Clinical Trial Regulations Q4

Clinical Trials News and Regulations

As we reach the end of 2020, we release our final Industry Update of the year, compiled by Christina Hägglund, QA Manager, S-cubed Ltd. This quarter, we cover the latest COVID-19 Guidance and BREXIT news.

You can download a pdf of this update here and sign up to receive our updates via email here.

COVID-19 Guidance

Europe and World




BREXIT Guidance Documents (for the end of the Transition Period, 31 Dec 2020). Also see the information provided in our previous articles

MHRA Joins the Access Consortium

The Australia, Canada, Singapore and Switzerland (ACSS) Consortium of regulators will become the Access Consortium, when the MHRA joins on 01 January 2021. The combined population of participating countries will then be approximately 145 million.
The countries in the consortium work together to reduce regulatory duplication in order to give patients timely access to high quality, safe and effective therapeutics.

Regulations & Guidance

EU Clinical Trial Regulation (CTR)

The CTR becomes applicable 6 months after the EC confirms the full functionality of the Clinical Trial Information System (CTIS) following an independent audit. The CTIS will be the single entry point for submitting clinical trial information in the EU, and information stored in the CTIS will be made publicly available subject to transparency rules.
The EMA management board has confirmed that the CTIS audit began in November 2020.

Revision of Good Clinical Practice guideline (ICH E6(R3))

On the 03 June 2020, a virtual half-day workshop was held, aimed at gathering the views of European patients, healthcare professionals and clinical researchers on clinical trials and applying GCP.

Paediatric and Orphan Drug Regulatory Framework

The EC has published its evaluation of the paediatric and orphan drug regulations.

Trial Management

Real World Evidence (RWE) & Big Data

MHRA Consults on Trials Generating RWE to Support Regulatory Decisions

The consultation period for this new draft guidance has now ended and is the first in a planned series of documents that will address issues related to the use of RWE to support regulatory submissions.

Global Collaboration on COVID-19 RWE

On 13 October 2020, medicines regulators from around the world took part in a workshop to discuss their experiences of using RWE to facilitate regulatory decision making on COVID-19 treatments and vaccines.

EMA Releases Plans on the Use of Big Data for Public Health

Big data are extremely large, rapidly accumulating datasets captured from for example electronic health records. It can complement the evidence from clinical trials and fill knowledge gaps on a medicine, and help to better characterise diseases, treatments and the performance of medicines in individual healthcare systems.
The Big Data Steering Group (set up by the EMA and the Heads of Medicines Agencies) has published its workplan for 2020–2021.

Registration and Transparency

EMA Implements Extra Transparency for COVID-19 Vaccines and Therapeutics

During the pandemic, the EMA is implementing exceptional measures to maximise the transparency of its regulatory activities on treatments and vaccines for COVID-19 that are approved or under evaluation.

UK’s HRA Launch ‘Make it Public’ Strategy

When applying for HRA approval, applicants currently have to describe their dissemination plans, including whether they plan to inform participants about the study findings.
In the future, the HRA will ask applicants:

  • How and when will study results be shared with participants
  • To submit a lay summary of the study results as part of the final report (which the HRA will publish on its website).

HRA will produce new guidance on how to inform participants about study findings, including research involving adults without capacity, emergency research and research in which participants are likely to die from their existing illness.

FDA and Penalties

US legislation allows the FDA to seek financial penalties from developers of drugs, biological products and devices who fail to submit clinical trial registration and/or results to the database, or who submit false or misleading information.
The FDA has issued a guidance document on the penalties.

Publication of Clinical Trial Results – Danish Regulators

A 2019 survey found that only 24% of non-commercial sponsors in Denmark fulfil their obligation to publish the results of clinical trials of medicines.
Legislation in Denmark allows the public prosecutor to impose fines or up to 4 months’ imprisonment on sponsors who fail to publish their clinical trial results in a timely manner. The agency intends to use this legal power in the future.

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