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Drug safety: Strengthen trust through strict controls!
Find out how drug safety is ensured in the EU and what role pharmaceutical companies and authorities play.
Drug safety: Strengthen trust through strict controls!
On September 15, 2025, drug safety will once again be the focus of discussion. Ensuring the effectiveness and safety of medications is an ongoing challenge for the pharmaceutical industry. OTS reports that responsibility for medicines from clinical development to use lies in the hands of industry. Patient safety remains a central issue in drug development.
Comprehensive monitoring systems accompany the life cycle of a medication and ensure that reports of side effects and interactions as well as medication errors are systematically recorded, analyzed and evaluated. The Paul Ehrlich Institute (PEI) emphasizes that knowledge about the safety of a drug is often incomplete at the time of approval. Clinical trials are carried out on a relatively small number of patients, which means that rare undesirable effects are often not detected.
The role of pharmacovigilance
The topic of pharmacovigilance, i.e. the ongoing and systematic monitoring of drug safety, is regulated by law in the EU. The BfArM explains that clinical trial sponsors have obligations to promptly report possible safety issues. This includes reporting serious adverse drug reactions (SUSARs) within strict time limits.
Important new findings about a drug can lead to a changed benefit-risk profile after approval. At a minimum, pharmaceutical companies are expected to promptly communicate safety-related information to healthcare professionals, for example through Red Hand letters. This is intended to provide patients and healthcare professionals with timely information.
Trust through security and transparency
Continuous evaluation and risk minimization of medicines are crucial to strengthening public confidence in medicine safety. The responsible authorities check compliance with legal requirements and regularly evaluate the systems. In order to support the safe use of medication, doctors and pharmacists are provided with targeted information.
Another goal is to make security-relevant information available digitally and in a targeted manner. Digitalization offers enormous potential for drug safety and enables a faster response to new findings.
In summary, the safety of medicines is a lifelong focus and should be ensured through strict quality controls, comprehensive monitoring systems and close cooperation between the pharmaceutical industry and the authorities.