What is Regulatory Intelligence in Pharmacovigilance?
In Pharmacovigilance (PV), Regulatory Intelligence is the act of gathering and analyzing publicly available regulatory information, communicating the implications of that information, and monitoring the current regulatory environment.
Regulatory intelligence is about remaining up to date with changing regulatory requirements as implemented by governments and regulatory authorities. These apply to both medicinal products and medical devices in development and authorized on the market. This means that new or changed PV-relevant regulatory information needs to be screened and assessed routinely for potential impact on company procedures and overall pharmacovigilance strategy. An impact assessment needs to be performed and documented, and Regulatory Intelligence activities need to be communicated to stakeholders.
Aligning with Regulatory Authorities
For the 27 member states of the European Union, the European Medicines Agency (EMA) is responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU, and communication about European legislation. Within the EMA, member states can have their own additional local guidelines for these EU member states. In other countries, local requirements apply.
For the US and Canada, the Food and Drug Administration (FDA) and Health Canada are responsible for regulatory promulgation and oversight. Depending on which countries a product is approved in and the reach of applicable pharmacovigilance agreements (PVA) across the globe, it is imperative to keep abreast of changes affecting both your firm and those of your PVA partners.
Identifying Key Areas of interest
Areas of interest that are screened in Regulatory Intelligence include many aspects of pharmacovigilance. They may include the need for a PV contact person, either local or regional, or a range of requirements, such as:
- Individual Case Safety Reports (ICSR)
- Periodic Safety Update Reports (PSUR)
- Risk Management Plans (RMP)
- Pharmacovigilance System Master File (PSMF)
Why is it so important?
Of course, everyone working in PV should be compliant with all relevant regulatory requirements. If requirements are not strictly followed and (potential) adverse events and product complaints are not noted or processed according to regulatory legislation, this may have a negative impact on companies and, in the end, patients’ safety.
If the requirements are not met, this may result in delay in approvals for new medicinal products or medical devices, or withdrawal of the product. In a worst-case scenario, it may result in legal proceedings with penal sanctions and pecuniary penalties, and reputational damage. So, not being up to date with current regulatory requirements may potentially have profound consequences.
Gaining PV Regulatory Intelligence with ProPharma
ProPharma manages PV Regulatory Intelligence for many clients. Our team also utilizes Regulatory Intelligence to keep our own internal knowledge up to date, e.g., of QPPVs (Qualified Persons for Pharmacovigilance), LPPVs (Local Persons for Pharmacovigilance), and others.
Every time we begin a new project, the Project Lead identifies which Regulatory Intelligence screening activities are needed.
Then the Regulatory Intelligence screening activities are performed. Relevant sources are screened and any new or changed PV-relevant regulatory information is identified, which is then documented. An impact assessment is performed for the relevant information. A Subject Matter Expert on the relevant area of interest may be involved in this assessment. Stakeholders are informed of its outcome and the country specific PV requirements are updated, if necessary.
The actual screening activities may also be carried out by LPPVs, for example because they are more proficient in the local language. They communicate new or changed PV-relevant regulatory information to either the Project Lead or the QPPV.
The Project Lead, the QPPV, or LPPV also communicates Regulatory Intelligence updates to clients or other third parties. These updates are also communicated internally to all PV employees and other interested parties within ProPharma.
ProPharma has an extensive Regulatory Intelligence system in place, which may be tailored to clients’ needs in terms of content, frequency, and mode of communication. If you wish to learn more about our Regulatory Intelligence Services, please contact our team today.
