Health Technology Appraisal in EU – Scientific Advice EU

A prerequisite for a Parallel EMA-HTA body Scientific Advice is that the pivotal clinical trial (pivotal phase II/ or III) has not yet started. Contact Justin Stindt Consultants, your trusted market access service provider, if you would like to know further eligibility criteria details.

Enhancing Drug Development Efficiency: Benefits of the Parallel Joint Scientific Consultation Procedure with EMA and HTA Bodies

The main benefits of the parallel joint scientific consultation procedure include:

• Streamlined procedure for applicants
• Increased mutual understanding and problem-solving ability between EMA and HTA bodies through a more structured interaction
• Improved coordination with, and greater participation of HTA bodies in parallel consultations through EUnetHTA 21’s Committee for Scientific Quality & Consistency in its configuration for Joint Scientific Consultations (CSCQ JSC)
• More efficient use of resources
• Routine participation and interaction with patient representatives and healthcare professionals

For all submitted requests, the G-BA (Gemeinsamer Bundesausschuss / Federal Joint Committee, Germany), referred to as the “HTA Coordination Contact”, facilitates the centralised HTA recruitment for the benefit of the requesting company. Note that a minimum of two HTA bodies may participate on a voluntary basis. Otherwise, the request will continue as an EMA-only scientific advice. Contact our consulting firm if you would like our team to help submit a Parallel EMA-HTA body scientific advice request. At the conclusion of the process, developers will be issued a scientific advisory letter from EMA, along with personalized written suggestions from the involved HTA organizations.

EMA’s Pilot Program for High-Risk Medical Devices: Expert Panel Scientific Advice and Consultation

EMA is running a pilot that enables the expert panels to provide scientific advice for manufacturers of high-risk medical devices (all class III devices and class IIb active devices intended to administer and/or remove medicinal products from the body). Contact our international consulting agency if you would like to know more information on the pilot, its eligibility criteria, or how to submit your letter of interest.

Health Technology Assessment Coordination Group (HTACG): Streamlining JSC and JCA Processes in the EU from 2025

From January 2025 onwards, JSC will be conducted by the Health Technology Assessment Coordination Group (HTACG), which was established by the regulation on Health Technology Assessment (HTAR). The subgroup for Joint Scientific Consultations will assist the HTACG. The Coordination Group will bring together various national health technology assessment (HTA) bodies and experts from different EU countries. By pooling resources and expertise, JSC will offer an efficient approach to receiving feedback on companies’ evidence-generation plans. The HTACG will provide expertise on HTA for both medicinal products and medical devices (the latter covering also in vitro diagnostic medical devices). Pharma, biotech and MedTech companies will also be able to request a Joint Clinical Assessment (JCA) from the Coordination Group. For more information visit our Joint Clinical Assessment (JCA) in the EU: Advancing Collaborative Evaluation of Innovative Therapies page.