1. Pink Sheet
  2. >>Geography
  3. >>Europe

EMA Unveils Revamped Human Medicines Unit

Old Hands To Head Up New Task Forces

 
• By Ian Schofield

Europe’s top drugs regulator has reorganized its operations to tackle what it calls “fundamental changes” brought by new legislative initiatives, digital technologies, global trends in science, and staff losses due to Brexit. More changes are to be implemented during the course of 2020 in a bid to optimize the agency’s regulatory and scientific output.

Keyboard_Adapt
The EMA is taking steps to meet future challenges • Source: Shutterstock

The European Medicines Agency has implemented its new organizational structure, including a fully integrated human medicines division, a move that was first announced at the end of last year as part of a “future-proofing” exercise that the agency hopes will keep up the quality of its services to stakeholders.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Europe

More from Geography

Another Regeneron CRL Prompts Regulatory Operations Questions

 
• By Alaric DeArment

CEO Len Schleifer said during the company’s first quarter earnings call that most of the complete response letters the company has received related to third-party suppliers, not efficacy or safety.

UK Mandates Unmodified Standardized Contracts To Speed Clinical Trial Set-Up

 
• By Vibha Sharma

The policy expectation that the model clinical trial agreements are used without modification is in line requests from industry and the NHS/HSC.

Canada’s HTA Agency Reveals How To Submit AI-Driven Evidence

 
• By Neena Brizmohun

Recognizing that the evidence it receives in applications for health technology assessments will increasingly be informed by artificial intelligence, the CDA-AMC has clarified its expectations for companies that use AI methods in the generation and/or reporting of evidence.