EMA: Guidance for Industry to Prevent Medicine Shortages

On 17 May 2023, EMA published recommendations for industry on the good practices to ensure continuity in the supply of human medicines, prevent shortages and reduce their impact. The 14-page guidance describes the various stakeholders involved in the medicine supply chain and their responsibilities and roles in the prevention and management of medicine shortages. It provides ten recommendations for marketing authorisation holders, wholesalers, distributors, and manufacturers to minimise the occurrence of medicine shortages and their impact.

The recommendations include:

• informing national competent authorities of potential or actual shortages as early as possible and providing detailed information to better predict the possible impact and implement preventive measures
• establishing robust shortage prevention and shortage management plans
• optimising pharmaceutical quality systems and increasing the resilience of complex, multinational supply chains
• timely communication between the various stakeholders in the medicine supply chain
• general principles to promote fair and equitable distribution of medicines to meet the needs of patients.

They are based on the analysis of the causes of shortages and regulators’ first-hand experience in coordinating the management of shortages, and industry associations have been consulted. The guidance has been developed by the HMA / EMA Task Force on the Availability of Authorised Medicines for Human and Veterinary Use. It complements the guidance for patients and healthcare professional organisations published last year. As medicine shortages can meanwhile be considered a global health problem, ensuring the availability of authorised medicines in the European Union (EU) is a key priority for EMA and the European medicines regulatory network.

Source:

EMA/HMA: Good practices to ensure continuity in the supply of human medicines, prevent shortages and reduce their impact