Key insights from the new draft regulation on the communication with the European Medicines Agency
The new Joint Clinical Assessment (JCA) and Joint Scientific Consultation (JSC) initiatives, which are part of the European-wide Health Technology
The US Inflation Reduction Act – key changes to Pricing & Reimbursement of medicines in the USA you need to know about
The Inflation Reduction Act (IRA), signed into law in August 2022, is a piece of legislation aimed at addressing several
Mehr als 330 erstattete produkte im rahmen des französischen härtefallprogramms/early access programms (atu/aap)
Frankreichs Reimbursed Early Access Programs (EAP) ermöglichen die Erstattung neuer Arzneimittel vor der regulären Erstattung (sogar vor der Marktzulassung) und
New 2024 Italian AIFA Commission CSE Up and Running – Insights from First Meetings
The updated regulations are effective immediately upon their publication in Italy’s Official Journal. The new 2024 Italian AIFA Commission, known
Introducing the Joint Clinical Assessment (JCA) in the EU: Aiming to Enhance Access to Innovative Therapies but Risking to Duplicate HTA for the Industry
The Joint Clinical Assessment (JCA) process in the European Union marks a significant advancement in the evaluation of innovative therapies
Pricing and Reimbursement France – Securing Early Reimbursement Through the Early Access Programs
France’s Reimbursed Early Access Programs (EAPs) allow for reimbursement of new medicines before traditional reimbursement and even before Marketing Authorization.
