatory Matters, I’ll go into more detail about the Drug Supply Chain Security Act, which outlines critical steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States, also known as “Track and Trace.”

Jaleel Shujath

Jaleel is an Industry Strategist in Life Sciences for OpenText, based near Washington DC.

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