One year into EU JCA: Practical insights from the European Commission and Danish Medicines Council

After attending two recent reflections on the first year of EU Joint Clinical Assessments (JCAs): (1) an in-person session hosted by the Danish Medicines Council (DMC) on January, 12¹ and (2) the European Commission (EC) webinar for Health Technology Developers (HTDs) on January, 15², we can provide valuable early signals on how the EU HTA Regulation is functioning in practice and what sponsors should prioritize moving forward. 

Predicting PICOs based on clinical uptake, not regulatory status 

HTDs typically have 100 days (and in some cases only 60 days) to submit the JCA dossier after receiving final PICOs from the HTA Coordination Group (HTACG). Developing strategy and generating analyses within these timelines is only feasible if sponsors have already anticipated prospective PICOs – this exercise is commonly referred to as PICO prediction. 

A key takeaway for HTDs from the DMC was that the final HTACG PICO list will be grounded in routine clinical practice, not regulatory approval status alone. For sponsors undertaking PICO prediction, recent EMA-approved therapies could be deprioritized if real-world uptake remains limited, though uptake should be validated with local Key Opinion Leaders (KOLs). 

Shaping PICOs: where influence is – and isn’t – possible 

Both sessions clarified where influence is, and is not, possible in shaping PICOs.

The EC webinar addressed common misunderstandings around the Assessment Scope Explanation Meeting. Its purpose is to clarify the final PICO list and support dossier preparation; it is not a forum for methodological debate or PICO negotiation. As these meetings occur after scope finalisation (often post-CHMP LoQ), they should be treated as clarification checkpoints rather than influence opportunities.

The DMC noted there were opportunities for HTDs to inform the final PICOs published by the HTACG. Some countries (e.g., Finland) allow sponsor input, while others (e.g., Denmark) do not. Understanding where engagement is possible can materially improve PICO anticipation, and thereby the quality of the final submission.

Maximizing JSC impact for JCA success

Four Joint Scientific Consultations (JSCs) were conducted in 2025, each focusing on a single indication, similar to EMA Scientific Advice. A strong message from the EC was that JSC value is directly tied to the quality of the initial briefing package. Late additions (even if permitted up to 10 days prior) rarely shape discussions.

The DMC highlighted the growing role of Post-Launch Evidence Generation (PLEG) when aligned with JSC. Strategically designed PLEG can address subgroup uncertainties and evidence gaps not covered in pivotal trials, providing European-relevant data to support future JCA evaluations.

Signaling credibility and partnership from day one 

Early engagement with the HTA Secretariat, particularly through the Letter of Intent (LOI), is more than procedural. It signals how a sponsor will operate within a coordinated, capacity-constrained system. LOIs are expected around six months before EMA submission, yet 57% of 2025 LOIs were submitted late. In a system dependent on coordination and predictability, such delays are meaningful.

Looking ahead & final takeaways

After year one, several themes are already clear. The EU JCA system appears to reward:

1. Early strategic planning (e.g., effective use of JSC, anticipation of PICOs)
2. Procedural discipline (e.g., LOI timing, realistic planning)
3. Cross-functional alignment (EMA–HTA coordination)

Over the coming months an anonymized JSC annual report will be published (February 2026) alongside the first JCA report (May 2026). Both publications will serve as important reference points for emerging norms and expectations. We look forward to sharing our thoughts on these topics as the year progresses. 
Successfully navigating JCA requirements demands strategic planning, robust evidence generation, and stakeholder alignment. Parexel is supporting clients across the full JCA lifecycle, from early evidence planning through submission and beyond. Contact us to explore how we can support your future launches with a tailored approach to your JCA needs.  
 

Parexel provides this information as a service to clients and other friends for educational purposes only. It should not be construed or relied on as legal or regulatory advice. Readers should not act upon this information without seeking advice from professional advisers.

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References

1. Webinar (DMC): One Year of the EU HTA regulation, 12 January 2026
2. Webinar (European Commission): The EU HTA Regulation: Webinar for health technology developers of medicinal products, 15 January, 2026
    

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