EU HTA Regulation: Industry’s Missed Opportunity & The PICO Process

Pharmaceutical companies missed a big opportunity to help shape the scoping process for the forthcoming EU-level joint clinical assessments, but they can still contribute to how the process develops, according to Niklas Hedberg, formerly chair of the recently concluded European Network for Health Technology Assessments.

Close-up of European Names on Maps
Industry can still contribute to developing the scoping system for the EU-level joint clinical assessments • Source: Shutterstock

Companies concerned about European countries using PICO (population, intervention, comparator, outcomes) surveys to help frame the parameters of the EU-level joint clinical assessments (JCA) that will be conducted under the Health Technology Assessment (HTA) Regulation should rest assured.

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 To Consider Approvals For Eight Orphans, Including Vertex’s CF Drug Alyftrek

 

The European Medicines Agency is this week expected issue opinions on whether the European Commission should grant EU marketing authorization for 19 new products.

Making EU Clinical Trials Regulation A Success ‘Takes All Of Us To Tango’

 

Sponsors and regulatory agencies within the 27 EU member states must all be “committed” to working with the EU Clinical Trials Regulation in the most appropriate way to keep pace with other countries, including the UK where competition is heating up, says Miguel Forte, CEO of Kiji Therapeutics.

EU Biosimilar Filings, Opinions And Approvals

 

A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.

Industry Highlights Issues With EU HTA Regulation’s PICO Framework For Vaccines

 

Vaccine developers should be aware that the framework underpinning the new EU Health Technology Assessment (HTA) Regulation might not be suitable for immunizations, but actions from policymakers and industry could help mitigate some issues, a senior figure from GSK says.

More from Geography

US FDA Shows Support For Generic Drug User Fee Goals Amid Cutbacks

 

The FDA struck an upbeat tone during its annual Generic Drugs Forum despite an unprecedented period of cutbacks and disruptions and reiterated a desire to continue meeting user fee goals.

Making EU Clinical Trials Regulation A Success ‘Takes All Of Us To Tango’

 

Sponsors and regulatory agencies within the 27 EU member states must all be “committed” to working with the EU Clinical Trials Regulation in the most appropriate way to keep pace with other countries, including the UK where competition is heating up, says Miguel Forte, CEO of Kiji Therapeutics.

ICH Modernizes Stability Testing Guideline

 
• By 

The International Council for Harmonisation has consolidated and modernized its existing stability guidelines into one document, and addressed modern stability testing approaches like modeling, bracketing, and matrixing.