Decoding the MSSG’s New Recommendations
The European Medicines Agency’s Medicines Shortages Steering Group (MSSG) has developed recommendations to ensure the availability and supply of critical human medicines with identified supply chain vulnerabilities. Key measures include:
- Recommendations to Marketing Authorisation Holders (MAHs):
- Increase manufacturing capacity.
- Diversify suppliers by adding alternative manufacturing sites.
- Monitor supply and demand forecasts and available stocks.
- Stockpiling:
- Encourage MAHs and the European Commission to stockpile medicines to buffer against supply or demand fluctuations.
- Shortage Prevention Plans:
- Request MAHs to establish plans for medicines on the Union list of critical medicines, with guidance and templates to be published in June 2024.
- Scientific and Regulatory Support:
- Provide assistance, especially to small and medium-sized enterprises, to address supply chain vulnerabilities.
- Work-Sharing and Accelerated Procedures:
- Use assessments by recognized authorities and fast-track necessary variations to manage supply chain issues.
The MSSG will collaborate with the European Commission’s Critical Medicines Alliance (CMA) to develop both regulatory and governmental policy recommendations for short- to medium-term actions. The CMA will focus on long-term industrial policy measures.
In case of critical shortages of medicines on the Union list, the MSSG’s toolkit will be employed to tackle the shortages.
About the MSSG: The MSSG was established under Regulation (EU) 2022/123 to enhance the Agency’s role in crisis preparedness and management of medicines and medical devices, ensuring a coordinated response to major events or public health emergencies.
Union List of Critical Medicines: This list identifies essential medicines whose supply continuity is crucial for EU healthcare systems, aiming to avoid shortages that could cause serious harm to patients. The European medicines regulatory network prioritizes actions to strengthen the supply chain and minimize the risk of disruptions for these critical medicines.