4 minute read
PIPA Pharmacovigilance System Master File Working Group
By Sarah Hall
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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
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. 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 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. 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. 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
our questions. Responses were generally in line with the thoughts of the PSMF WG so that was reassuring.
Survey responses
We will consider all the responses when developing the guidance, but here is a headline summary. 47 of the 50 respondents are involved in development or maintenance of their company’s PSMF. In terms of content of the guidance document, 17 people would like clarity on development of the UK PSMF and how to address UK and EU PSMF requirements due to the Northern Ireland Protocol, 9 would like guidance on areas of the PSMF that are identical for all territories versus the information that needs to be specific for a given country or region and 23 requested more general PSMF guidance such as annex management and practical tips and advice on PSMF development and maintenance. The ‘great unanswered questions’ included what the appropriate level of detail should be, what should go in the body versus annexes and how frequently the PSMF should be updated. 15 respondents considered the greatest challenge to be getting input from other functions and collecting data from multiple stakeholders. The number of PSMFs being managed by respondent companies ranged from one to more than ten with PSMFs mainly for EU and UK, but also covering Switzerland, Arab States, Ghana, Nigeria, Malaysia and Latin America. Of those companies that have PSMFs covering the UK and EU, almost half had a joint EU/UK PSMF. Several respondents asked for a PSMF template. However, we won’t be developing a PSMF template as part of the guidance. The reason for this (and why a template isn’t provided as part of the Guidelines on good pharmacovigilance practices (GVP)) is because PV Systems are so different and a template would be too restrictive. Having said that, we will include example tables and other guidance to try to help address this request as much as we consider appropriate.
Conclusion
As mentioned previously, the members of the PSMF WG have a wealth of PSMF experience between them. However, the landscape continues to change and we are still learning about the ‘new’ PSMFs such as the UK PSMF. For this reason, the guidance will be a ‘live’ document with updates as the MHRA releases details of UK PSMF inspection findings and guidance is released by other Competent Authorities. We are hoping to release the first version of the Guidance Notes in early 2022. We’re also considering PSMF workshops or a training course to complement the current PSMF face to face training course. So watch this space and if you have any comments or suggestions, please contact the PSMF WG via pipa@pipaonline.org
Sarah Hall
Director MIPSOL Limited
