D7.1 Guidance for the interaction between HTD and HTA (for JCA and JSC)

D7.1

This EUnetHTA 21 deliverable (D7.1) focusses on the guidance for the interaction between HTA experts and Health Technology Developer (HTD) during Joint Clinical Assessments (JCA)/Collaborative Assessments (CA) and Joint Scientific Consultations (JSC).

The objectives of this deliverable are to:

  • Produce a practical guidance for HTA/HTD interaction, by defining objectives and extent of interaction between HTA agencies and HTD for JCA/CA and JSC.
  • Define a process for handling commercially sensitive and academic in-confidence data.  
  • Create a procedure and framework for the factual accuracy check (if decided to continue this as a process step) if HTD have submitted a dossier.  
  • Update the Frequently Asked Questions and procedure manual of JA3 to increase awareness and understanding of the JCA/CA procedures for HTD.  
  • Provide a definition of an incomplete Submission Dossier and outline  a procedure for managing incomplete submissions.  

The public consultation for this specific deliverable is foreseen to take place in the period between 20-07-2022 and 19-08-2022. 

For any questions regarding this deliverable, please contact JCA_Secretariat@zinl.nl

Below you can find the published documentation:

D7.1 Guidance for the interaction between HTD and HTA (for JCA and JSC) – Project Plan