Why do you need local regulatory intelligence in pharma sector?
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11 Mar Why do you need local regulatory intelligence in pharma sector?

Posted at 10:00h in Legislation, Problem-Solution, Regulatory Affairs by

Regulatory Intelligence, as a systematic approach, includes the processes of regularly and proactively collecting regulatory information and analysing the latest updates that impact the operations of an organization. Regulatory Intelligence helps companies cope with the dynamics in regulations, accommodate changes, and ensure compliance.

On February 23, 2024, Bulgaria introduced amendments to the Law on Medicinal Products in Human Medicine (LMPHU). These changes further tighten the tracking and reporting of medicinal products that are subject to reimbursement with public funds via the electronic systems of the engaged health authorities. These rules potentially could impact the reimbursement of medicinal products in case of non-compliance.

It is just a recent example of how local Regulatory Intelligence could play a critical role in the complex landscape of pharma regulations and cases like the one above shows its importance in several directions.

  • Navigating regulatory complexity
    Regulatory Intelligence helps companies stay informed about regulatory changes, reducing the risk of costly mistakes and ensuring compliance.
  • Risk mitigation and efficiency
    By monitoring regulatory updates, organizations can swiftly adapt to changes. This proactive approach minimizes compliance risks, avoiding industry sanctions or penalties.
  • Strategic decision-making
    Regulatory Intelligence plays a pivotal role in highly regulated fields, such as pharmaceuticals, medical devices, and accompanying healthcare-related services. Regulatory Intelligence isn’t just about data collection; it’s about analysing and processing information. An effective regulatory strategy emerges from Regulatory Intelligence, guiding decisions across disciplines—from manufacturing to marketing.

 

Why local Regulatory Intelligence matters?

As an example of the dynamics at national level, here are three of the key legislative acts in Bulgaria impacting the pharma sector and the number of amendments over time:

  • Health Act – 104 amendments (Aug. 2004 – Dec. 2023)
  • Medicinal Products in Human Medicine Act – 39 amendments (Apr. 2007– Feb. 2024)
  • Health Insurance Act – 131 amendments (Jun. 1998 – Feb. 2024)

 

How do we do it?

At PharmDedict, Regulatory Intelligence processes are ensured by the involvement of experienced personnel, including two experts with a legal background. We carefully monitor selected sources of regulatory information and are supported using specialised legal software. We maintain a full track record in an audit-ready manner, and we also provide our clients with impact analyses.

Curious how to start with local Regulatory Intelligence?