Joint Clinical Assessment (JCA)

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A MANDATORY ASSESSMENT FOR NEW MEDICINAL PRODUCTS CENTRALLY APPROVED

The Joint Clinical Assessment (JCA) is an HTA process that aims to harmonize the clinical assessment of medicines and devices across the EU.

It provides a single point for the submission and compilation of clinical and safety evidence, which is then shared with the EU individual countries.

EU countries utilize the JCA outputs to make decisions on price, reimbursement, and funding in their markets.

The JCA will run in parallel alongside the European Medicines Agency’s marketing authorization application process.

The JCA applies to all new medical products approved by the European Medicines Agency from:

SOLUTIONS

RPN executes the JCA process assisting in:

Predict PICOs: Anticipate likely PICOs and develop SLR in advance of JCA final scoping
Validate anticipated PICOs though KOL network and early dialog in local markets
Conduct SLRs to PICOs, generate comparative effectiveness data, and consolidate in JCA dossier
Manage JCA process
Local HTA submissions: JCA evidence will be seamlessly merged with economic evidence to satisfy HTA

Pharmaceutical & BioTech