EU Joint Clinical Assessment (JCA) – implications for Pharma and Medtech
Summary
Maria Dimitrova (Consultant – HTA) and Samantha Gillard (Director – HTA) provide an overview of the EU Joint Clinical Assessment (JCA) and what it means for Pharma and Medical Device manufacturers launching new technologies from 2025.- Author Company: Mtech Access
- Author Name: Samantha Gillard
- Author Email: info@mtechaccess.co.uk
- Author Website: https://mtechaccess.co.uk/
What is the EU JCA?
In January 2022, the European Parliament enacted a new EU Health Technology Assessment (HTA) Regulation, with the aim of standardising clinical assessment of medicines and high-risk medical devices across the EU and avoiding duplication of work.
Currently, Pharma and Medtech manufacturers have to submit evidence individually in each of the 27 EU markets; the intention of the JCA is that at least some of the assessment can be done centrally.
The JCA report will act as a universal information source for relative treatment effects, safety, and other clinical parameters agreed in the scoping process. The report will also cover the clinical area addressed by the technology and its technical characteristics.
The introduction of the JCA should also benefit smaller markets, which may not have the required capacity or expertise to conduct assessments independently.
Read the full article at: https://mtechaccess.co.uk/eu-jca/
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