EU Legislation and Regulation

Advancing Industry Interests in European Legislation and Regulation

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

ACRO’s EU-focused Activities

  • Participate in invitation-only, recurring EMA stakeholder meetings on the development of the EU clinical trial 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 ACRO’s full history of regulatory comments on proposed guidances and rules in the European Union that would impact clinical research and technology organizations.

European Union Regulatory Comments

As part of its European advocacy efforts, ACRO submits regulatory comments to European officials such as the European Medicines Agency (EMA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA). ACRO’s EU regulatory comments are listed below.

Contact us for more information about our EU advocacy.

2018

EMA

Article 29 Data Protection Working Party

European Commission

UK House of Commons

UK Department of Health

UK Medicines and Healthcare Products Regulatory Agency (MHRA)

2015

EMA

European Commission

United Kingdom (UK) Health Research Authority