Zolgensma First To Be Subject To New German Data Collection Rules
Pricing And Reimbursement Body Sets Out New Process
The G-BA has explained in more detail the procedures for mandating post-launch evidence generation under new legislation introduced in 2019.
You may also be interested in...
A new bill going through the German legislative process could oblige manufacturers of orphan drugs and certain other products to submit real-world data from registries that would impact pricing.
Industry access to real world data for regulatory and market access purposes in Asia Pacific compares poorly with the US.
Draft guidelines due out for consultation this week in Italy are expected to shed more light on what companies will have to reveal during pricing and reimbursement negotiations.