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 European-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 Europe.
• 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 Europe that would impact clinical research and technology organizations.

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

• ACRO Recommendations to Independent Review of the State of Commercial Clinical Trials in the UK 

European Commission

• ACRO Request for Clarification of ‘Health Institution’ Definition in IVDR Regulation
• 2023 Survey on the Implementation of the Clinical Trials Regulation
• Multi-Stakeholder Recommendations for transitioning Clinical Trials from the Clinical Trials Directive to the Clinical Trials Regulation
• European Commission Survey on ACT EU Agenda and Priorities
• Multi-stakeholder open letter expressing concerns regarding the impact of IVDR implementation on patient access to clinical trials

European Health Data Space (EHDS)

• Supplemental Statement on the Draft EHDS Regulation (May 2023)

EMA

• Multi-Stakeholder Request to Prioritize IVDR/CTR interface under ACT-EU

ICH

• ICH Reflection Paper on Harmonization of RWE Terminology
• ICH M11 Clinical Electronic Structured Harmonised Protocol – Template
• ICH M11 Clinical Electronic Structured Harmonised Protocol – Guideline

2022

EMA

• Public Consultation Concerning the Physical Attendance and the Location Of Personal Residency of the Qualified Person (EMA/INS/169000/2022)
• EMA Draft Guidance on the Protection of Personal Data and Commercially Confidential Information in Documents Uploaded and Published in the CTIS (EMA/212507/2021)

2021

EMA

• Comment on EMA Draft Guideline on Computerised Systems and Electronic Data in Clinical Trials (EMA/226170/2021)
• Requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials (EMA/CHMP/QWP/31884/2021)
• Requirements for quality documentation concerning biological investigational medicinal products in clinical trials (EMA/CHMP/BWP/534898/2008 rev. 2 corrigendum)

European Commission

• Supplemental comment on European Commission Consultation on the Revision of the General Pharmaceutical Legislation
• Online Survey Consultation on European Health Data Space (July 2021)
• ACRO Policy Recommendations for Guidance on Electronic Systems and Electronic Data in Clinical Trials

2020

European Data Protection Board

• ACRO joins with EFPIA and the IPMPC in comment to European Data Protection Board

EMA

• The use of rSDV and the recent guidance on the management of clinical trials during the COVID-19 pandemic (15/09/20)
• The General Data Protection Regulation (GDPR) Secondary Use of Health Data for Medicines and Public Health Purposes (16/07/20)
• Feedback on Guidance on the Management of Clinical Trials during the COVID 19 (Coronavirus) pandemic Version 2 (27/03/2020)
• EMA Draft Guidance on Points to Consider on implications of Coronavirus disease (COVID-19) on methodological aspects of ongoing clinical trials (EMA/158330/2020) Joint Industry Comment Letter from EFPIA, ACRO, EuropaBio, Vaccines Europe, EFSPI, and EUCROF 
• European Medicines Agencies Network Strategy to 2025

2019

EMA

• Comments on eSource Direct Data Capture (DDC) qualification opinion (EMA/282576/2018)
• Guideline on the evaluation of medicinal products indicated for treatment of bacterial infections, Rev. 3
• Public consultation on EMA Regulatory Science to 2025 (EMA online survey)
• Comments on draft Guideline on the quality requirements for drug-device combinations (EMA/CHMP/QWP/BWP/259165/2019)

UK House of Commons

• House of Commons Science and Technology Committee: Brexit, Science and Innovation: Preparations for ‘No-Deal’ inquiry

2018

EMA

• EMA draft revision: Guideline on safety and efficacy follow-up and risk management of Advanced Therapy Medicinal Products (EMEA/149995/2008 rev.1)
• ICH E9 (R1) addendum: Estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials (EMA/CHMP/ICH/436221/2017)
• EMA Draft reflection paper: Investigation of pharmacokinetics and pharmacodynamics in the obese population
• Draft Guideline: Responsibilities of the sponsor: Handling and shipping of investigational medicinal products for human use in accordance with Good Clinical Practice and Good Manufacturing Practice
• Concept paper: Preparation of a revised guideline on the evaluation of medicinal products indicated for treatment of bacterial infections
• EMA Draft addendum to the guideline on the Evaluation of medicinal products indicated for treatment of bacterial infections to address paediatric-specific clinical data requirements (EMA/CHMP/187859/2017)

