Medicines and Healthcare products Regulatory Agency (MHRA)

Updated guidance on Clinical Trial Applications for Coronavirus (COVID19)

On 5th October 2020, the MHRA added new information to the guidelines on Clinical Trial Applications for Coronavirus (COVID-19). Key points are the following:

  • Prioritising COVID-19 assessments. The MHRA has implemented procedures for rapid scientific advice, reviews and approvals and are ready to support manufacturers, researchers, and other regulators. The authority has dedicated resources to ensure this happens and have been able to approve initial applications in an average time of 9 days. In addition to their usual scientific advice services, they are also able to arrange an informal 1-hour regulatory advice meeting to discuss any aspect of the clinical trial.
  • COVID-19 applications should be submitted directly to the Clinical Trial Helpline by emailing clintrialhelpline@mhra.gov.uk, as well as through the normal Common European Submission Portalroute so work  can be started as soon as possible. They will then liaise closely with any applicants to ensure it’s managed as efficiently as possible. For clinical trials for treatment or prevention of COVID-19 the MHRA is also able to provide an optional pre-assessment service. This allows 2-way continuous communication directly between the MHRA assessors and the trial Sponsor with direct feedback on a rolling review basis for any trial documentation. This can be prior to the formal submission.
  • As requested by the World Health Organization (WHO), the Sponsor should ensure that the WHO official acronym for the coronavirus disease (COVID-19) is entered in the title field of the trial registration data set (Annex 1 XML). This will facilitate finding and extracting clinical trials related to COVID-19 from public databases.

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New guidelines on registration of clinical trials for investigational medicinal products and publication of summary results from 1st January 2021

In the UK, any favourable opinion given by a research ethics committee is subject to the condition that the clinical trial is registered on a publicly accessible database. Registration should occur before the first participant is recruited and no later than six weeks after recruitment of the first participant.

From 1st January 2021, existing and established international registers such as ISRCTN (International Standard Randomised Controlled Trials Number) registry (UK), or ClinicalTrials.gov (USA) should be used to ensure the public awareness of a trial. For trials involving both UK and EU sites a record in the EU Clinical Trials Register will exist (other than adult Phase 1 studies).

The link to where the study is registered should be included in the Integrated Research Application System (IRAS) when the application is prepared. If a sponsor wishes to request a deferral of study registration within the required timeframe, in accordance with current transparency rules (e.g. due to commercial sensitivity), they should contact the Health Research Authority (HRA) at study.registration@hra.nhs.uk.

The UK will continue to make information about trials being conducted in the UK available to the public, patients, researchers and clinicians via the HRA research summaries website and UK “Be Part of Research” website.

The time frame for publishing the summary of the trial results is within 6 months of the end of trial for paediatric clinical trials or within one year of the end of trial for non-paediatric clinical trials. Sponsors must send a short confirmatory email to CT.Submission@mhra.gov.uk once the result-related information has been uploaded to the public register and provide a link. Summary results from studies exempt from public registration should be submitted to the MHRA. Sponsors should also submit a final report to the Health Research Authority within the same timeframe for reporting the summary of results.

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New guidelines on procedures for UK Paediatric Investigation Plan (PIPs) from 1st January 2021

On 1st September 2020 MHRA published new procedures for UK PIPs effective from 1st January 2021.

The MHRA is simplifying their PIP application process for applicants by offering an expedited assessment where possible, and by mirroring the submission format and terminology of the EU-PIP system. Therefore, the scientific content and assessment required will be kept in line with European Medicines Agency (EMA) guidance documents.

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New guidelines on substantial amendment to a clinical trial from 1st January 2021

On 1st September 2020 the MHRA published new guidelines on substantial amendments to a clinical trial. This guidance covers topics including changes to the trial sponsor/legal representative, investigational medicinal product certification and importation and amendments to the Research Ethics Committee.

The UK will require the sponsor or legal representative of a clinical trial to be based in the UK or country on an approved country list which would initially include EU/European Economic Area (EEA) countries.

As is the case today, a substantial amendment will be required to be submitted to the MHRA to change (add/replace) any IMP manufacturing, importation or certification site relevant for supply of IMP to an ongoing UK trial. If the sponsor chooses to retain an existing UK IMP release site but includes an additional EU/EEA site for trials in the EU/EEA only, then no substantial amendment will be required. The IMP supply chain from a country on the approved list will allow direct supply to clinical investigator sites.

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New guidelines on regulating medical devices from 1st January 2021

From 1st January 2021 the MHRA will take on responsibilities for the UK medical devices market currently undertaken through the EU system. This guidance provides information on how the UK system will operate, including for:

  • Getting a device certified
  • Conformity marking a device
  • Registering a device with the MHRA

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New guidelines on pharmacovigilance became effective from 1st January 2021

This guidance summarises the MHRA approach to pharmacovigilance from 1st January 2021.

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MHRA – Joins Australia-Canada-Singapore-Switzerland (ACSS) Consortium

On 2nd October 2020, the MHRA joined the ACSS Consortium. To accommodate the MHRA joining, the group will now be known as the Access Consortium. The aim of the group is to provide patients with timely access to high quality, safe and effective therapeutic products across the five countries. This is accomplished by Access partners working together, aligned by high standards of scientific rigour and integrity, with reduced regulatory duplication.

