Module A: Introduction to EU regulatory affairs

The first module of the ERA course focuses on understanding the basic structure of the regulatory system. We will discuss topics such as: the evolution of the regulation of medicines in the European Union (EU); the role of the European Medicines Agency (EMA) and national agencies; and the relevant legislative frameworks.

Learning objectives

After this module you will be able to:

  • Summarize the EU’s role in public health, the goals of the internal market and how it relates to   pharmaceuticals.
  • Outline the evolution of the regulatory system in Europe, including some historical pre-EMA procedures.
  • Identify the responsibilities of the EMA and understand how it is organized.
  • Summarize EMA’s role in current topics such early access to medicines, transparency of trial data and the legislation linked to it.
  • Outline the centralized procedure and other European registration procedures.
  • Describe lifecycle management of the benefit-risk profile of a medicinal product as a key activity of drug regulators.
  • Explain the necessity of collaboration between regulators, academia, HTA and clinicians to fuel policy & R&D decision-making.
  • Describe the scientific basis of regulatory affairs, and the necessity of regulatory science for innovation within the regulatory system and healthcare policy.
  • Understand the key challenges in the European legislative framework for medicines, and be able to name the most important court decisions, for example around the following:
    • New chemical entities and their legal implications
    • Parallel trade and re-packaging
    • Advertising
    • Off-label prescribing.