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Review
. 2021 Jan;44(1):17-28.
doi: 10.1007/s40264-020-01008-0. Epub 2020 Dec 8.

Effective Pharmacovigilance System Development: EFPIA-IPVG Consensus Recommendations

Tanja Peters  1 , Nigel Soanes  2 , Maya Abbas  3 , Jabeen Ahmad  4 , Jean-Christophe Delumeau  5 , Esteban Herrero-Martinez  6 , Mélanie Paramananda  7 , Johanna Piper  8 , Fairouz Smail-Aoudia  7 , Willemijn van der Spuij  9 , Tina Veizovic  10 , Gillian Winstanley  11 ; EFPIA International Pharmacovigilance Group
Affiliations
Review

Effective Pharmacovigilance System Development: EFPIA-IPVG Consensus Recommendations

Tanja Peters et al. Drug Saf. 2021 Jan.

Abstract

Pharmaceutical legislation provides a legal framework to ensure the safe and effective use of medicines. This framework requires national regulatory authorities (NRAs) to establish and maintain a pharmacovigilance system (PV system) stating and enforcing the regulatory commitments that key stakeholders, including marketing authorisation holders (MAHs), are required to fulfil. In recent years, national legislative bodies and NRAs across the world have issued a significant amount of legislation and guidance enforcing the obligation to perform pharmacovigilance activities. In countries where the NRA is a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), safety management requirements are generally consistent with ICH guidelines. In a number of countries beyond this scope, requirements may deviate from internationally agreed standards, adding a substantial complexity and increasing burden on the stakeholders involved, whilst the benefit for patients' safety may not be evident. Committed to fulfilling safety-regulatory obligations in any country where a product licence is held, global pharmaceutical companies have accumulated a broad and deep experience acquired whilst meeting the expectations of a large array of diverse PV systems across the world. These range from sub-optimal frameworks, according to the World Health Organization (WHO) Global Benchmarking Tool, to highly effective resource-optimised PV systems. In order to support countries creating or further developing their PV systems, especially where infrastructure and resources are limited, the European Federation of Pharmaceutical Industries and Associations (EFPIA) International Pharmacovigilance Group (IPVG) has developed consensus recommendations consistent with harmonised standards for the development and step-wise implementation of key PV system components. These recommendations endorsed by the EFPIA membership constitute the focus of this review article.

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Conflict of interest statement

Tanja Peters was employed at Boehringer Ingelheim at the time this research was completed. As of April 1, 2020, Tanja Peters is an employee of Merck Healthcare KGaA and owns stocks of Merck KGaA. Tanja Peters also conducts ancillary work with the Forum Institute for Professional Training in Heidelberg, Germany. Nigel Soanes is employed by AstraZeneca and has reported no additional conflicts of interest. Maya Abbas is employed by Johnson & Johnson Middle East and declares that she has no conflict of interest. Jabeen Ahmad was previously employed by AbbVie and Innovate PV during the writing of the manuscript. Jabeen is now employed by Roche and has reported no conflicts of interest. Jean-Christophe Delumeau is employed by Bayer, serving pro bono the International Society of Pharmacovigilance as a board and executive committee member. He has not reported additional conflicts of interest. Esteban Herrero-Martinez is employed by AbbVie and has reported no additional conflicts of interest. Mélanie Paramananda is employed by Pierre Fabre and has reported no additional conflicts of interest. Johanna Piper is employed by Roche Products Ltd and has reported no additional conflicts of interest. Fairouz Smail-Aoudia is employed by Pierre Fabre and has reported no additional conflicts of interest. Willemijn van der Spuij is employed by Bristol Myers Squibb and has reported no additional conflicts of interest. Tina Veizovic is employed by Takeda and has reported no additional conflicts of interest. Gillian Winstanley is employed by Amgen Canada Inc. and has reported no additional conflicts of interest.

Figures

Fig. 1
Fig. 1
Suggested national PV system priorities. ADR adverse drug reaction, ICSR individual case safety report, MAH marketing authorisation holder, NRA national regulatory authority, PV system pharmacovigilance system
See this image and copyright information in PMC

References

    1. World Health Organization. The importance of pharmacovigilance—safety monitoring of medicinal products. WHO. 2002. https://www.apps.who.int/medicinedocs/en/d/Js4893e/. Accessed 24 Jan 2020.
    1. World Health Organization. WHO Global Benchmarking Tool (GBT) for evaluation of national regulatory system of medical products, revision VI version 1. WHO. Nov 2018. https://www.who.int/medicines/areas/regulation/01_GBT_RS_RevVI.pdf. Accessed 24 Jan 2020.
    1. The Global Fund, World Health Organization. Minimum requirements for a functional pharmacovigilance system. WHO. 2010. https://www.who.int/medicines/areas/quality_safety/safety_efficacy/PV_Mi.... Accessed 24 Jan 2020.
    1. International Federation of Pharmaceutical Manufacturers & Associations. IFPMA Position Paper: Considerations for effective regulatory reliance—an Industry perspective. IFPMA. 2019. https://www.ifpma.org/resource-centre/ifpma-position-paper-on-regulatory.... Accessed 24 Jan 2020.
    1. International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use. E2D Post-approval safety data management: Note for guidance on definitions and standards for expedited reporting. ICH. 2003. https://www.ich.org/page/efficacy-guidelines. Accessed 24 Jan 2020.

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