PV Regulatory Intelligence and its Growing Importance

Pharmacovigilance (PV) Regulatory Intelligence is the activity of gathering, summarising and interpreting available regulatory information relating to pharmacovigilance requirements. Its fundamental goal is to keep up to date and operate in line with the latest PV requirements implemented by governments and competent authorities.

PV regulatory intelligence is a critical activity for any clinical trial Sponsor or medicinal product Marketing Authorisation Holder. It helps ensure product and patient safety compliance while developing or commercialising medicinal products or medical devices. Due to ever-changing legislation and guidelines, all safety-related changes must be continuously monitored and evaluated for potential impact on the PV system and safety processes.

European Medicines Agency (EMA) is the central authority governing PV in the European Union (EU) and releasing regional legislation and guidelines. In addition to the central requirements from EMA, the EU member states also have local legislative requirements on a country level. The same applies to other regional unions like the Eurasian Economic Union (EAEU) and any individual country across the world. Therefore it is essential to gather PV regulatory intelligence not only from central bodies, like the EMA, but also from National Competent Authorities in the countries where the clinical trial is run and/or a medicinal product is authorised.

Generally, two directions of PV regulatory intelligence should be established:

1. Central regulatory intelligence – the monitoring of central regulatory bodies and legislations, such as EMA, FDA, MHRA, WHO, ICH, and others.
2. Local regulatory intelligence – the monitoring of local regulatory bodies and legislations, such as National Competent Authority websites/announcements and local legislation changes.

Regulatory intelligence can encompass a broad spectrum of PV duties and responsibilities. The essential and the minimum requirements that one must maintain oversight on include:

• Expedited regulatory reporting (domestic vs foreign ICSRs, serious vs non-serious, listed/nonlisted, expected/unexpected);
• Aggregate reporting requirements (PSUR/PBRER, DSUR);
• Global and local PSMF requirements;
• Global or regional QPPV (e.g. EU-QPPV, EAEU-QPPV) requirements;
• Local Person for Pharmacovigilance (LPPV) requirements;
• Local requirements for additional risk minimisation measures (educational materials);

A proper regulatory intelligence system is an increasing demand from PV regulators and inspectors. Today, more often than ever, inspection findings are raised due to the insufficient PV regulatory intelligence process. And to no surprise, the PV regulatory environment is being continuously improved and strengthened across all regions. It is an obvious challenge for pharmaceutical companies to notice each change in each country duly on time. Especially considering this, in most cases, requires a significant amount of qualified resources with intimate knowledge of the local legislations and different national languages.

Regulatory Intelligence is one of the services proposed by Insuvia. Our PV experts (QPPVs, LPPVs, PV Specialists) constantly monitor the legislative environment and escalate changes at all levels. We provide central oversight of regional/global requirements and utilise our Local PV infrastructure and LPPVs (Local Persons for Pharmacovigilance) to gather local PV regulatory intelligence from National Competent Authorities. Should you have requirements or would like to learn more about our regulatory intelligence process – please feel free to contact us. We would be glad to have a discussion.

If you have any questions don’t hesitate to contact us.