Guidance for Industry to Prevent and Mitigate Drug Shortages


EMA has issued the following recommendations for the industry:


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Good Practices to Ensure Continuity of Supply, Prevent Shortages and Mitigate Impacts of Human Medicines

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Medicine shortages are a global health problem with an increasing impact on European countries. Shortages can lead to drug distributions and delays in critical treatments, which can have a significant impact on patient care. In addition, patients must use less effective alternatives, potentially increasing the risk of medication errors. Ensuring the availability of approved medicines in the European Union (EU) is a key priority for the EMA and the European Medicines Regulatory Network.

This guidance describes the various stakeholders involved in the pharmaceutical supply chain and their responsibilities and roles in preventing and managing pharmaceutical shortages. We offer 10 recommendations for marketing authorization holders, wholesalers, distributors and manufacturers to minimize the occurrence and impact of drug shortages. Recommendations include:

  • Notify national authorities of potential or actual shortages as early as possible to better anticipate possible impacts and provide detailed information to implement preventive measures.
  • Establish strong shortage prevention and shortage management plans.
  • Optimize pharmaceutical quality systems and strengthen the resilience of complex multinational supply chains.
  • Timely communication between various stakeholders in the pharmaceutical supply chain.
  • General principles to promote the fair and equitable distribution of medicines that meet patient needs.

The recommendations are based on an analysis of the causes of shortages and the direct experience of regulators coordinating the management of shortages, as well as consultation with industry associations.

This guidance has been developed by the HMA/EMA Task Force on Availability of Licensed Medicines for Human and Animal Use. This task force is a joint working group set up by the EMA and the Commissioner for Medicines Agency (HMA) to focus on the availability of licensed medicines. Presented at a multi-stakeholder workshop on shortages held on March 1 and 2, 2023.

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Guidance for patient and health professional associations

It was issued last year to help prevent and manage shortages of human medicines.



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