Drug Shortage
The issue of drug shortages demands attention and collaboration from everyone involved; from regulators to developers, end users, and patients. This revision recognizes the advances made in pharmaceutical manufacturing and aligns the text of TR-68 with the current regulatory environment, for example, the International Council for Harmonisation (ICH) Quality Guideline Q9(R1): Quality Risk Management, ICH Quality Guideline Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management, regional regulations and guidelines, and terminologies used for drug shortages that have since been published. A risk triage approach for proactive management of drug shortage has been developed and will be trained.
PDA’s Contributions
Technical Report No. TR 68 (Revised 2024): Risk-Based Approach for Prevention and Management of Drug Shortages
PDA Technical Report No. 68: Risk-Based Approach for Prevention and Management of Drug Shortages was originally developed in 2014 as part of the interassociation 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. This revision updates the 2014 version to recognize emerging regulatory expectations and current terminology. The risk-based approach and concepts in the original technical report are broadly recognized and remain unchanged.
PDA Technical Reports are highly valued documents made available for free download to PDA Members or available for purchase at the PDA Bookstore.
Risk Management Tool
Conferences and training opportunities are being scheduled. For details see:
Additional Resources Relating to the Subject and Project
- Preventing and Managing Drug Shortages, PDA Letter Article, April 2014 (free for PDA members)
- Drug Shortage Info Graphic, PDA Letter, November/December 2014
- 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: