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.
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Drug Shortage Triage Model
DownloadDrug Shortage Risk Register - Appendix 1
DownloadPrevention and Response Plan - Appendix 2
DownloadAdditional Resources
- Drug Shortage Prevention Infographic
- 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
Scheduled Conferences and Training Opportunities
- Webinar on the TR-68 (coming soon in 2024)
- PDA's Global Event Calendar
- PDA Europe Event Calendar
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