Regulatory Intelligence (RI)
In the European Union, Marketing Authorization Holders (MAHs) are required to keep their documentation consistently up to date, as outlined in key legal texts like Directive 2001/83/EC and Regulation (EC) No 726/2004. These regulations emphasize the MAHs’ responsibility to maintain accurate and current records, ensuring the safety and effectiveness of their products. However, how can MAHs effectively meet these obligations? What systemic solutions should they implement, and what processes must be established to stay compliant?
The importance of Regulatory Intelligence
The key to staying compliant lies in implementing a robust Regulatory Intelligence (RI) process within the MAHs’ quality systems. Regulatory Intelligence involves continuous monitoring of competent authorities’ websites, which is crucial in today’s fast-paced pharmaceutical landscape, where regulations frequently change. An effective RI strategy is essential to keep up with the latest regulatory updates. Pharmacovigilance is one critical area that requires constant vigilance to meet evolving requirements, ensuring that MAHs remain aligned with current obligations. It’s important to note that MAHs can establish and maintain this process internally or partner with a trusted service provider who can handle the setup and manage daily Regulatory Intelligence activities.
What does the RI process at SciencePharma consist of?
MAHs that have entrusted their Regulatory Intelligence (RI) need SciencePharma to enjoy the peace of mind that comes from knowing their portfolios are meticulously monitored. We conduct systematic searches for medicinal products (including active pharmaceutical ingredients (APIs) and reference products) across a wide range of competent authorities websites. For instance, these include the Polish Regulatory Agency (URPLWMiPB), European Medicines Agency (EMA), Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), European Commission (EC), World Health Organization (WHO), Medicines and Healthcare products Regulatory Agency (MHRA), Food and Drug Administration (FDA), and others.
By staying on top of regulatory updates, case law, and interpretations, we help our clients avoid non-compliance risks. For example, failing to update product information, like leaflets or summaries of product characteristics, or following PRAC recommendations can have serious consequences. Outdated information can directly impact patient safety and, in the worst-case scenario, lead to the withdrawal of marketing authorization.
Why us?
In conclusion, with SciencePharma Clients are always promptly informed of any regulatory changes. We ensure the safety of our Clients’ products on the market and providing their peace of mind during Agency inspections.
Our Regulatory Intelligence process has been rigorously tested during multiple GVP inspections, refining our pharmacovigilance system to the highest standards.