EU HTA

Your go-to resource for better market access

Navigating the EU HTA Regulation

Ensure readiness for Joint Clinical Assessment (JCA) and Joint Scientific Consultation (JSC)

The EU Health Technology Assessment Regulation (HTAR) is transforming market access for pharmaceutical companies, providing a unified pathway to streamline approvals and accelerate patient access across Europe. This hub brings you everything you need to stay ahead - expert insights, strategies, and the latest updates - so you can navigate the evolving regulatory landscape with confidence and achieve better market access across EU member states.

Our EU HTA project offerings

Organizational excellence

Product strategy

Organizational excellence

EU HTA company implementation plan & execution

Assess organizational status quo and identify recommended key actions and support in execution to ensure company readiness

Organizational excellence

EU HTA company implementation plan & execution

Assess organizational status quo and identify recommended key actions and support in execution to ensure company readiness

Organizational excellence

EU HTA playbook & process integration

Determine all the steps required, key roles and responsibilities to develop a successful EU HTA strategy and integration in current processes

Organizational excellence

EU HTA playbook & process integration

Determine all the steps required, key roles and responsibilities to develop a successful EU HTA strategy and integration in current processes

Organizational excellence

EU HTA knowledge repository, management & training

Monitor EU landscape and create up to date repository, develop an EU HTA training curriculum and build an ecosystem for delivery and knowledge maintenance

Organizational excellence

EU HTA knowledge repository, management & training

Monitor EU landscape and create up to date repository, develop an EU HTA training curriculum and build an ecosystem for delivery and knowledge maintenance

Product strategy

PICO simulation

Predict potential PICOs for products and prioritize them for evidence evaluations

Product strategy

PICO simulation

Predict potential PICOs for products and prioritize them for evidence evaluations

Product strategy

Scientific advice (including JSC)

Identify the most appropriate scientific pathway (including JSC) and support preparation activities

Product strategy

Scientific advice (including JSC)

Identify the most appropriate scientific pathway (including JSC) and support preparation activities

Product strategy

EU JCA evidence generation

Assess evidence development plan in its ability to meet EU JCA requirements (based on preliminary PICO simulation) and develop recommendations for enhancement

Product strategy

EU JCA evidence generation

Assess evidence development plan in its ability to meet EU JCA requirements (based on preliminary PICO simulation) and develop recommendations for enhancement

Product strategy

EU JCA submission

Develop EU JCA narrative to guide the dossier development

Product strategy

EU JCA submission

Develop EU JCA narrative to guide the dossier development

Product strategy

EU JCA external stakeholder mapping & engagement strategy

Identify EU and local stakeholders that may inform the PICO survey and develop an engagement plan

Product strategy

EU JCA external stakeholder mapping & engagement strategy

Identify EU and local stakeholders that may inform the PICO survey and develop an engagement plan

Product strategy

EU HTA local implementation

Align cross-functional, global, and local processes and timelines for execution of the EU JCA strategy

Product strategy

EU HTA local implementation

Align cross-functional, global, and local processes and timelines for execution of the EU JCA strategy

Find us at

ACCESS EU 2026

Find us at ACCESS EU 2026 from 7 - 9 October in Lisbon, Portugal.

 

Join our expert at Plenary 3 – One Assessment, Many Futures: The Evolution of EU JCA on 9 October from 8:30–10:00 AM

 

The panel will explore the future of EU Joint Clinical Assessments, including alignment with local P&MA processes, evolving payer expectations, patient involvement in PICO scoping, and the expansion of the JCA framework to additional product categories.

 

Contact us to schedule a meeting and discuss the evolving EU HTA landscape.

ISPOR Europe 2026

This year, ISPOR Europe will convene from 8 - 11 November in Vienna, Austria.

 

Meet our experts at booth 501 to discuss the latest developments in global pricing and market access. From navigating the EU JCA to leveraging real-world evidence and optimizing pricing strategies, our team looks forward to exchanging insights and perspectives to drive market access in pharma.

 

Contact us to schedule a meeting and discuss the evolving EU HTA landscape.

