European Pharmacovigilance and Drug Safety Compliance

Navigating through the EU pharmacovigilance system can be challenging because the system has a steep learning curve. At SJ Pharma Consulting, LLC in Mendham, NJ, we can provide you with information and training on all aspects of the European pharmacovigilance and drug safety compliance.

Our team can guide you through the entire process and provide the tools necessary to complete each step. With our help, you can efficiently introduce your new product into the market and have a clear understanding of the follow-up procedure.

Furthermore, our company has conducted more than 100 pharmacovigilance audits of pharmaceutical companies. We have confirmed their compliance with relevant US, EU, and international laws, regulations, and guidance.

Understanding the EU Pharmacovigilance System

Pharmaceutical companies must comply with numerous regulations and guidance for them to be able to legally develop and market their products. Achieving this becomes more difficult because of the differences in the regulations and guidance of each country as well as the ongoing changes to the requirements.

Some of the biggest alterations to the pharmacovigilance regulations that have recently transpired are those of the European Union. In 2012, the EU's new standards began to go into effect. However, these standards have not been fully implemented yet, and they continue to change. These constant regulation updates have made the pharmacovigilance requirements more complex.


The Required Steps Before the New EU Legislation

  • Data Collection and Management
  • Signal Detection
  • Safety Issue Evaluation
  • Benefit Risk Management
  • Regulatory Action
  • Communication
  • Audit

Why Were the Standards Changed?

One of the reasons that made the European pharmacovigilance process difficult before is how the procedures were divided. The steps listed above were originally split between pharmaceutical firms, the European Medicine Agency, national competent authorities, healthcare professionals, and patients.

On the surface, this seemed to be a good safety net. However, the reality was that roughly 5% of hospital deaths and about 200,000 deaths in the EU were due to side effects. To reduce the number of deaths caused by adverse reactions, new pharmacovigilance standards were developed.

The New Pharmacovigilance Standards

  • Providing Transparent Roles and Well-Understood Responsibilities for the Various Actors
  • Ensuring the EU Has Strong Decision-Making Processes
  • Engaging With Health Care Professionals and Patients in the System Throughout the Entire Process
  • Requiring That All Pharmacovigilance Is Science-Based, Involving a Clear Display of Benefits and Risks
  • Strengthening Companies' Pharmacovigilance Systems
  • Checking That All Products Are Risk-Proportionate

We'll Make Sure You Meet the Requirements

Although the regulations are stricter and the weight of the pharmacovigilance requirements is greater, the EU Medicines Agency has enhanced their coordination with all the parties involved. At SJ Pharma Consulting, LLC, we can help you understand and follow the new procedures.

For example, one of the requirements is that each new product needs to have a risk management plan. This plan involves proactive data collection when the company introduces the product to the market. As a result, the level of risk is reduced. Post-deployment studies are also required to determine the efficacy and safety of each product.

Let us help ensure that your business meets all EU regulatory requirements. We offer in-person and online training courses for pharmacovigilance and drug safety. Contact us today to learn more about how we can serve you.