Joint Clinical Assessment (JCA) Update — What It Is and What’s Changing

The introduction of Joint Clinical Assessment JCA marks one of the most significant regulatory and market access changes in the European pharmaceutical landscape in decades. Established under the European Health Technology Assessment Regulation Regulation 2021 2282, JCA is reshaping how clinical evidence is assessed across EU member states.

For professionals working in regulatory affairs, market access, HEOR, clinical development, or medical affairs, understanding JCA is now essential. Below are six key things you need to know about this new EU level clinical evaluation framework and what it means for careers in pharma and biotech.

JCA Is a Centralised EU Clinical Assessment Process

Joint Clinical Assessment is designed to harmonise how clinical evidence on relative effectiveness and safety is evaluated across the European Union. It applies to new medicines and certain medical technologies seeking EU market entry.

Unlike the European Medicines Agency, which evaluates quality, safety and efficacy for marketing authorisation, JCA focuses specifically on comparative clinical outcomes. It assesses how a new therapy performs against relevant existing treatments in real world clinical practice.

Importantly, JCA does not include economic evaluation or cost effectiveness analysis. Pricing and reimbursement decisions remain the responsibility of individual member states.

The Mandatory Rollout Began in January 2025

The regulation officially came into force on 12 January 2025. The implementation is phased to allow industry and national authorities time to adapt.

The initial scope covers new oncology medicines and advanced therapy medicinal products seeking centralised EU marketing authorisation.

The expansion timeline is as follows:

• January 2028: Orphan medicinal products will be included
• January 2030: All new centrally authorised medicines will fall under JCA

This staged rollout means that companies must already be adapting development and submission strategies, particularly in oncology and advanced therapies.

JCA Runs in Parallel With the EMA Process

One of the most important strategic shifts is that JCA runs alongside the EMA centralised regulatory procedure. This parallel process creates both opportunity and complexity.

Clinical evidence generation must now satisfy two audiences simultaneously:

• Regulatory authorities assessing safety and efficacy
• HTA bodies evaluating comparative clinical value

This means that evidence planning needs to begin earlier than ever. In many cases, JCA considerations must be built into Phase 3 trial design before protocols are finalised. Comparator choice, endpoint selection, and subgroup analysis strategies now carry heightened importance.

For clinical development and regulatory professionals, this increases the need for early cross functional alignment.

The PICO Framework Sits at the Core of JCA

A defining feature of the JCA process is the scoping phase, where assessment questions are structured using the PICO framework:

• Population
• Intervention
• Comparator
• Outcomes

Multiple PICOs may be required to reflect different standards of care and clinical perspectives across EU member states. This can add complexity, particularly in therapeutic areas with varied treatment pathways.

Once the scope is agreed, the health technology developer must submit a comprehensive dossier within strict timelines, typically between 60 and 100 days, via an HTA secretariat platform.

An assessor and co assessor from different member states prepare a draft assessment, followed by a final report endorsed by the Health Technology Assessment Coordination Group.

This structured and collaborative model is intended to reduce duplication and improve consistency across Europe.

National HTA Bodies Must Consider the JCA Report

While JCA delivers a single EU level clinical assessment, national authorities still retain responsibility for reimbursement and access decisions.

However, they must give due consideration to the JCA report in their own evaluations. They may request additional information or conduct further local analyses, but the shared clinical assessment becomes the foundation for national appraisal.

For market access professionals, this creates a new dynamic. There is greater alignment at the clinical evidence stage, yet local engagement and value demonstration strategies remain critical.

Understanding both EU level coordination and national decision making will be a key skillset in the coming years.

JCA Is Driving New Career Opportunities in Pharma and Biotech

The introduction of JCA is not just a policy shift. It is also influencing hiring trends and capability requirements across the industry.

Key functions impacted include:

• Regulatory affairs
• Market access
• HEOR and real world evidence
• Clinical development
• Medical affairs
• Evidence strategy and early asset planning

There is increasing demand for professionals who can integrate regulatory and HTA requirements into unified evidence generation plans. Experience with PICO scoping, comparative trial design, indirect treatment comparisons, and cross country HTA coordination is becoming highly valuable.

Companies are also strengthening cross functional governance models to ensure alignment between global, regional, and affiliate teams.

In complex therapeutic areas such as oncology, cell and gene therapies, and rare diseases, strategic preparation for JCA will be essential to secure timely patient access across Europe.

What Is Still Evolving?

Although the framework is now live, methodological guidelines and operational processes continue to evolve. Early JCAs will provide practical learnings for both industry and member states.

Joint Scientific Consultations are expected to play an increasingly important role in helping companies align development plans with EU level expectations. As more products enter the process, refinements to templates, timelines, and coordination mechanisms are likely.

For professionals in pharma and biotech, staying informed and proactive will be critical. JCA is not simply another compliance requirement. It represents a structural transformation in how clinical value is assessed across Europe.

Those who understand its implications early will be best positioned to lead evidence strategy, optimise market entry, and drive successful EU launches in the new HTA era.

https://health.ec.europa.eu/health-technology-assessment/implementation-regulation-health-technology-assessment/joint-clinical-assessments_en