The European joint clinical assessment (JCA) becomes mandatory for all oncology drugs and ATMPs from 2025 on, for orphan drugs from 2028 on and for all drugs registered centrally by the EMA from 2030 on.

The EU HTA pathway

The JCA Process - FAQ

  • The JCA is a collaborative initiative among EU member states to streamline the clinical assessment of health technologies.

A: The JCA covers a wide range of health technologies, including pharmaceuticals, medical devices, and in vitro diagnostics.

A: The objective of the JCA is to facilitate the timely and coordinated assessment of health technologies to support informed decision-making and improve patient access.

A: The JCA involves a harmonized assessment process where member states collaborate to evaluate the clinical evidence and value of health technologies.

A: EU member states participate in the JCA, along with relevant stakeholders such as regulatory agencies, health technology assessment bodies, and patient representatives.

A: No, the JCA does not replace national processes. It aims to complement existing procedures by providing a framework for collaboration and information sharing.

A: The JCA aims to expedite patient access to innovative and effective health technologies by promoting a more efficient and coordinated assessment process.

A: The EMA contributes to the JCA by providing scientific expertise and coordinating activities related to the assessment of pharmaceuticals.

A: The JCA does not directly conduct clinical trials. It relies on the data generated from clinical trials conducted by manufacturers and sponsors.

A: The assessments conducted through the JCA inform national decision-making processes regarding regulatory approval, reimbursement, and patient access.

A: The JCA is a voluntary collaboration, and participation by member states is not mandatory. However, the aim is to achieve broad participation.

A: The JCA is primarily focused on EU member states, but non-EU countries may participate as observers or in specific collaborations.

A: The JCA follows strict data protection regulations and ensures the confidentiality, integrity, and security of all shared data.

A: Patient representatives are involved in the JCA process, providing input and insights on the patient experience and preferences.

A: Industry stakeholders, such as pharmaceutical companies and medical device manufacturers, may contribute data and expertise to the JCA process.

A: The JCA provides evidence and information that can inform pricing and reimbursement decisions at the national level, but those decisions remain the responsibility of individual member states.

A: The JCA and EUnetHTA are complementary initiatives that aim to align and improve health technology assessment processes across Europe.

A: The JCA’s assessments may contribute to the regulatory decision-making process by providing additional evidence and insights.

A: The JCA can assess both new and existing health technologies, depending on the needs and priorities of member states.

A: The JCA supports the EU’s objective of promoting access to safe, effective, and affordable health technologies while ensuring patient safety and quality of care.