Expert EU HTA Regulation Services

The EU HTA regulation aims to enhance access to medicines for patients across EU member states, foster collaboration on HTA among member states at a European level, reduce duplication of work by enabling sponsors to submit clinical evidence for assessment only once, harmonize methodological standards and ease the reimbursement process in markets with limited HTA infrastructure.

A Joint Clinical Assessment (JCA) is a regulatory requirement under the EU HTA Regulation, analyzing the available clinical evidence on a health technology in comparison with one or more other health technologies or existing procedures.

As of January 12th, 2025, JCA will come into effect in the European Union for newly authorized oncology products and advanced therapy medical products (ATMPs), and orphan drugs (2028) will follow as part of a phased approach. JCA will be required for all new medicinal products by 2030. The Member State Coordination Group on Health Technology Assessment (HTACG) Annual Work Program estimated that 17 JCAs for oncology medicines and 8 JCAs for ATMPs will be initiated. The final number of JCAs will depend on the formal marketing authorization applications submitted to the EMA.

Certara provides end-to-end support, including workshops and training on EU HTA regulation, PICO scenario planning, data review and evidence synthesis to identify and fill data gaps, comparative effectiveness research, and writing and compilation of the JCA EU HTA submission dossier.

The EU offer of Joint Scientific Consultation (JSC) either as multi-HTA or as multi-HTA/EMA parallel scientific consultation is an opportunity for health technology developers to seek advice in early development phases which is critical for planning purposes, and future assessments, prior to the start of pivotal trials.