What is Regulatory Intelligence in Pharmacovigilance?
In Pharmacovigilance (PV), Regulatory Intelligence involves the collection and analysis of publicly accessible PV regulatory guidelines and regulations, articulating the significance of this information, vigilantly tracking the prevailing regulatory landscape and its impact on company’s current processes.
Regulatory intelligence involves staying compliant and current with evolving regulatory standards set forth by governments and regulatory bodies. These apply to medicinal products, vaccines and medical devices in development and authorized on the market. Consequently, it is crucial to routinely screen and evaluate newly introduced or modified regulatory information in Pharmacovigilance (PV) to gauge its potential impact on company standards and the overarching pharmacovigilance strategy. It is also essential to conduct and document impact assessment and communicate these updates to the internal and external stakeholders.
Ensuring alignment with regulatory authorities
Ensuring alignment with regulatory requirements is critical in pharmacovigilance. 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. Given that product approvals may span multiple countries and the scope of applicable pharmacovigilance agreements (PVA) extends globally, it is essential to stay informed about regulatory changes that impact both your company and those of your PVA partners.
Identifying Key Areas of Interest
Various aspects of pharmacovigilance are screened within Regulatory Intelligence as areas of interest. They may include the need for a PV contact person, either local or regional, or a range of requirements, such as:
- Clinical trial and Post Marketing reporting requirements
- Good Clinical Practice and Inspections
- Risk Management Plans (RMP)
- Pharmacovigilance System Master File (PSMF)
Why is Regulatory Intelligence so Important?
All personnel involved in Pharmacovigilance (PV) activities must ensure full compliance with pertinent regulatory requirements. Failure to comply with these requirements and appropriately reporting adverse events and product complaints in accordance with regulatory statutes could adversely affect companies and compromise patient safety.
Failure to meet regulatory requirements can lead to various adverse outcomes, including delays in the approval process for new medicinal products or medical devices, or even product withdrawal. In the most severe cases, non-compliance may result in legal actions, such as penal sanctions and financial penalties, as well as significant reputational damage. Therefore, staying abreast of current regulatory requirements is crucial, as the consequences of non-compliance can be profound.
Gaining PV Regulatory Intelligence with ProPharma
Our Regulatory Intelligence team leverages PV intelligence not only to stay informed about external regulatory changes but also to ensure our internal knowledge and activities remains current and compliant. This includes staying updated on roles such as Qualified Persons for Pharmacovigilance (QPPVs), Local Persons for Pharmacovigilance (LPPVs), and other relevant positions within our organization.
Each time a new project commences, the Project Lead assesses the necessary Regulatory Intelligence screening activities required for the project.
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 screening activities may also be conducted by LPPVs, particularly if they possess proficiency in the local language. They are responsible for communicating any new or modified PV-relevant regulatory information to our PV regulatory intelligence team for review and impact assessment.
The Project Lead, QPPV, or LPPV may also be responsible for communicating Regulatory Intelligence updates to clients or other third parties as required and if specified in the contract. These updates are also communicated internally to all PV employees and other interested parties within ProPharma.
ProPharma provides comprehensive Regulatory Intelligence services, which can be customized to meet the unique needs of clients regarding content, frequency, and communication methods. If you're interested in discovering how our Regulatory Intelligence team can assist you in staying up-to-date and compliant with regulatory requirements and updates, please don't hesitate to get in touch with us. We're here to help!
