Effective Pharmacovigilance System Development: EFPIA-IPVG Consensus Recommendations

Tanja Peters, Nigel Soanes, Maya Abbas, Jabeen Ahmad, Jean-Christophe Delumeau (), Esteban Herrero-Martinez, Mélanie Paramananda, Johanna Piper, Fairouz Smail-Aoudia, Willemijn Spuij, Tina Veizovic and Gillian Winstanley
Additional contact information
Tanja Peters: Boehringer Ingelheim
Nigel Soanes: AstraZeneca PLC
Maya Abbas: Johnson & Johnson Middle East
Jabeen Ahmad: Innovate PV
Jean-Christophe Delumeau: Bayer Pharma
Esteban Herrero-Martinez: AbbVie Ltd
Mélanie Paramananda: Pierre Fabre Médicament
Johanna Piper: Roche Products Ltd
Fairouz Smail-Aoudia: Pierre Fabre Médicament
Willemijn Spuij: Bristol Myers Squibb
Tina Veizovic: Takeda
Gillian Winstanley: Amgen Canada Inc

Drug Safety, 2021, vol. 44, issue 1, No 3, 17-28

Abstract: 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.

Date: 2021
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DOI: 10.1007/s40264-020-01008-0

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