Our webinars

Key events

  • October - November 2026

  • June 2026

  • May 2026

  • February 2026

  • November 2025

  • February 2025

  • January 2025

  • December 2024

  • November 2024

  • October 2024

  • May 2024

  • January 2022

October - November 2026

 

2027 HTACG Work Program prepared / adopted

HTACG adopts the 2027 Annual Work Program, outlining the strategic direction for EU-level HTA activities and the planned volume of JCAs and JSCs for the coming year.

June 2026

 

First EU JCA Report Published

HTACG endorses and publishes the first JCA report and summary report under the EU HTA Regulation, concerning Ojemda/tovorafenib for the treatment of pediatric low-grade glioma.

May 2026

 

Guiding Principles on Data Transparency Adopted

HTACG adopts and publishes guiding principles on data transparency, setting out expectations for the handling and publication of data in joint work under the EU HTA Regulation.

Click here for source

Updated Methodological and Procedural Guidance Published

HTACG publishes updated Q&A on methodological and procedural aspects of JCAs, alongside new guidance on data transparency and an FAQ document on the publication of JCA reports.

Click here for source

 

February 2026

 

HTACG 2025 Annual Report published

HTACG publishes its first annual report on the implementation of the EU HTA Regulation summarizing progress during 2025, including the launch of 13 JCAs and preparatory activities for medical device and IVD JCAs planned to start in 2026.

Click here for source

November 2025

 

HTACG Adoption of the Annual Work Program for 2026

Adoption of the 2026 Annual Work Program, outlining the strategic direction for the HTACG over 2026, and the planned number of JCAs and JSCs. 

Click here for source

February 2025

 

PICO Exercise Outputs Published

HTACG publishes the outputs of PICO exercises conducted to test and refine the scoping process for medicinal-product JCAs, supporting the development and practical application of the guidance on PICO methodology.

Click here for source

January 2025

 

Launch of JCA for Cancer Medicines and ATMPs

The EU JCA process starts for new cancer medicines and advanced therapy medicinal products (ATMPs).

December 2024

 

Implementing Act on JSC

The EU JCA Implementing Act on Joint Scientific Consultations on Medicinal Products for Human Use is adopted. This act outlines the timelines and key procedural steps for manufacturers seeking guidance to support regulatory and HTA decision-making.

Click here for source

November 2024

 

HTACG Adoption of the Annual Work Program for 2025

Adoption of the 2025 Annual Work Program, outlining the strategic direction for the HTACG over 2025, and the planned number of JCAs and JSCs.

Click here for source

Guidance on filling in the JCA dossier template (medicinal products)

Guidance on filling in the joint clinical assessment dossier template is adopted, as a methodological supporting document to EU JCA Implementing Acts. 

Click here for source

Guidance on steps and timeframe for JCA (medicinal products)

Guidance on procedural steps and timeframe for joint clinical assessments is adopted as a methodological supporting document to EU JCA Implementing Acts.

Click here for source

Guidance on the scoping process

Guidance on methodology for PICOs is adopted, providing detailed methodological guidelines and recommendations for the PICO scoping process.

Click here for source

October 2024

 

Implementing Act on Exchange of Information with EMA

The EU JCA Implementing Act on Exchange of Information with the European Medicines Agency is adopted, establishing procedural rules for seamless cooperation in information exchange between HTACG, EMA, and experts supporting joint clinical assessments. 

Click here for source

Implementing Act on CoI Rules

The EU JCA Implementing Act on Conflict-of-Interest Rules is adopted, outlining rules for managing conflicts of interest among stakeholders involved in joint clinical assessments, ensuring assessments are conducted in an independent, impartial, and transparent manner. 

Click here for source

May 2024

 

Implementing Act on JCA

The EU JCA Implementing Act on Joint Clinical Assessment of Medicinal Products for Human Use is adopted, outlining the timelines and key procedural steps for the joint clinical assessment of medicinal products.

Click here for source

January 2022

 

EU HTA Regulation Adopted

The EU HTA Regulation is adopted, establishing a new framework for Joint Clinical Assessments of new medicinal products across EU Member States and outlining a phased implementation plan for its adoption.

Click here for source

How we've helped

Contact our experts

  • EU HTA & Health Policy team
  • Advisory team
Partner
Paris, France
Partner
New York, USA
Senior Director
Milan, Italy
Senior Partner
Munich, Germany
Senior Partner
Cologne, Germany
Senior Partner
New York, USA
Partner
Cologne, Germany

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