Legislation & Regulation

Legislation and Regulation in the EU

With nearly 30 percent of all clinical trials taking place in Europe, ACRO engages with regulators to support – and provide CRO expertise on – harmonization efforts such as the EU Clinical Trial Regulation and the EU General Data Protection Regulation (GDPR).

EU Engagement Activities

  • Participate in invitation-only, recurring EMA stakeholder meetings on the development of the EU portal and database, and provide Subject Matter Experts to invitation-only workshops and forums on specific issues such as pharmacovigilance.
  • Provide CRO expertise to the European Commission on the implementation of the Clinical Trial Regulation.
  • Build relationships with the national competent authorities that are responsible for human medicines.
  • Meet with the European Data Protection Supervisor (EDPS) to promote appropriate privacy and data protection regimes that protect data subjects and also facilitate research, including GDPR.
  • Advocate for a competitive business environment for clinical trial placement in the EU.
  • Collaborate with colleague associations such as the European Federation of Pharmaceutical Industries and Associations (EFPIA) on issues of common interest to present 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: