With COVID-19 dominating clinical trials news, our latest industry update includes coverage of the key guidance documents issued by the regulators and much more. Compiled by Christina Hägglund, QA Manager, S-cubed Ltd.
COVID-19 Guidance for Clinical Trials
Some of the key guidance documents (not an exhaustive list) relating to the pandemic.
- Statements from the International Coalition of Medicines Regulatory Authorities (ICMRA)
- EMA: Regulators to Focus on Alignment and Flexibility
- EMA: International Coordination for Large Decision-Relevant Trials
- EMA: Regulators to Cooperate on Covid-19 Observational Research
- EMA: Methodological Aspects of Ongoing Clinical Trials
- EMA: Individual Safety Case Reporting
- EMA: Real-World Monitoring of Treatments and Vaccines
- EMA: European Medicines Agency (EMA) Development Support
- NIH: National Institute of Health Launches National COVID Cohort Collaborative (N3C)
- FDA: Conduct of Clinical Trials, including Informed Consent and Video Conference
- FDA: Statistical Considerations
- FDA: Bringing Coronavirus Vaccines to the Market
- FDA: Post-Marketing Safety Reporting
Regulations and Guidance
Summary of ICH Assembly Virtual Meeting
The meeting included updates on the working groups’ progress. ICH E8 ‘General Consideration for Clinical Trials’ is being updated to R1. The revision proposal focuses on data quality, including the concept of quality by design (QbD) as a key consideration in the study planning phases, which implies designing quality into the study protocol, procedures and associated operational plans.
E6(R2) ‘Good Clinical Practice’ A complete rewrite, to E6(R3) is expected middle of 2022. The main goal is to provide updated guidance which is flexible enough to address the increasing diversity of clinical trial designs and data sources currently employed to support regulatory decisions.
- ICH E8(R1) dated May 19: GENERAL CONSIDERATIONS FOR CLINICAL STUDIES E8(R1)
- ICH E6(R3) Concept Paper, dated Nov 19: Guideline for Good Clinical Practice
Clinical Trial Regulation (CTR) EU No 536/2014
Medical Device Regulation Guide
This is a free global guidance tool launched by Oxford researchers to help medical device innovators.
FDA Publishes New Proposed Rule on Reporting Requirements
Currently, sponsors/manufacturers can, under the Right to Try Act (2017) provide unapproved treatments to eligible patients. Once the proposed rule is finalised, sponsors/manufacturers need to provide the FDA with an annual summary for any eligible investigational drug. Read the FDA news release here.
The FDA has transitioned the Purple Book to a searchable, online database that contains information about biological products, including biosimilar and interchangeable biological products, licensed (approved) by the FDA under the Public Health Service (PHS) Act.
FDA Guidance – Providing Regulatory Submission for Medical Devices in Electronic Format
This document was issued on 15 July 2020. Read full details here.
Compliance with Post-Brexit Clinical Trial Rules
The EC, the EMA and the Heads of Medicines Agencies have released a joint statement reminding Sponsors that they must be in compliance with the applicable rules before 31 December 2020 (the end of the transition period), including:
- Qualified Person (QP) must be established in the EU or European Economic Area (EEA).
- Sponsor or legal representative must be established in the EU/EEA
The EC has also published a ‘Brexit Readiness Checklist’. This checklist is designed to help EU companies doing business in the UK and/or UK companies doing business in the EU.
MHRA Post-Transition Period Information
MHRA New Business Plan 2020 to 2021
The Agency is driving forward a substantial strategic and cultural change through 2020-21. Read full details here.
MHRA Updates Notification Requirements
When the MHRA has queries relating to Serious Breaches, the queries are usually for missing information and/or justification for the decisions made. The MHRA has updated the guidance and form with the aim of directing the reporting organisation to provide all the required information.
MHRA Annual Metrics Report April 2018 to March 2019
EMA new Guideline for PV Inspection Follow-up
The guideline came into effect on 01 May 2020 and defines the steps in the follow-up of pharmacovigilance inspections in the EU and the responsibilities of the various parties involved.
MHRA Annual Metrics Report April 2018 to March 2019
MHRA Patient Support Programmes
A Patient Support Programme can be defined as an organised system where a Marketing Authorisation Holder (MAH) receives and collects information relating to the use of its medicinal products. The MHRA is often asked by industry about the expectations for the collection of safety data from these programmes. Further information is available on the MHRA inspectorate blog.
EMA Announces Waiver of Fees
Academia plays a vital role in the development of innovative medicines and scientific methods. The EMA has announced the waiver of fees for scientific advice for the academic sector.
Questions over EU Orphan Drug Legislation
The British Medical Journal (BMJ) has published a critical article on the EU’s orphan drug legislation. The EC has acknowledged certain flaws in the current legislation and is seeking ways to improve.
New Antimicrobial Resistance (AMR) Fund
This is a new industry fund to tackle antimicrobial resistance and was launched 10 July 2020. The aim is to have two to four new antibiotics on the market by 2030.
EMA Assesses Validation and Qualification of Computerised Systems
A new Notice for sponsors has been issued to highlight how inadequate validation and/or qualification of computerised clinical trial systems can impact on the integrity of clinical trial data.