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

EU HTA Regulation: Views Wanted On Draft Rules On Joint Scientific Consultations

 
• By Francesca Bruce

A newly published draft implementing act sets out the procedural rules for the joint scientific consultations that are foreseen by the EU’s Health Technology Assessment Regulation.

ADVICE
Joint Scientific Consultations will help companies prepare for forthcoming EU-level joint clinical assessments • Source: Shutterstock

Health technology developers will for the next four weeks have a chance to influence the rules governing the joint scientific consultations (JSCs) that will help them prepare for EU-level joint clinical assessments, which go live from January.

HTA Regulation And Joint Scientific Consultations

The 2022 Health Technology Assessment Regulation aims to increase cooperation on HTA across Europe and lays the foundations for EU-level joint clinical assessments. These assessments will be similar to relative effectiveness assessments performed at member state level.

Joint scientific consultations (JSCs), which are also foreseen under the HTA Regulation, allow companies to seek scientific advice from the Member State Coordination Group on HTA during early clinical development.

Industry has expressed concern that the number of JSC slots is inadequate, and that there is a lack of opportunity for companies participate in the JCA scoping process. (Also see "Lack Of Industry Involvement In EU HTA Scoping Process Exacerbates ‘Unworkable’ Timelines" - Pink Sheet, 19 April, 2024.) 

On 1 October, the European Commission published for consultation its draft implementing act on procedural rules for the JSCs....

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

EU Pharma Overhaul May Reshape Aspects Of Drug Promotion And HCP Partnerships

 
• By Eliza Slawther

Lawyers explain how changes to rules around drug advertising and promotional activities under the EU pharma reform package could impact companies operating in the bloc, with one legal expert advising companies to “monitor developments closely.”

Industry Criticizes Dutch Decision To Slash PARP Inhibitor Reimbursement

 
• By Francesca Bruce

ZIN, the Dutch health technology assessment body, estimates that the number of patients eligible for treatment with a PARP inhibitor will be halved following a reassessment of drugs in the class.

EU Biosimilar Filings, Opinions And Approvals

 
• By Neena Brizmohun

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.

How Will Regulatory Filing Winds Blow Globally For Elevidys Following Patient Deaths?

 
• By Francesca Bruce

Roche’s filing for Elevidys in the EU followed applications in Middle Eastern countries because those markets accept applications based on approval by the US Food and Drugs Administration.

More from Middle East & Africa

Landmark Pilot Paves Way for Faster Drug Approvals In Africa

 
• By Anabel Costa-Ferreira

In a historic move for Africa, five products have been backed for approval via a pilot that tested a continental listing process.

Africa Partners With PIC/S To Elevate GMP Standards And Accelerate AMA’s Rollout

 
• By Neena Brizmohun

Efforts have stepped up to enhance Africa’s capacity to meet international good manufacturing practice standards, empower regulators across the continent, and drive sustainable growth in the pharmaceutical sector.

Japan Ships First Batch Of Mpox Vaccines To DRC

 
• By Lisa Takagi

Japan ships the first batch of 50,000 mpox vaccine doses to DRC after training local healthcare providers dealing with the persistent outbreak.