Recommendations from EMA to strengthen supply chains of critical medicines published

On 23rd of April 2024 the EMA (European Medicines Agency) has published a list of recommendations to strengthen supply chains of products listed in the Union list of critical medicines.

These measures have been created by EMA´s Medicinal Shortages Steering Group (MSSG) and aim to ensure the availability and secure the supply of critical medicines whose supply chain has been identified as vulnerable. The MSSG was founded under the Regulation (EU) 2022/123 with the aim of providing a strong response to public health emergencies and other significant events. 

Recommendations will be made based on a case-by-case evaluation while taking into consideration the weakness of the supply chain and the individual attributes of the medicine.

The possible measures are listed as follows:

• In order to ensure the supply of critical medicines the marketing authorization holders (MAHS) might be recommended to enlarge manufacturing capacity and to expand the number of suppliers in the supply chain.
• Furthermore, MAHs might be recommended to observe the availability of stock and forecast the demand and supply of medicines.
• Safety stocks of critical medicines should be created by specific actors in the supply chain (e.g. MAHs or the European Commission) as a safeguard against fluctuations in demand or supply.
• MSSG might demand that MAHs develop a so-called shortage prevention plan (SPP) for medicines listed in the Unions critical medicine list.
• Scientific and regulatory support from competent authorities to tackle the supply chain vulnerabilities which includes the support of small and medium sized companies.
• Improved cooperation among regulatory authorities which includes work-sharing mechanisms. This cooperation ensures flexibility in administrative and regulatory operations such as expedited timetables for necessary changes, which are necessary to eliminate vulnerabilities in the supply chain of critical medicines.
• Provision of incentives such as funding methods and other tools to enable the production of critical APIs, intermediates or medicinal products.

The MSSG will collaborate with the European Commission's Critical Medicines Alliance (CMA). While the MSSG provides short-to-medium term actions in form of regulatory and governmental policy guidance, the CMA concentrates on long-term measures with a focus on industrial policy.