European Legislation and Regulation
Advancing Industry Interests in European 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).
Read ACRO’s full history of regulatory comments on proposed guidances and rules in Europe that would impact clinical research and technology organizations.
European 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 European regulatory comments are listed below.
Contact us for more information about our European advocacy.
2023
United Kingdom
European Commission
European Health Data Space (EHDS)
EMA
ICH
2022
EMA
2021
EMA
European Commission
2020
European Data Protection Board
EMA
2019
EMA
UK House of Commons
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)
2017
EMA
ICH
UK House of Commons
2016
EMA
European Commission
ICH
UK MHRA
UK House of Commons
2015
EMA
European Commission
United Kingdom (UK) Health Research Authority