Risk-Based Approach for Prevention and Management of Drug Shortages Webinar (PDA 299)

Ensuring uninterrupted availability of and access to products, especially medically necessary, lifesaving, or life-sustaining critical medicines that do not have effective alternatives, is essential. Risk-Based Approach for Prevention and Management of Drug Shortages is a key concept regulators expect from marketing authorization holders and distributors to proactively prevent and manage product shortages caused by manufacturing, quality, and/or good manufacturing practice (GMP) issues. PDA has now updated Technical Report No. 68 Revised 2024 in this regard, which was originally developed in 2014. The approach to risk-based prevention of drug shortages presented in this revision of the TR remains unchanged.

This revision focuses on updating references and progress related to the current regulatory environment, for example, the International Council for Harmonisation (ICH) Quality Guideline Q9(R1): Quality Risk Management and terminologies that have since been published. Examples of preventive measures to reduce risks for drug shortages consider lessons learned. The use of simple templates and forms in this revision supports compliance with global expectations on managing and preventing drug shortages.

Sustainable access to safe, efficacious, and high-quality products every time a patient needs them is just as important as the therapeutic advances that have transformed the lives and survival of patients worldwide.