• 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.