By Niels Grønning and Thomas Hornbæk Svendsen, Life Sciences Industry Experts at NNIT
Since the implementation of Directive 2010/84 and Regulation 1235/2010, marketing authori zation holders (MAHs) with products on the European market are obliged to maintain, and make available upon request, a Pharma covigilance System Master File (PSMF). The PSMF comprises a range of annexes supported by a main document that, in its entirety, encapsulates the respective MAHs approach to continuous monitoring of a given product’s riskbenefit balance.
Since the effective date (July 2012) of Module II of the Guidelines on Good Pharmacovigilance Practices (GVP), MAHs have struggled to ensure compliance with the new legislation. The com- prehensiveness of the PSMF and the vast sourc- es of data that are required to fulfill the legisla- tive requirements, place MAHs under pressure in terms of resources and lack of operational business processes that support the subsequent maintenance.
Of importance is the requirement for oversight in terms of source data, where individual case safety reports (ICSRs) may be received. This includes clinical studies, registries, market research programs (MRPs), and patient support programs (PSPs), and necessitates that the MAH has established a business process that captures this data from affiliates, or is able to extract the source data from existing IT systems. Data extraction from existing systems may, however, pose a challenge in terms of data quality and could potentially lead to the inclusion of incon- sistent data in the PSMF.
On an organizational level, MAHs are obliged to ensure full oversight with local affiliates, includ- ing any service providers where contractual agreements directly or indirectly relate to the fulfillment of pharmacovigilance obligations. The MAH is, in turn, now fully responsible for all activities outsourced to third party service providers in terms of safety.
Pharmaceutical companies, which have not yet established tools/processes to ensure that the required source data is collected and continu- ously monitored, have difficulties in guaranteeing that the PSMF consistently reflects the current state of the companies’ pharmacovigilance systems.
But how do companies ensure that the PSMF and corresponding annexes are continuously updated and successfully reflect a company’s pharmacovigilance system? Furthermore, how does an organization successfully implement and maintain a PSMF without the need for additional resources?
The successful implementation and maintenance of a PSMF largely depends on the respective companies’ internal knowledge of organizational set-up, IT landscape (including data), and maturity. The following steps may serve as a model to ensure that PSMF establishment and maintenance limits resource implications, while ensuring full legislative compliance.
With the above in mind, any organization will be able to embrace the challenges associated with establishment and maintenance of a PSMF, without experiencing departmental constraints and non-compliance.