International Recognition Procedure (IRP)
A must-watch for anyone involved in regulatory affairs or lifecycle management.
Navigating the EU HTA Regulation
Asphalion helps you successfully prepare for the European Union Health Technology Assessment Regulation (HTAR), which enters into application on January 12, 2025. This regulation introduces mandatory Joint Clinical Assessments (JCA) for oncology products and advanced therapy medicinal products (ATMPs), with phased implementation for orphan drugs and high-risk medical devices by 2030.
A new regulatory framework for coordinated clinical assessments
This regulation aims to:
Implementation roadmap of the EU HTA Regulation (Regulation 2021/228), detailing the timeline for Joint Clinical Assessments (JCA) of oncology products, ATMPs, orphan medicines, and high-risk medical devices.
End-to-end support across the HTA lifecycle
From early development to post-authorisation, Asphalion provides strategic and technical support across every stage of the HTA and regulatory process, including scientific advice, JCA dossier preparation and local adaptation.
Health Technology Assessment Regutaltion (HTA) Solutions
At Asphalion, we provide comprehensive support to help you navigate the complexities of the new EU HTA regulation and ensure successful market access across Europe:
We work closely with clients from early development phases to design robust, HTA-compliant strategies:
Our team ensures efficient and compliant JCA dossier development:
We help clients optimise their strategy by leveraging parallel EMA-HTA advice:
We equip your teams with practical knowledge to operate under HTAR:
Beyond the JCA, we support adaptation to national contexts:
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Why Asphalion?
With over 25 years of experience in regulatory science, Asphalion combines scientific expertise and strategic insight to help you succeed under the new EU HTA framework:
Main benefits
Whether you are preparing your first JCA submission or scaling market access across the EU, our team helps you do it faster, safer, and with full regulatory confidence.
The EU HTA regulation is transforming how clinical evidence is assessed in Europe. At Asphalion, we help you anticipate change, build compliant strategies, and reach your markets faster.
Contact us to learn more or schedule a consultation with our experts.
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