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PSMF establishment and maintenance; business as usual?

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.

  • A sustainable PSMF process landscape may, in any pharmaceutical company, serve as  an excellent starting point when embarking on the establishment or maintenance of the PSMF. Knowledge of the organization, stake- holders, IT systems, data, and how these individually feed into the PSMF, relieves  some of the complexities that many compa- nies may face. A stakeholder analysis identi- fies the stakeholders involved in the PSMF process and visualizes the multiple depart- ments involved in delivering information for the PSMF.
  • The PSMF process landscape may later serve as the starting point when conducting an in-depth gap-analysis, with the primary objective of uncovering the presence (or absence) of data that directly feeds into the PSMF from the existing IT landscape (e.g., Regulatory Information Management System, Clinical Trial Management System, etc.). The secondary objective of the gap-analysis is to critically evaluate the current data quality, as this may be scrutinized as part of an inspec- tion. Data that populates the PSMF may, as stated above, be found in existing systems but is sometimes also used across GVP modules (e.g., post-authorization safety studies in Module V and annex C of the PSMF). The inclusion of additional GVP modules in the analysis is crucial to ensure that data, which is shared between the PSMF and other pharmacovigilance modules, is continuously updated. Furthermore, extract- ing existing data through customized report- ing is essential if the maintenance of the PSMF is to become “business as usual”  and have minimal impact on organizational resources. This may, however, not always be possible, and companies should, in turn, be willing to develop customized solutions that support the collection of specific affiliate data in a GxP validated environment, for example.
  • Lastly, the establishment of a governance model will serve to ensure that the final PSMF business process is aligned with responsibili- ties within the individual contributing depart- ments. The governance model ensures that the pharmacovigilance system performance (annex F) prevails and that defined KPIs are consistently met. More importantly, the governance model is critical to safeguard  that the business processes are continuously updated and agile enough to sustain legisla- tive, as well as internal, changes.

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.







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