This month, the European Council adopted the regulation on the EU-wide assessment of health technologies (EU-HTA). At the same time, the first call for applications is now open for scientific advice within the framework of EUnetHTA.
In the open call of the EUnetHTA 21 JSC Secretariat, pharmaceutical companies can apply for parallel consultations with the EUnetHTA 21 and the European Medicines Agency (EMA). The aim of the consultations is to provide non-binding, scientific advice regarding the design of clinical trials to generate high-quality data for future benefit assessments. The EUnetHTA 21 Joint Consortium will be led by the National Health Care Institute of the Netherlands (ZIN). The Joint Federal Committee (G-BA) in Germany acts as the secretariat of the joint scientific consultations. Applications can be submitted to the G-BA email address EUnetHTA21-JSC@g-ba.de until December 7, 2021.
Pediatric drug shortages: has the situation really improved? In recent years, Germany has faced shortages of essential medicines for children, including antipyretics and antibiotics. To encourage manufacturers to increase production and supply, the GKV-SV (GKV-Spitzenverband, German SHI association)…
Since the beginning of 2025, member states of the European Economic Area (EEA) have been working together on joint clinical assessments (JCA) of new medicines. Recently, the first 9 JCAs were announced, assessing 2 ATMPs with Orphan drug status and 7 oncologics. Germany, France, and Ireland are curr…
Products with initial market entry after January 1st, 2025 are now benefiting from less strict pricing guidelines if the studies used for AMNOG benefit assessment included ≥ 5 % German patients. The benefit will last for 3 years and can be maintained even afterwards for companies with active R&D…
Changes to the German pricing system for innovative drugs are now in effect due to the Medical Research Act (Medizinforschungsgesetz, MFG). As of January 1st, 2025, European reference prices will no longer be included in the price negotiations according to § 130b SGB V following AMNOG benefit assess…
