EMA Homes In On How To Improve RWD Quality

Draft guidance from the European Medicines Agency explores how data quality can impact the use of real-world data to generate real-world evidence for regulatory assessments.

Female engineer concept. GUI (Graphical User Interface).
New draft guidance explains how to assess and improve the quality of real-world data (Shutterstock)
Key Takeaways
  • Draft EU guidance on how to assess and improve the quality of real-world data (RWD) that is used for regulatory purposes is out for consultation until 31 January 2025.


The European Medicines Agency is seeking feedback on draft guidance that aims to provide “actionable and focused recommendations” for assessing...

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

More from Real-World Evidence

AI Will Bolster, Not Squelch, Patient Voice In Clinical Research, US FDA Says

 
• By 

Artificial intelligence tools used for clinical research should be developed with input from patients and focus on their needs and abilities, FDA experts said.

Post-Approval, Real-Time Monitoring Will Help Approval Standards, US FDA’s Makary Says

 
• By 

The FDA will use electronic health records to “get eyes” on drugs immediately after approval, Commissioner Martin Makary told the DIA 2025 Global Annual Meeting. He also wants to reduce development time with better communication and new approval pathways.

US FDA’s Prasad: ‘We Will Always Embrace Surrogate Endpoints’

 

The new CBER director, once best known in the pharma world for criticizing accelerated approval, committed to expediting cancer drugs with surrogate endpoints.

UK And US Regulators In Sync On RWD External Control Arms

 
• By 

The UK regulator’s draft guideline on the use of external control arms based on real-world data reflects concepts similar to those outlined by the US Food and Drug Administration.

More from Pink Sheet

Engage With HTA Body NICE Before Submitting MAA, UK Govt Tells Companies

 

The government has explained how to navigate the UK’s regulatory and market access funding mechanisms.

EU Pharma Reform: Council Wants Strengthened Member State Powers On Drug Supply

 

The Council of the EU’s vision for the pharma reform package includes a stronger role for member states regarding the supply of medicines and the prevention of indication-stacking for orphan drugs.

Quotable: Top Experts On Policy Hot Topics

 

The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.