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EMA seeks public opinion on AI in drug development
Public consultation is open for the European Medicines Agency (EMA)’s draft reflection paper on using artificial intelligence (AI) when developing and regulating medicines.
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Heads of Medicines Agencies (HMA)
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EMA prepares for winter antibiotic shortages
Anticipating similar demand of antibiotic use in prior winter seasons, the European Medicines Agency (EMA) has proposed key actions to mitigate supply chain issues.
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EMA guidance aims to prevent medicine shortages
The European Medicines Agency (EMA) has made recommendations for industry on how to prevent medicine shortages and reduce their impact.
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EU antibiotic shortages being monitored by MSSG
The Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) have stated it is closely monitoring and responding to the current EU antibiotic shortages.
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EMA approves biosimilar interchangeability in EU
Biosimilar medicines can now be interchanged with their reference medicine or an equivalent biosimilar, says European Medicines Agency (EMA).
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EU regulators release new workplan for accelerating clinical research
The latest workplan outlines how innovation in clinical research will be facilitated over the next four years, including modernising good clinical practice and issuing guidance on decentralised trials.
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Big Data Steering Group to enhance data quality and discoverability under new workplan
The Group plans to deliver a data quality framework by the end of 2022 and publish a public catalogue of European real-world data by 2025, among other actions.
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Pilot scheme to analyse raw trial data launched by EMA
The pilot will assess whether analysing raw clinical trial data is beneficial to regulatory decision making on marketing authorisation and post-authorisation applications.
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Drug repurposing pilot to support not-for-profit organisations and academia
The European Medicines Agency (EMA)'s pilot project will support not-for-profit organisations and academia in gathering evidence for the use of a drug in a new indication.
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EMA and HMA publish joint strategy on medicine regulation for next five years
The EMA and HMA have published their joint strategy for the next five years, detailing how the regulatory network can continue the supply of safe and effective medicines.
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Key principles for electronic product information implementation in EU released
The EC, EMA and HMA have published key principles on the various benefits of sharing medicinal product information electronically and how to implement this system.
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Combatting drug shortages in the EU: new guidance
New guidance for marketing authorisation holders has been released by the EMA to reduce the impact of drug shortages in the EU. Maurits Lugard and Anna-Shari Melin at Sidley Austin discuss the document and highlight its main points.
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EU releases guidance for medicine shortages
The EU has issued two guidance documents intended to advise the pharmaceutical industry and patients during medicinal shortages.
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Clinical trial sponsors called to publish results on EU database
All sponsors of clinical trials conducted in the European Union have been reminded of their obligation to make summaries of trial results.
