Why local knowledge is key to global pharmacovigilance outcomes

There is no issue more important to health authorities than patient safety. This has led to pharmacovigilance (PV) being one of the most highly regulated fields, with strict yet often differing expectations from local authorities. At the same time, we are witnessing growing efforts by marketing authorisation holders (MAHs) to standardise their regulated activities with the aim of enhancing processes and outcomes.

The challenge for companies is to ensure their local affiliates meet local PV obligations while staying aligned with global PV requirements. Often, however, companies lack PV expertise at the local level and struggle to achieve a coordinated approach to global PV operations, which results in inefficiencies, delays or non-compliance.

Barriers at the local level
The burden on the local affiliate can be enormous. In smaller markets in particular, local staff often wear many hats, managing regulatory, quality and medical affairs activities as well as meeting commercial objectives. Many lack the level of PV expertise needed and can’t give these activities their full attention.

Often PV management at the central level is not aware of the local requirements, which can vary significantly from one country to the next, even within markets like the EU, or how certain business models might impact local PV expectations.

Lack of standardisation also puts pressure on local affiliates who must comply with global PV standards while also adapting to their country’s regulatory requirements.

In some cases, pharmaceutical companies may rely on third-party vendors to manage local PV activities. Ensuring that these external entities adhere to the same high compliance standards is a significant challenge. Mismanagement by third parties can lead to non-compliance issues for which the MAH remains accountable, as spelled out by regulatory authorities. Companies must therefore ensure they maintain full oversight of the pharmacovigilance system master file (PSMF).

Navigating divergent PV requirements
Globalisation has led the industry to expand into many markets, each of which has its own set of PV regulations. These can differ quite significantly in terms of reporting timelines for adverse events, requirements concerning documentation and formats, language requirements and risk management plans specific to local populations. Keeping track of and complying with these points of difference can be challenging.

By way of example, in the Middle East and Africa region there are quite significant differences between countries. PV regulations in countries such as Saudi Arabia, South Africa and Egypt are developed and strict, while some countries have only started their PV journey in the last few years and others have no clear regulations at all.

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