Automatic substitution with biosimilars by pharmacies should start next month in Germany – How will it work?
On 16 Aug 2019, the GSAV came into force. This new law also included legislation with the aim to increase the market
Category: Directives
Virtual consultations for patients with Covid-19 requiring intensive care introduced into routine clinical practice
During the pandemic, the G-BA introduced special regulations for hospital care. Based on their good experiences with these, the G-BA has now
Minimum case numbers in Germany
Welcome again! We are extending the short excursion to quality assurance today with a look at minimum case numbers in Germany. In
Which quality requirements apply to ATMPs in Germany?
Welcome to the second post in the quality assurance series, focusing on the hot topic of ATMPs! Next week, I’ll be focusing
Switching between original biologics and biosimilars in Germany
Biosimilars are biological drugs that are highly similar to another biological medicine, the so-called originator. The biosimilars have no clinically meaningful differences to
The G-BA accepts treatment per video call
Introduction of DVPMG law On 9 June 2021, the law on the digital modernization of care (DVPMG) came into force. The key
The G-BA specifies QA requirements for cell and gene therapies in Germany
In the previous assessments of Kymriah, Yescarta, Tecartus, and Zolgensma, the G-BA had defined specific QA requirements for the use of these
Change in morbidity factor means more GPs are needed in Germany
Identifying amount of required healthcare The G-BA developed the needs planning directive (German: Bedarfsplanungs-Richtlinie) to give national rules on “how much” SHI-funded