Medicines Shortages Steering Group

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On 11 March 2025, the European Commission published a proposal for a Critical Medicines Act (CMA).

The CMA introduces measures to improve the security of supply chains and availability of critical medicinal products and medicinal products of common interest in the European Union (EU). Some of the proposed measures directly affect Life Sciences companies, while other measures targeting the EU Member States can have a significant indirect impact on Life Sciences companies.Continue Reading European Commission Publishes Proposal for EU Critical Medicines Act

On 24 October 2023, the European Commission published a Communication on “Addressing medicine shortages in the EU” (the Communication). The Communication responds to the European Council’s call in June for urgent measures to ensure production and availability of critical medicines (i.e., the unavailability of which may cause patients serious harm, and whose supply must be ensured even in crisis periods) and to diversify international supply chains. On the same date, the European Medicines Agency (EMA) published details on the Solidarity Mechanism, recently created by the EMA Medicines Shortages Steering Group (MSSG) to facilitate redistribution of medicines between Member States (MS) in cases of critical shortages (i.e., medicine shortages where no alternative is available).

These EU-level actions are in addition to the mechanisms to tackle shortages already included in the European Commission’s proposal for a reform of the EU Pharmaceutical Legislation (read our advisory).Continue Reading New EU-level actions addressing shortages