Improvement of GSAV Regulations – A BPI Response
The Bundestag Health Committee is seeking to clarify the Gesetz für mehr Sicherheit in der Arzneimittelversorgung (GSAV), (Greater Security in … read more »
GSAV: What impact will it have on OMP registries in Germany? And how should those registries be designed?
As reported previously, the Federal Joint Committee (GBA) will likely request registry data for most orphan medicinal product (OMPs) launched in … read more »
GKV-FKG Bill brings significant changes for cell & gene therapies in Germany
The Federal Ministry of Health in Germany (BMG) has recently introduced a bill which intends to reform the risk-pool RSA … read more »
BfArM share preparations for Brexit
The Federal Institute for Drugs and Medical Devices (BfArM) has shared its preparations for Brexit, highlighting its preparations for the … read more »
Bundesrat advises on GSAV
The Federal Council (Bundesrat) met this week to discuss the GSAV law currently under debate in Germany. Their meeting has … read more »
TSVG law adopted by Bundestag
The Bundestag (German Federal Parliament) has passed the Terminservice und Versorgungsgesetz (TSVG) law regarding tendering for certain medical devices, the … read more »
Federal Joint Committee announce 2019 projects
The Federal Joint Committee (G-BA), the supreme decision-making body of health professionals, hospitals and insurance funds in Germany, has issued … read more »
Germany launches Global Health Hub, aiming at international cooperation & digitalisation
Global Health Hub Germany was launched in Berlin last week, bringing together over 200 international members with the goal of … read more »
Falsified Medicines Directive in the news: ABPI concerns and the German perspective
With the Falsified Medicines Directive (FMD) coming into full force tomorrow (9 February 2019), two stories have highlighted the need … read more »
Second draft of the Law for more safety in the supply of pharmaceuticals (GSAV) approved by the German Federal Cabinet
In response to drug scandals in Germany this year, including the possible contamination of drugs with potentially carcinogenic substances and … read more »
