EMA Takes A Dive Into Patient-Level Data

The European Medicines Agency will begin a pilot in 2021 to examine the practical aspects of undertaking patient-level data assessments during medicines evaluation and identify scenarios when such assessments might be useful.

Index
EMA Had Requested Patient-Level Data While Reviewing Yescarta • Source: Shutterstock

The exponential growth of big data and the need for new analytic techniques to go with it have made it important for the European Medicines Agency to have a clear stand on whether individual patient-level data (PLD) should be routinely assessed as part of the EU marketing authorization procedure.

To address the issue, the EMA is gearing up to undertake a broad review of the experience gained so far by its various scientific committees in reviewing PLD, Peter Arlett...

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 Europe

EMA Touts Faster Global Post-Approval Changes Via Regulatory Reliance

 

The European Medicines Agency says that a regulatory reliance pilot that it is supporting to speed up assessments of post-approval changes appears to be accelerating evaluation timelines in non-EU countries.

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.

New EU Approvals

 

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include two new products, one of which is Vyjuvek, Krystal Biotech's advanced therapy for treating dystrophic epidermolysis bullosa.

EU CHMP Opinions And MAA Updates

 

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

More from Geography

US FDA Meeting Drought Ends … With A Vengeance

 

The first 100 days of the Trump Administration were notable for an extraordinary decline in the number of public meetings hosted by the US Food and Drug Administration. But the schedule changed quickly.

PBM Investigation, Enforcement Action ‘Critical Priorities’ At FTC, Chair Says

 
• By 

The new FTC chair addressed concerns that staffing cuts will undermine the commission’s commitment to pharmacy benefit manager oversight.

EU CHMP Opinions And MAA Updates

 

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.