Navigating market access pathways across European Union markets in 2025 and beyond

What do the joint clinical assessments (JCA) in Europe mean for your pharma or medtech company?

The parallel paths of the joint clinical assessment process and the marketing authorization process of the European Medicines Agency (EMA) place manufacturers in unsure territory.

The new regulation seeks to improve the availability of innovative health technologies across the EU.

Key considerations in creating a meaningful JCA strategy:

The JCA process will be in effect January 2025 for oncology products, advance therapy medicinal products, and medical devices. It expands to orphan products in 2028 followed by all products in 2030.
Manufacturers will have a 90-day window for dossier preparation and submission from the time of release of the PICO information.
The importance of including payer-relevant endpoints and comparators in the registration-enabling clinical trials is essential to advancing in European markets.

The new regulation seeks to improve the availability of innovative health technologies across the EU.
Clinical efficacy and safety evidence submitted in the EMA regulatory dossier is mirrored in the JCA.
Endorsement of the final JCA report is needed within 30 days of the European Commission to approve the medication or device.

Start planning for the JCA now.

RTI Health Solutions helps pharma and medtech companies prepare for JCA throughout the product lifecycle with a suite of strategic and technical services.

Contact our team using the form below. We can help with early engagement, PICO definition, evidence strategy, impact assessment, and other workstreams.

Navigating market access pathways across European Union markets in 2025 and beyond

What do the joint clinical assessments (JCA) in Europe mean for your pharma or medtech company?

Key considerations in creating a meaningful JCA strategy:

Start planning for the JCA now.

Contact us