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Drug Shortage

Drug shortages demand attention and collaboration from regulators, industry, distributors and patient groups. This revision aligns the text of TR-68 from 2014 with the current regulatory environment and terminologies used for drug shortages.

PDA’s Contributions

Technical Report No. TR 68 (Revised 2024): Risk-Based Approach for Prevention and Management of Drug Shortages

TR-68 was originally developed as part of the inter-association collaborative response to the European Medicines Agency’s (EMA) initiative on medicinal product shortages caused by manufacturing, quality, and/or good manufacturing practice (GMP) issues. The risk-based approach and concepts in the original technical report are broadly recognized and remain unchanged.

For 78 years, PDA has supported our members and the pharmaceutical industry in their work to provide patients with the medicines they need. Unfortunately, drug shortages have become more frequent, more severe, and longer-lasting globally, and the causes are, in most cases, multifactorial. Based on the impact this issue has to the pharmaceutical companies and the patients they supply. PDA has made the impactful decision to provide the recently released Technical Report No. 68 free of charge globally.

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Drug Shortage
Triage Model

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Drug Shortage Risk Register - Appendix 1

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Prevention and Response Plan - Appendix 2

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On Demand
Additional Resources
Drug Shortage Prevention Infographic
The infographic includes all the operations and the quality controls that are required to procure and distribute an API.
PDA participates in an inter-association task force to deliver to the European Medicines Agency (EMA) a proposal and plan that addresses the prevention of drug shortages due to manufacturing quality issues and a complementary project on communications. For more details on the complementary contributions of the other associations please see the following: Final report of the inter-association team: Prevention of Drug Shortages Based on Quality and Manufacturing Issues, December 2014
European Medicines

The EMA templates for shortage prevention and mitigation plans were published June 2024.

Shortage Mitigation Plan (SMP)
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Shortage Prevention Plan (SPP)
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Scheduled Conferences and Training Opportunities
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Drug Shortage Infographic

The infographic includes all the operations and the quality controls that are required to procure and distribute an API.

Read More
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