Regulations & Guidance feature in our Q1 Industry Update from Christina Hägglund, QA Manager S-cubed Ltd.
COVID-19 Guidance & Information
Europe & World
- Global Regulators Build Confidence in COVID-19 Vaccines: ICMRA statement for healthcare professionals: How COVID-19 will be regulated for safety ad effectiveness | International Coalition of Medicines Regulatory authorities (ICMRA)
- European Medicines Agency (EMA) Safety Monitoring Plan and Risk Management for Vaccines
- EMA Pharmacovigilance Plan of EU Regulatory Network for Vaccines
- EMA Update on COVID-19 Vaccines: Treatments and vaccines for COVID-19 | European Medicines Agency (europa.eu)
- Medicines and Healthcare products Regulatory Agency (MHRA) – Guidance on Minimising Disruption to the Conduct and Integrity of Clinical Trials
MHRA Guidance Documents
- The MHRA has published guidance for industry to be followed from 01 January 2021. The guidance is divided into subsections – Clinical Trials; Devices; Importing and exporting; IT systems; Legislation; Licensing; Pharmacovigilance and Paediatrics.
- Pharmacovigilance requirements for UK authorised products’ MHRA Inspectorate Blog
Brexit Notice of Medicinal Products
- The European Commission (EC) has published guidance for markets historically dependent on medicines supply from (or through) Great Britain
Regulations & Guidance
Proposed Revision of ICH Q9(R1) Quality Risk Management
ICH Reflection Paper on Advancing Patient Focused Drug Development
EU Clinical Trial Regulation (CTR)
The EMA management board has confirmed that the first phase of the Clinical Trial Information System (CTIS) audit has been completed (the CTR becomes applicable 6 months after the EC confirms the full functionality of the CTIS). The focus is now on the quality and stability of the system and on improving usability, performance and reliability.
The go-live date for the CTIS is December 2021. There is an option to subscribe to the quarterly CTIS Highlights Newsletter (go to ‘Progress updates’ section)
Pharmacovigilance Guidance for Public Consultation
- Module XVI ‘Risk minimisation measures: selection of tools and effectiveness indicators’ Guideline on Good Pharmacovigilance Practice (GVP) is anticipated to come into effect Q4 2021 to Q1 2022.
Post-Authorisation Procedural Advice for Users of the Centralised Procedure
- This guidance document addresses a number of questions which Marketing Authorisation Holders (MAHs) may have on post-authorisation procedures. It provides an overview of the EMA’s position on frequent and common issues. Questions and answers are continuously being updated and will be marked by “NEW” or “Rev.” with the relevant date upon publication.
Assent / Informed Consent Guidance for Paediatric Clinical Trials
Genetically Modified Cells
- The EMA has developed a guideline on the quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells. It comes into effect 01 June 2021.
- Overview of guidance documents expected during 2021.
- To interact with the FDA for Complex Innovative Trial Designs for Drugs and Biological Products
- Certificates of Confidentiality
- Enhancing Diversity of Clinical Trial Population
Access to Electronic Health Records (EHRs)
- The following guidance for on-site access to EHRs by Sponsor representatives has been jointly developed by the Health Research Authority (HRA) and the MHRA, as well as in consultation with the Information Commissioners Office (ICO), on behalf of the UK.
European Data Protection Board (EDPB)
- This document was adopted on 02 February 2021. It responds to the request from the EC for clarifications on the consistent application of the General Data Protection Regulation (GDPR), focusing on health research.