Health Technology Assessment

Health Technology Assessment: The Commission opens first request submission period for joint scientific consultations

The European Commission has launched the first request submission period for joint scientific consultations (JSCs) under the Health Technology Assessment Regulation (EU) 2021/2282. The JSCs enable health technology developers (HTDs) to exchange information with regulatory authorities on their development plans for a medicinal product or medical device. They also enable HTDs to obtain guidance on …

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Health Technology Assessment – Commission adopts rules for joint scientific consultations on medical devices and in vitro diagnostic medical devices

The European Commission adopted an implementing regulation establishing the rules for joint scientific consultations on medical devices and in vitro diagnostic medical devices, under the Health Technology Assessment (HTA) Regulation. The implementing act provides detailed procedural rules for the joint scientific consultations, also known as scientific advice, covering: the submission of requests from health technology …

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New EU rules on Health Technology Assessment open up a new era for patient access to innovation

The Regulation on Health Technology Assessment (HTA) has become applicable, bringing a significant improvement in ensuring that innovative and effective health technologies are available to patients across the EU. The new rules create an EU framework for the assessment of health technologies, such as medicines and medical devices, by fostering collaboration and coordination between EU Member States. This …

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Health Technology Assessment – Commission adopts rules for joint scientific consultations on medicinal products for human use

The European Commission adopted an implementing regulation setting out the rules for joint scientific consultations on medicinal products for human use at Union level, under the Health Technology Assessment (HTA) Regulation. The implementing act provides detailed procedural rules for the joint scientific consultations, also known as scientific advice, covering: the submission of requests from health …

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