The reporting of suspected adverse drug reactions contributes to a better characterisation of a medicinal product's safety profile as well as to more reliable conclusions regarding its benefit-risk ratio. Thus, this information helps other patients but also e.g. prescribing physicians to select the most suitable treatment. Lastly, healthcare professionals should also report suspected cases to the respective drug commission.

The first standard German Pharmacopoeia was published 150 years ago after the establishment of the German Reich. The 1872 edition, titled "Pharmacopoea Germanica", was still written in Latin. One and a half centuries later the pharmacopoeia has remained indispensable for pharmaceutics, but is now primarily relevant in its European Version.

Clinical trials are a prerequisite for medical progress. They offer patients a chance at early access to innovative therapeutic options as new treatment possibilities are introduced into medical practice. Prof. Karl Broich, President of the BfArM explains why Europe is such an important environment for clinical trials and what changes are necessary with regard to authorisation procedures.

... and tips from the responsible BfArM assessor on how to avoid them.

The Health Data Lab (HDL; German: Forschungsdatenzentrum Gesundheit) at the BfArM aims at converting highly sensitive health data into new, "synthetic" datasets for anonymisation purposes. The use of this data is supposed to take place in virtual environments - protected areas where researchers can then examine the data with the help of artificial intelligence.

Doctoral candidate Julia Wicherski investigates the use of fluoroquinolones

We know how to DiGA: Balance sheet for the directory anniversary

#1 Harald Enzmann, Chairman of the EMA Committee for Medicinal Products for Human Use