FDA to Lead International Effort to Secure the Supply Chain

On July 20, 2017, in an FDAVoice blog post, Ilisa Bernstein, Deputy Director of FDA’s Office of Compliance in FDA’s Center for Drug Evaluation and Research, announced that the agency would be leading an international effort to create a Supply Chain Security Toolkit for Medical Products. The toolkit will be a resource that covers the entire supply chain and lifecycle of medical products from raw materials to patient use. It will be used to develop and implement procedures, processes, and tools to enhance supply chain security.

Regulators from 21 nations, industry stakeholders, and representatives from non-government organizations and academia will be collaborating to develop strategies to secure the medical product supply chain across the world. The toolkit will use a multi-layer approach to prevent, detect, and respond to falsified medicines and products before they reach consumers. It will include materials on good manufacturing, distribution, import/export, and clinical practices; product safety; detection technology; Internet sales; track-and-trace systems; surveillance monitoring; and single points of contact.

“Substandard and falsified drugs are global problems that need global solutions and global collaboration. We cannot solve these challenges alone and we at FDA are continually looking for ways to collaborate and learn from our regulatory counterparts around the world,” Bernstein stated in the blog post.