EU Commission launch today Public Consultation on Health Technology Assessment (HTA) Implementing Regulation

EU Commission launch today Public Consultation on Health Technology Assessment (HTA) Implementing Regulation

Pierre Mermet-Bouvier Pierre Mermet-Bouvier

Pierre Mermet-Bouvier

eCOAs I Regulatory Affairs I Transparency I PMO I Regulatory Intelligence I Clinical Operations I Global and Transversal Teams I Process Improvement I Operational Excellence I Strategic Planning

发布日期: 2024年3月5日
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Today, the EU Commission launch a Public Consultation on a Health Technology Assessment (HTA) Commission Implementing Regulation.

The following documents for review were released:

  • COMMISSION IMPLEMENTING REGULATION (EU) …/... of XXX laying down, pursuant to Regulation (EU) 2021/2282 on health technology assessment, procedural rules for the interaction during, exchange of information on, and participation in, the preparation and update of joint clinical assessments of medicinal products for human use at Union level, as well as templates for those joint clinical assessments (18 pages)
  • ANNEXES 1 to 3 (20 pages):
  • ANNEX I: TEMPLATE FOR THE DOSSIER OF THE JOINT CLINICAL ASSESSMENT OF A MEDICINAL PRODUCT
  • ANNEX II: TEMPLATE FOR THE JOINT CLINICAL ASSESSMENT REPORT
  • ANNEX III: TEMPLATE FOR THE JOINT CLINICAL ASSESSMENT SUMMARY REPORT

The feedback period is ending 02Apr24.

https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13708-Health-technology-assessment-joint-clinical-assessments-of-medicinal-products_en


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