Article 29 Data Protection Working Party

• Comments on Article 29 Working Party Guidelines on Transparency under the GDPR (WP260)

European Commission

• European Commission consultation: Good Clinical Practice (GCP) for advanced therapy medicinal products (ATMPs)

UK House of Commons

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

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

UK Medicines and Healthcare Products Regulatory Agency (MHRA)

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

2017

EMA

• Guideline on Strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products
• EMA draft guideline: Multiplicity issues in clinical trials
• Draft guideline: Good clinical practice compliance in relation to trial master file (TMF) for content, management, archiving, audit and inspection of clinical trials
• Concept paper: Guideline on the evaluation of medicinal products indicated for treatment of influenza
• Concept paper: Revision of the guideline on the role of pharmacokinetics in the development of medicinal products in the paediatric population
• Draft guideline: Notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol
• Concept paper: Revision of the guideline on clinical development of vaccines
• Concept paper: Predictive biomarker-based assay development in the context of drug development and lifecycle
• Reflection paper: The use of extrapolation in the development of medicines for paediatrics

ICH

• ICH E11(R1) guideline on clinical investigation of medicinal products in the pediatric population: Step 2b
• Reflection paper: Good Clinical Practice (GCP) “Renovation”

UK House of Commons

• Brexit – medicines, medical devices and substances of human origin inquiry – Regulatory arrangements needed to guarantee safe and effective supply of medicines, medical devices and products post-Brexit

2016

EMA

• Draft Guidance: Post-authorisation efficacy studies
• Draft Guidance: Good pharmacovigilance practices (GVP) Module V – Risk management systems (Rev 2)
• Draft Guidance: Format of the risk management plan (RMP) in the EU – in integrated format (Rev2)
• Concept paper: Strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicinal products
• Guideline: Requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials
• Draft Guideline: Requirements for quality documentation concerning biological investigational medicinal products in clinical trials

European Commission

• Ethical considerations for clinical trials on medicinal products conducted with minors
• Risk Proportionate approaches in clinical trials
• Summary of Clinical Trial Results for Laypersons
• Definition of Investigational Medicinal Products (IMPs) and use of Auxiliary Medicinal Products (AMPs)

ICH

• E6(R2) Integrated Addendum: Good Clinical Practice
• ICH Guideline E18 on genomic sampling and management of genomic data
• ICH E17 General Priniciples for Planning and Design of Multi-Regional Clinical Trials

UK MHRA

• MHRA GxP Data Integrity Definitions and Guidance for Industry

UK House of Commons

• Inquiry on Leaving the EU: Implications and Opportunities for Science and Research

2015

EMA

• Guidance on the procedural aspects related to the submission of clinical reports for the purpose of publication in accordance with EMA policy 0070
• GVP Module VIII Addendum I – Requirements for transmission of information on non-interventional post-authorisation safety studies (Rev 2)
• GVP Module VIII – Post-authorisation safety studies (Rev 2)
• Concept paper: Revision of the guideline on the requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials
• EU Medicines Agencies Network Strategy to 2020 – Working together to improve health
• EU Telematics Strategy and Implementation Roadmap 2015-2017
• Draft proposal for an addendum to the Functional specifications for the EU portal and EU database to be audited

European Commission

• Commission Delegated Act on principles and guidelines on good manufacturing practice for investigational medicinal products and on inspection procedures, pursuant to the first subparagraph of Article 63(1) of Regulation (EU) No 536/2014
• Commission Guidelines: Good manufacturing practice for investigational medicinal products, pursuant to the second subparagraph of Article 63(1) of Regulation (EU) No 536/2014
• Public consultation on detailed arrangements for clinical trial inspection procedures including the qualification and training requirements for inspectors pursuant to Article 78(7) of Regulation (EU) No 536/2014

United Kingdom (UK) Health Research Authority

• UK policy framework for health and social care research – Version 1.0 (February 2015) – HRA 2015 informal request for comments, preceding formal public consultation period in 2016