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Pharma Business EU Sets The Stage For Increased Pharmacovigilance Oversight And Harmonization By Amanda Sibley W ith the overarching goal of improving transparency and accountability, the European Medicines Agency (EMA) has been taking a more comprehensive approach to pharmacovigilance, introducing a set of good pharmacovigilance practice (GVP) guidelines to the European market. Integral to the GVP guidelines was the introduction of the pharmacovigilance system master file, or PSMF, which is a detailed description of the pharmacovigilance system used by the marketing authorization holder (MAH) with respect to the holder's authorized medicinal products. The PSMF has been required for new marketing authorization applications since July 2012; it will be optional for existing applications until July 2015. The PSMF is much more than a regulatory document. It describes in detail every aspect of the way a company handles a product's pharmacovigilance and safety in general. In so doing, it serves as a useful and robust tool for both regulators and the MAH by ensuring that all aspects of GVP are being practiced, that there is clearer structure to the management of product safety issues, and that noncompliance issues or deficiencies in the pharmacovigilance system will get detected. In addition, complex and constantly changing regulations require higher levels of interdisciplinary expertise, which in turn increases the need for good tools to detect and respond to safety concerns. Yet many life sciences companies remain reluctant to introduce the PSMF — in part because the 2015 deadline for compliance makes it 46 LifeScienceLeader.com seem less urgent, and in part because the new GVP guidelines require investment in training relevant staff, which can be costly. UNDERSTANDING THE HOW AND WHY Before introduction of the PSMF, companies were required to maintain two documents: the Detailed Description of the Pharmacovigilance System (DDPS) and the Summary of Pharmacovigilance Systems (SPS). The DDPS was submitted with the license, and the SPS was requested by inspectors before inspection. Producing two documents led to companies' duplication of effort, but perhaps more important, neither document provided the needed oversight or level of detail regarding pharmacovigilance activities, nor did either include the detailed compliance metrics that are integral in the new pharmacovigilance document. The PSMF reflects the existing pharmacovigilance system of a product and must be maintained and submitted to authorities upon request, thereby making it transparent and accountable. The document must be available to the assessors within seven days of a request. A document that does not include sufficient details regarding the existing pharmacovigilance system as defined in PSMF GVP Module II could trigger a safety inspection. What that means in February 2014 practice is that the PSMF should be permanently available for inspection. Preauthorization inspections are possible for those MAHs that are new to submitting of centralized applications in Europe. Upon submission of a marketing authorization application, a Summary of Pharmacovigilance Systems has to be submitted, and the PSMF produced upon request. Failure to comply with such a request would result in an inspection finding, as was revealed during the GPvP Symposium in London in March 2013. The MAH should continue submitting variations to update the DDPS for existing marketing authorizations when a system summary has been submitted in a new marketing authorization application but not yet introduced for all products. WHAT THE PSMF DOES The PSMF is intended to be a live, bespoke document that accurately reflects the pharmacovigilance system that is in place for a given product. The PSMF provides insight into timelines, roles and responsibilities, interfaces between the various pharmacovigilance departments, review of frequency of the process documents, validation of status of the safety database, a description of online data management tools, persons responsible for the various pharmacovigilance processes, and key performance indicators.