U.S. FDA's Leadership in Developing APEC Supply Chain Security Toolkit for Medical Products

1. Global Approach to Protecting the Drug Supply Chain

Protecting the integrity of the medical product supply chain is complex and requires a global, multi-layered approach that includes prevention, detection and response strategies and actions. FDA collaborates with other regulators, industry members, academics and other stakeholders from economies around the globe to create and maintain APEC’s Supply Chain Security Toolkit for Medical Products. The toolkit contributes to global supply chain security for medical products by consolidating global resources in one place to deliver quality trainings and best practices. Source: https://www.fda.gov/drugs/drug-supply-chain-integrity/fda-leads-effort-create-supply-chain-security-toolkit-medical-products

2. The Toolkit

The toolkit covers the entire supply chain and lifecycle of medical products from raw materials to use by patients. It focuses on developing — and implementing through training programs — processes, procedures and tools to enhance global medical product quality and supply chain security. It contains recommended best practices and tools to prevent and detect substandard and falsified medical products before they reach consumers. It also provides tools to efficiently and effectively respond to incidents involving substandard and falsified medical products. Source: https://www.fda.gov/drugs/drug-supply-chain-integrity/fda-leads-effort-create-supply-chain-security-toolkit-medical-products

3. 10 Categories of Training Materials

The toolkit contains training materials intended to educate regulators, industry, health-care professionals and others on a particular part of the supply chain in 10 categories:

• Good manufacturing practices
• Good distribution practices
• Good import/export practices
• Clinical/retail pharmacy practices
• Product security
• Detection technology
• Internet sales
• Track and trace systems
• Surveillance and monitoring
• Single points of contact

Source: https://www.fda.gov/drugs/drug-supply-chain-integrity/fda-leads-effort-create-supply-chain-security-toolkit-medical-products

4. Ensuring Access to Authentic Products

The medical products industry is globalized and specialized. Countries must rely on the global marketplace to provide the medical products needed to keep consumers healthy and ensure uninterrupted access to authentic and safe products. To address this issue, regulators, industry, non-governmental organizations, international organizations and academics from around the globe created APEC’s roadmap to promote global medical product quality and supply chain security. Source: https://www.fda.gov/drugs/drug-supply-chain-integrity/fda-leads-effort-create-supply-chain-security-toolkit-medical-products

5. FDA Led the Workgroup to Create the Toolkit

This roadmap developed into APEC’s Global Supply Chain Integrity Priority Workgroup Area (PWA), championed by FDA, which created the toolkit in 2017. The PWA Steering Committee regularly updates the materials in the toolkit to ensure it remains a relevant and valuable resource. Source: https://www.fda.gov/drugs/drug-supply-chain-integrity/fda-leads-effort-create-supply-chain-security-toolkit-medical-products

6. Using the Toolkit

The toolkit is used by industry and regulators from around the globe to adopt best practices and to strengthen laws and regulations to protect consumers from unsafe and substandard drug products. APEC Training Centers of Excellence for Regulatory Science are available to further train stakeholders, including industry and APEC and non-APEC economies, on how to use the toolkit. More information is included in the toolkit. The toolkit helps prevent counterfeit or substandard medical products by containing recommended best practices and tools to prevent and detect substandard and falsified medical products before they reach consumers, and by providing tools to efficiently and effectively respond to incidents involving such products. Source: https://www.fda.gov/drugs/drug-supply-chain-integrity/fda-leads-effort-create-supply-chain-security-toolkit-medical-products

7. Additional Resources

• View the Toolkit: https://www.usp.org/apec-supply-chain-security-toolkit
• APEC Supply Chain Security Toolkit for ways to share the toolkit and its content: https://socialpresskit.com/apec-scs-toolkit

Source: https://www.fda.gov/drugs/drug-supply-chain-integrity/fda-leads-effort-create-supply-chain-security-toolkit-medical-products