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.

You can download the pdf of this update here and you can sign up to receive these updates via email.

COVID-19 Guidance for Clinical Trials

Some of the key guidance documents (not an exhaustive list) relating to the pandemic.

Global:

Europe:

USA:

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.

Clinical Trial Regulation (CTR) EU No 536/2014

The draft Q&A document has been updated. This document will enter into force at the same time as the Regulation. Timeline – an independent audit will confirm the full functionality of the Clinical Trial Information System (CTIS). After the audit, the European Commission (EC) will publish a notice of confirmation and the CTR will become applicable 6 months after the publication.

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.

FDA Completes the Transition to an Online Purple Book

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. 

BREXIT

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

Guidance for industry and organisations to follow from 1 January 2021.

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.

Serious Breaches

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

Full report here.

Pharmacovigilance (PV)

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

Full report here.

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.

Orphan Drugs

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.

Miscellaneous

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.

If you require support or advice with any issues raised by the this latest industry update, please contact us here.