Committed to providing timely and cutting-edge content, we curate essential updates from the forefront of medical advancements. Today, we highlight two crucial publications released by the European Medicines Agency, shedding light on key developments and regulatory insights in the field.

The European Commission, the Heads of Medicines Agencies (HMA) and the EMA have issued recommendations for actions to avoid shortages of key antibiotics used to treat respiratory infections for European patients in the next winter season. These recommendations, which have been developed through the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG), complement the process to develop an EU list of critical medicines. In close cooperation with the EU Member States, the Commission will take operational follow-up actions, including, if necessary, possible joint procurements.

This Guide was developed in collaboration between EMA and the ENCePP Research Standards and Guidance Working Group and has been published on the ENCePP website. Its has been revisited to better illustrate the evidence generation flow and to increase the emphasis on important methodology. Besides the update of several chapters, some have been revised to reflect a fast-changing environment: Chapter 9 on Research networks for multi-database studies addresses the expansion and use of DARWIN EU®, and Chapters 16.1 on Comparative effectiveness research, 16.5 on Artificial intelligence, and 16.6 on Real-world evidence (RWE) and pharmacoepidemiology have been extensively revised.

New recommendations, to foster transparency and high quality of non-interventional studies, and to facilitate their assessment, include the use of the causal inference target trial emulation approach and the estimand framework, and the use of the HARPER protocol template.

The Foreword from the co-chairs of the ENCePP Steering Group highlights the continued involvement of ENCePP in sound pharmaco-epidemiological research, including drawing lessons from the COVID-19 pandemic and addressing new methodological challenges.

Read the full publications below:

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