Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

An insight into the post-approval safety surveillance of medicinal products in the three ICH regions (EU, Japan and USA) - with particular focus on the management of safety signals ***

Nathalie Welter (Abschlußjahr: 2015)

Summary
Language: English
During the development of medicinal products it is not possible to identify all potential safety concerns. Especially less frequent adverse drug reactions are unlikely to be observed during the clinical development, which is mainly due to the limited number of patients treated. For this reason post-authorisation safety surveillance is of paramount importance to ensure patient safety.
The essential tasks in post-authorisation safety surveillance are the identification of new or changing safety concerns and the subsequent, systematic evaluation followed by adequate action with regard to risk minimisation activities. The detection of potential safety signals presents an early stage in the examination of possible safety concerns. Typically the need for further evaluation is justified, but it is not clear if a “real” risk with clinical relevance exists and if any regulatory action is warranted. The management of safety signals can be regarded as the basis of pharmacovigilance activities and belongs to the most important performances in post-authorisation safety surveillance systems.
The European Union, Japan and the United States of America, the founding members of the International Conference on Harmonisation (ICH), have established pharmaceutical regulatory systems of the highest level worldwide. Their pharmacovigilance systems are not only based on long-standing experiences, but also on empirical knowledge gained from intensive international collaboration and cooperation. The competent regulatory authorities have made significant progress in the past years in reinforcing their post-authorisation safety surveillance systems, including an accelerated identification and processing of potential safety signals, increasingly efficient procedures and more pre-emptive approaches. Amongst others this has been achieved by several legislative amendments in order to increase the vigilance of the pharmacovigilance systems and hereby enhance the safety of medicinal products and deliver an improved protection of public health.
The present master thesis intends to provide an insight into the post-authorisation safety surveillance for medicinal products in the European Union, Japan and the United States of America and constitute a comparison of the signal management systems in the three ICH regions.
Pages: 60, Annexes: 9 pages