Legislation and Regulation in the EU

European Regulatory Comments

ACRO European Regulatory Comments

As part of its advocacy program in Europe, ACRO submits regulatory comments to both European regulators – such as the European Medicines Agency (EMA), the European Commission, and the International Conference on Harmonisation (ICH) – and, on occasion, to national authorities in the Member States.

ACRO’s European regulatory comments are included here in reverse chronological order, organized by Agency.

2018 Comments

EMA

Article 29 Data Protection Working Party

European Commission

  • European Commission consultation document on good clinical practice (GCP) for advanced therapy medicinal products (ATMPs) [link]

UK House of Commons

  • House of Commons Health and Social Care Committee Inquiry: Impact of a No Deal Brexit on Health and Social Care [link]

UK Department of Health

  • ACRO Policy Recommendations Letter, Submitted to Lord O’Shaughnessy, Parliamentary Under Secretary of State for Health, in follow up to 24 October Clinical Research Roundtable [link]

UK Medicines and Healthcare Products Regulatory Agency (MHRA)

  • MHRA consultation on EU exit no-deal legislative proposals – ACRO response to Clinical Trials Section only [link]

2017 Comments

EMA

ICH

UK House of Commons

2016 Comments

EMA

European Commission

ICH

UK MHRA

UK House of Commons

2015 Comments

EMA

European Commission

United Kingdom (UK) Health Research Authority