EMA Creates Mechanism for Support during Drug Shortages
The agency’s solidarity mechanism allows Member States to support each other when there is a shortage of a critical medicines.
Text sign showing Industry News. Business photo text delivering news to the general public or a target public | Image Credit: © Artur - © Artur - stock.adobe.com
The European Medicines Agency (EMA) announced on Oct. 24, 2023 that its Medicines Shortages Steering Group (MSSG) has developed a voluntary solidarity mechanism that allows European Union Members States to support each other during drug shortages. The mechanism was based on a plan set up during the COVID-19 pandemic and can only be used under limited conditions. It is a last resort to be used after Member States have exhausted other possibilities.
EU Member States may request assistance in obtaining medicine stocks from other member states if they face a critical shortage that has been escalated to the MSSG for coordination at European level. The mechanism is part of other shortages actions the MSSG can carry out and is part of the MSSG Toolkit, which includes recommendations for monitoring drug supplies. The mechanism and toolkit are part of actions the European Commission is taking to protect the EU from drug shortages.
Source: EMA
A Novel, Enhanced, and Sustainable Approach to Audit Trail Review
July 4th 2025Eli Lilly and Company developed an innovative and sustainable approach to audit trail review (ATR) aimed at reducing the ATR burden while adhering to regulatory expectations and data integrity (DI) principles. The process has transformed employees' understanding of ATR and complemented the DI by design approach, leading to better system designs that meet expected controls and reduce non-value-added data reviews.
