Masterarbeit

The Company Core Data Sheet: From CIOMS to the implications of the new Pharmacovigilance Legislation ***

Dr. Anke Webler-Messenger (2014)

Summary
A medicinal product is approved based on the evaluation of its benefits versus its risks at the time of the initial marketing authorisation. As data available at that time is usually fairly limited and restricted to information gained from clinical studies in a well defined population, the evaluation of the benefit/risk ratio will need to continue during the whole life-cycle of a product taking into account any additional knowledge gained postmarketing. In order to ensure the safe and effective use of a medicinal product such information will also need to be appropriately reflected in the labelling documentation, i.e. the CCDS (Company Core Data Sheet), the EU SmPC and Package Leaflet.
The concept of a CCDS/CCSI (Company Core Safety Information) was first officially introduced in 1996 with ICH guideline E2C in the context of PSUR creation and then most significantly further evaluated with CIOMS’ work on the preparation of CCSI which established core principles of safety labeling that are to a vast extend still applicable today.
As such labelling has always been one of the cornerstones of pharmacovigilance risk management, but with the changes introduced with the new Pharmacovigilance Legislation in 2010 and its amendment in 2012, this role has become even more prominent. Even though no dedicated GVP module on the CCDS/labeling source documentation has been created, the role of labelling as a risk minimisation tool becomes very apparent in a number of other GVP modules, e.g. signal management, Pharmacovigilance audits, Periodic Safety Update Reports etc.
Even though the core principles established mainly by the CIOMS working group are still applicable, its limitations also become evident, especially with the most recent pharmacovigilance developments, but also from a legal and more practical/implementation perspective. Such limitations include the implementation of the CCSI principle within a pharmaceutical company across different countries, but also liability questions when deciding what to label and how. With regard to the new Pharmacovigilance Legislation requirements have shifted from the sole evaluation of the risks related to the use of a medicinal product to the consideration of its benefits. Especially when looking at the requirements now detailed for RMPs and PSURs/PBRERs not solely safety-, but also efficacy-relevant considerations will gain importance and it will be interesting to see if and how this will be reflected in a company’s labelling documentation in the future.
Pages: 74