13/14 March 2024
The European Medicines Agency EMA has published a guidance for industry on "Good practices to ensure continuity in the supply of human medicines, prevent shortages and reduce their impact".
The document provides recommendations to marketing authorization holders, wholesalers, distributors, and manufacturers on preventing shortages of human medicines and managing shortage events. It emphasizes the importance of proactive measures to reduce the likelihood of shortages and outlines common reasons for shortages. The document serves as guidance and does not provide conclusive interpretations of legal obligations. It was developed within the HMA/EMA Task Force on the Availability of Authorised Medicines for Human and Veterinary Use, with a focus on actions to be taken by key stakeholders in the supply chain. The roles and responsibilities of various stakeholders, including marketing authorization holders, manufacturers, wholesale distributors, national competent authorities, EMA, national health service providers, healthcare professionals, and patient representative groups, are discussed. The document highlights the need for effective oversight, strategic planning, quality culture, early detection of potential shortages, regulatory coordination, communication, and collaboration among stakeholders to prevent and mitigate shortages.
The recommendations include:
The recommendations are based on the analysis of causes of shortages and regulators' first-hand experience in coordinating the management of shortages, and industry associations have been consulted.
The document defines shortages as situations where the supply of a medicinal product does not meet the demand at a national level. The reasons behind shortages can vary and can be linked to different steps in the supply chain. The document emphasizes the importance of proactive measures to address the underlying causes of shortages, such as quality and manufacturing issues, unexpected increased demand, regulatory issues, and distribution issues. These preventative strategies should be integrated into the lifecycle management of medicines. It is noted that shortages and their causes are often interconnected, requiring multiple preventative strategies to address them effectively. The European Commission's Pharmaceutical Strategy is mentioned as a complementary approach to address medicine shortages. International collaboration and alignment are seen as crucial for ensuring the security of medicine supplies and preventing shortages. The document encourages the pre-emptive use of available information and intelligence to optimize the implementation of preventative strategies. By implementing these strategies, both patients and health systems can benefit from continued supply or preparedness to mitigate the impact of shortages.