The Pharmacovigilance System Master File (PSMF)

The European Medicines Agency (EMA) has introduced a set of good pharmacovigilance practice (GVP) guidelines to the European market. This is another effort to improve transparency and accountability in the sector.

Together with these guidelines, EMA has also introduced 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. New marketing authorization applications since July 2012 will require the PSMF.

The pharmacovigilance system master file is actually a detailed description of the pharmacovigilance and safety procedures which a company follows when handling a product. It is a very useful document for the regulators and the MAH which ensures that noncompliance issues or deficiencies in the pharmacovigilance system will get detected.

Though the introduction of PSMF from EMA seems like a great thing towards improving safety, many companies are reluctant to introduce it within their structures. This is partly because the deadline for doing this is 2015 and partly because they will need to train their staff.

Up till now there were two main documents required from companies: 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.

The new PSMF should be always available for inspection and if it does not include the necessary details regarding the existing pharmacovigilance system as defined in PSMF GVP Module II the company may expect an inspection.