Signal-Management
Qualitätsgesicherte kontinuierliche Nutzen-Risiko-Bewertung von Arzneimitteln in der Praxis
europharm
Abstract
Signal Management / Practical application of quality assured continuous benefit-risk assessment for medicinal products
Since the introduction of Directive 2010/84/EU in the year 2010 continuous benefit-risk assessment (CoBRA®) of medicinal products has been a key procedure of a compliant pharmacovigilance system. Marketing authorisation holders as well as the QPPV have to ensure that competent authorities can be provided with current data regarding a product's benefit-risk ratio at any time. Signals do not only arise from spontaneous case reports, but also, especially with regard to substances which have been marketed for some time, from the scientific and medical literature. It is therefore crucial to implement a well-organised process to analyse information from different sources which also include information from competent authorities and data from own clinical studies. According to the „Guideline on good pharmacovigilance practices“, Module IX, this process has to meet high quality standards.
Applicable laws and guidelines do not contain much practice-oriented detail on how such a process should look like. This article provides an overview of legal requirements for and performance of a signal management process as well as synergies with PSUR and RMP preparation with a focus on identifying signals from the scientific literature and on interfaces with competent authorities.
Zusammenfassung
Bereits 2010 haben das Europäische Parlament und der Rat die kontinuierliche Nutzen-Risiko-Analyse von Arzneimitteln in der Richtlinie 2010/84/EU als Schlüsselelement eines Pharmakovigilanz (PV)-Systems festgelegt. Daraus ergibt sich für den Zulassungsinhaber und die QPPV die Pflicht sicherzustellen, dass aktuelle Daten zum Nutzen-Risiko-Verhältnis den zuständigen Behörden jederzeit vorgelegt werden können. Da Signale sich nicht nur aus Spontanfällen, sondern gerade für schon länger im Markt befindliche Substanzen aus der wissenschaftlich-medizinischen
