PIPA PHARMACOVIGILANCE SYSTEM MASTER FILE WORKING GROUP By Sarah Hall PSMF Working Group: Sarah Hall, Mipsol Limited (Chair) Valentina Mancini, Shionogi (Vice Chair) Margherita D’Antuono, Italfarmaco Dora Amene, TMC Pharma
John Barber, Plain Pharma Ilaria Grisoni, Jazz Pharmaceuticals Anne Lloyd, Ethypharm Vasavi Garlapalli, Novartis
With more countries and regions requiring a Pharmacovigilance System Master File (PSMF), and following a suggestion from delegates at the 4th European Pharmacovigilance Congress, PIPA set up a PSMF Working Group to develop guidance for the PIPA membership. This article provides a bit more detail about the Working Group as well as the results of the PIPA PSMF survey. Introduction
there are not enough details about the French PV system in an MAH’s EU PSMF. In addition, there are countries elsewhere in the world where the maintenance of a PSMF, or similar document, is a voluntary obligation.
The European Union (EU) requirement for a Pharmacovigilance System Master File (PSMF) to be maintained by all Marketing Authorisation Holders (MAHs), and made available upon request, has been in place since July 2012. It replaced the Description of the Pharmacovigilance System (DDPS) that was submitted with each new licence application and the Summary of Pharmacovigilance System (SPS) that was requested at the time of a Pharmacovigilance (PV) inspection. The PSMF is used for PV System oversight by the Qualified Person for Pharmacovigilance (QPPV), a tool for audit and inspection planning, and allows Competent Authorities to assess an MAH’s PV System during Marketing Authorisation applications and post-authorisation.
With the more complex and ever changing PSMF landscape, companies are trying to determine how to meet global PSMF requirements whilst limiting the amount of duplication of effort. Following a suggestion from delegates at the fourth European Pharmacovigilance Congress, where a PIPA update was presented by Sarah Hall, the PIPA PSMF Working Group (PSMF WG) has been set up. The members of the PSMF WG have been involved in PSMF development and maintenance since 2012, have experience of development of PSMFs in numerous regions/territories and one has recently been through a successful MHRA PV inspection with a UK PSMF. The intention is to develop PSMF guidance for the PIPA membership.
For almost ten years we have developed and maintained our EU PSMFs, sharing best practice and learning from inspection findings. More recently other countries and regions have implemented similar legislation including the requirement to have an Arab Region PSMF since 2015 (or Pharmacovigilance Sub System File (PSSF) for multinational companies) and a United Kingdom of Great Britain and Northern Ireland (UK) PSMF since 1st January 2021. There are also specifics relating to EU Member States such as the requirement by the Agence nationale de sécurité du médicament et des produits de santé (ANSM) for the inclusion of a French addendum if
We want to make sure the guidance is as helpful as possible so, in July 2021, we created a survey to ask you, the PIPA membership, what your experience of PSMFs is, what you would like to see in a PSMF guidance document and areas that you consider to be the greatest challenges. We were pleased to receive 50 responses and would like to thank those of you who took the time to answer 8
