Clinical Development Practices and Regulations are the main focus for our Q2 Industry Update. We also include important information about COVID-19, expertly compiled by Christina Hägglund, QA Manager, S-cubed Ltd. Read all the latest regulatory news here.

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COVID-19 GUIDANCE

Below are some of the key guidance documents that have been released relating to the Covid-19 pandemic – it is not an exhaustive list.

Europe

UK

USA

REGULATIONS AND GUIDANCE

Clinical Trial Regulation (CTR) EU No 536/2014

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. Full details here.

Regulatory Science to 2025

‘Regulatory Science to 2025’ is a new strategy, adopted by the European Medicines Agency (EMA). The strategy reflects feedback from an extensive consultation involving a wide range of stakeholders. The strategy aims to build a more adaptive regulatory system that will encourage innovation in medicines development.

Medical Device Regulation (EU) 2017/745

This Regulation entered into force 25 May 2017 and should have been fully applicable in all EU Member States a year later. This has now been extended for a year to May 2021.

ICH E8(R1) ‘General Considerations for Clinical Trials’

ICH held a public meeting in October 2019 and issued a report in February 2020 to summarise the meeting. Comments from the meeting will be considered by the ICH E8(R1) working group.

Brexit and Regulations

Following Brexit, the UK has entered a transition period which lasts until the end of 2020. During this period the current EU rules for medicinal products apply. A new Notice from the EC and the EMA explains the steps that need to be taken by marketing authorisation holders before the end of the transition period in order to ensure ongoing compliance to regulations. The notice covers pharmacovigilance, orphan drugs and inspection findings.

A Post-Brexit Medicines and Device Bill has been referred to a Public Bill Committee. The Committee has been appointed but the sittings have been postponed. It is proposed that when it reconvenes it should report by Thursday 11 June 2020.

New FDA Guidance on Regulatory Submissions in Electronic Format

On 21 February 2020, the Food and Drug Administration (FDA) revised its guidance on making regulatory submissions using the electronic common technical document (eCTD) format in cases where an exemption or waiver from the eCTD requirements is warranted.

New FDA Final Rule to Revise Definition of Biological Product

The final rule came into effect 23 March 2020. The change comes in advance of the transition of approximately 100 products approved under new drug applications to biologics licence applications.

Notice to Sponsors on the Validation and Qualification of Computerised Systems used in Clinical Trials

On 7 April, EMA released the above notice in relation to validation and qualification of computerised systems in clinical trials. 

PUBLISHING TRIAL RESULTS

Sponsors are Failing to Report Trial Results

The World Health Organization (WHO) advocates full transparency of ongoing clinical trials and compliance with the WHO Joint Statement on disclosure of results.

In the EU, sponsors are required to post summary results to the trials registry within 12 months of completion. In July 2019 the EMA co-authored a joint open letter to all clinical trial sponsors, reminding them of their obligation to publish the results of clinical trials in EudraCT.

  • Recent surveys indicate less than one-quarter of non-commercial sponsors in Denmark have published trial results, with similar outcomes from other Scandinavian countries and Austria.

The FDA Amendments Act (FDAAA) of 2007 requires sponsors of applicable clinical trials to report their results on ClinicalTrials.gov within 1 year of trial completion.

  • Fewer than 41% of clinical trials had their results reported on ClinicalTrials.gov within 1 year of completion (according to a cohort study conducted by researchers at the University of Oxford and published in The Lancet).

When clinical trials are conducted but the results are not made publicly available, there is potential for the evidence base for clinical practice to be distorted. Effectively, healthcare professionals and patients are making decisions without all the information. There are also ethical concerns over the involvement of participants in research that is not subsequently published.

Below are the reports from various sources:

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