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‘We Need Help,’ Says EMA Chief Amid COVID-19 & Burgeoning Workload

 
• By Ian Schofield

COVID-19, resource constraints and a forthcoming expansion of its responsibilities are piling the pressure on the EU regulator.  

Credit squeeze concept - piggy bank in clamp
The EMA's financial and staff resources are under pressure • Source: Alamy

The executive director of the European Medicines Agency has made a plea for more staff and financial resources to help the agency face the challenges posed not only by COVID-19 but also by other work such as dealing with access to document requests and publishing clinical trial data – not to mention the proposed expansion of the organization's mandate as part of EU plans for a “European Health Union.”

“We need help. We definitely need help,” Emer Cooke told a 30 November hearing of the European Parliament’s environment and...

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World’s First Hemato-Oncology Microbiota Therapeutic Among Latest New EU Filings

 
• By Neena Brizmohun

The European Medicines Agency has started reviewing for potential EU marketing approval six new products, including MaaT Pharma’s microbiota therapeutic for acute-graft-versus-host disease, and AstraZeneca's camizestrant for locally advanced or metastatic breast cancer.

Sponsors Asked, EMA Delivered: One Handbook To Navigate CTIS

 
• By Vibha Sharma

The European Medicines Agency has revised the sponsor handbook for the Clinical Trials Information System, bringing together guidance that was previously scattered across multiple platforms and documents to help sponsors navigate the trial process more efficiently.

Room For Improvement? EU Industry Prepares Feedback For SPC Manufacturing Waiver Review

 
• By Dave Wallace

As the European Commission prepares a formal evaluation of the SPC manufacturing waiver, the generics and biosimilars industry is getting ready to provide detailed feedback on what works – and what doesn’t. At Medicines for Europe’s legal affairs conference, delegates heard the latest updates.

Report Shows Extent Of AI Use In EU Medicines Regulation During 2024

 
• By Eliza Slawther

The AI observatory, created by the European medicines regulatory network to track the evolving use of artificial intelligence in medicines development and regulation, has issued its first annual report.

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