Legislation & Regulation

Legislation and Regulation in the EU

In addition to working with policy makers and regulatory agencies in the United States, ACRO and its member companies also engage in a number of efforts in the European Union and the EU member states.

With nearly 30 percent of all clinical trials taking place in EU, it is critical to ensure regulatory structures and research quality standards are in place to support the advancement of clinical research and protect patients across Europe.

To that end, ACRO:

  • Supports the European Medicines Agency in  its efforts to advance Good Clinical Practice (GCP) compliance and enhance international inspection efforts and responds to public consultations impacting the CRO industry.
  • Supports and responds to the European Commission in its development of legislation and supports the European Parliament and the Council of the European Union in their passage and adoption of legislation.
  • Builds relationships with the national competent authorities in the European Union (EU) and European Economic Area (EEA) that are responsible for human medicines
  • Works with European officials to  strengthen and refine the EU Clinical Trial Regulation
  • Promotes appropriate privacy and data protection regimes to facilitate research – including working with European officials to strengthen and refine the General Data Protection Regulation
  • Advocates for a competitive business environment for clinical trials in the EU
  • Works collaboratively with colleague associations in the EU – on identified issues of mutual interest – to combine our strengths into a unified and coordinated message to policymakers

Read our full history of regulatory comments on proposed guidances and rules in the European Union that would impact clinical research organizations.

Read more about ACRO’s legislative and regulatory policy goals: