HTA GG publishes Guiding Principles on Data Transparency
The HTA GG, the Member State Coordination Group on Health Technology Assessment, has published Guiding Principles on Data Transparency. The purpose of the document is to provide general principles to be used when assessing requests for confidentiality from health technology developers within the context of joint clinical assessments within the context of Joint Clinical Assessments (JCA).
The document distinguishes between what
Q&A on general methodological and procedural issues for joint clinical assessments
The European Commission has published an updated version of its Questions and Answers on general methodological and procedural issues for joint clinical assessments. The Q&A includes responses to questions concerning:
New guidance on frequently asked questions about the publication of the Joint Clinical Assessment report
The European Commission has published a document addressing frequently asked questions about the publication of the Joint Clinical Assessment report. The guidance addresses questions including:
What documentation, other than the procedurally compliant JCA and summary report, that have been established in the course of a specific JCA procedure will be made publicly available;
Whether only the “core dossier” (without appendixes) will be made public;
Whether the clinical data included in the submission file to
HTA: New Opportunity to Apply for Joint Scientific Consultations
On 1st April 2026, the European Commission will open the second requaest period for joint scientific consultations (JSCs) for 2026. The purpose of the JSCs are to provide both marers and pharmaceutical companies with an opportunity to consult
Belgian health technology assessment (HTA) body to lead consortium of EU Member State HTA bodies carrying out joint clinical assessments (JCA) under the HTA Regulation.
The Belgian health technology assessment (HTA) body, INAMI-RIZIV, will lead the consortium of EU Member State HTA bodies that will carry out joint clinical assessments under the HTA Regulation.