Drug shortages and supply disruptions are increasingly emerging as a global challenge. As part of the European Medicines Agency's (EMA) initiative on drug shortages, PDA participated in a collaborative inter-association drug shortage team to develop solutions to address prevention and communication of drug shortages caused by manufacturing and quality related disruptions.

As a contributor to this inter-association drug shortage initiative, PDA has developed TR 68: Risk-Based Approach for Prevention and Management of Drug Shortages. This Technical Report is expected to be globally significant as it is the first practical approach to identifying and mitigating drug shortage risks in a structured way, and thus once implemented it could lead to fewer drug shortages. It has been developed with input and support from EMA, several EU National Competent Authorities (NCAs) and FDA. EMA and European inspectors will be promoting the TR in the European Union as best practice for proactively identifying and managing risks to supply caused by manufacturing and quality issues.

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Table of Contents:

1. Introduction
2. Glossary of Terms
3. Recognizing Drug Shortages as a Global Problem
4. Management Responsibilities
5. Risk-Based Approaches for Prevention of Drug Shortages
6. Risk Triage Model
7. Drug Shortage Prevention and Response Plan
8. Reacting to Drug Shortages caused by Manufacturing and Quality Issues
9. Conclusions
10. References
11. Appendix A
12. Appendix B

Figures and Tables Index