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European Medicines Agency (EMA)

COVID-19 Updates

EMA’s governance during COVID-19 pandemic:

On 5th October 2020 the EMA announced the establishment of a dedicated task force to deal with the scientific, regulatory and operational challenges created by the COVID-19 pandemic and initiated its business continuity plan. The aim of these measures is to safeguard the Agency’s core activities related to the evaluation and supervision of medicines during the pandemic and to ringfence resources dealing with COVID-19. The governance will include:

  • COVID-19 EMA pandemic Task Force
  • EMA COVID-19 Steering Group
  • EMA health threats plan
  • Business continuity plan for the European medicines regulatory network

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On 10th September 2020, the EMA released their European Medicines Regulatory Network (EMRN) COVID-19 Business Continuity Plan (BCP). The document has been developed to address the consequences of the COVID-19 pandemic on the regulatory activities performed by the Regulatory Authorities of the ERMN an European Medicines Regulatory Network COVID-19 Business Continuity Plan (EMRN COVID-19 BCP). The EMRN COVID-19 BCP will be subject to regular review and revisions, when needed.

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On 1st October 2020 the EMA’s human medicines committee has started the first rolling review of a COVID-19 vaccine. It is being develop by the company Astra Zeneca in collaboration with Oxford University.

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On 6th October 2020, the EMA’s human medicines committee has started the rolling review of a second COVID-19 vaccine. The vaccine is being developed by BioNTech in collaboration with Pfizer.

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Recommendations on paediatric clinical trials.

On 1st September 2020, the European Network of Paediatric Research at the EMA (Enpr-EMA) published recommendations on how to enable the smooth and timely conduct of clinical trials in children. The recommendations cover areas such as collection of relevant data or ways to involve clinical-trial sites, expert groups, patients and regulators in the preparation of studies.

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In September 2020, the EMA announced its plan to provide early access to Clinical Trials Information System (CTIS)

On 21st September 2020, the EMA announced its plan to provide access to a test version of the CTIS by mid-2021. The CTIS is a portal relating to the Clinical Trials Regulation (Regulation (EU) No 536/2014) and it is anticipated to enter into application soon. Potential users will have access to an isolated and secured testing environment, called the sandbox, with the intention of encouraging potential users to familiarize themselves with the system before it goes live in December 2021. Elements of the system include guidance from the EMA on how to access the system and how to submit a clinical trial application. The EMA highlighted that preparation by users before using the test version is essential.

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Independent Scientific experts: Call for expressions of interest for the EMA PRAC Committee

The European Commission is launching a selection procedure to appoint the Independent Scientific Experts to the Pharmacovigilance Risk Assessment Committee (PRAC) of the EMA. Six Independent scientific experts will be appointed. The successful candidates will be appointed for a three-year-mandate starting on 2nd July 2021.

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Food and Drug Administration (FDA)

Guideline on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency updated

On 21st September 2020, the FDA updated the guideline with new questions answered. Specifically, the following questions have been addressed by the FDA in the update:

  • Reporting of serious adverse event associated with COVID-19 during the trial
  • Using of the electronic systems to generate electronic signatures on clinical trial records, including informed consent documents, during the COVID-19 public health emergencyinstituting trial participant visits remotely through video conferencing.

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Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program

The new guideline on ASCA was released on 25th September 2020. The ASCA Pilot is part of the enactment of the Medical Device User Fee Amendments of 2017 in which the FDA was directed to issue a guidance regarding the goals and implementation of the ASCA Pilot. The FDA believes the voluntary ASCA Pilot may further encourage international harmonization of medical device regulation because it incorporates elements from a number of practices and standards (e.g., ISO/IEC 17000 series). The voluntary ASCA Pilot does not supplant or alter any other existing statutory or regulatory requirements governing the decision-making process for premarket submissions.

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The FDA issued new guidelines Biocompatibility Testing of Medical Devices – Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program.

This guidance published on 25th September 2020 provides information on how the Biological Evaluation of Medical Devices standards are incorporated into the Pilot Accreditation Scheme for Conformity Assessment Program. The ASCA Pilot is described above.

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Importation of Certain FDA – Approved Human Prescription Drugs, Including Biological Products, and Combination Products

The October 2020 guidance describes recommended procedures to obtain a National Drug Code for certain FDA-approved prescription drug products that are imported into the United States. The guidance specifically addresses FDA-approved drugs that are also authorised for sale in a foreign country in which the drugs were originally intended to be marketed.

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An Abbreviated New Drug Application (ANDA) Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs

The September 2020 guidance is intended to assist applicants in preparing and submitting amendments to tentatively approved ANDAs, including requests for final approval. The guidance provides recommendations on the timing and content of amendments to facilitate submission in a timely fashion to enable final approval on the earliest date.

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FDA Approved First Treatment for COVID-19

On 23rd October 2020, the FDA approved the antiviral drug Veklury (remdesivir) for use in adult and paediatric patients for the treatment of COVID-19 requiring hospitalization. Veklury should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care. Veklury is the first treatment for COVID-19 to receive FDA approval. The approval of Veklury was supported by the agency’s analysis of data from three randomised, controlled clinical trials that included patients hospitalised with mild-to-severe COVID-19.

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European Commission (EC)

Memorandum of Understanding (MoU) on regulatory flexibility for COVID-19 vaccines

In the context of the recently adopted EU Vaccine Strategy, in particular its Regulatory Pillar, the Commission presented a draft MoU among Member States on labelling and packaging flexibilities for authorized COVID-19 vaccines in order to facilitate more rapid deployment of these vaccines.

The document was subsequently shared with the Heads of Medicines Agencies for consultation and then endorsed by the EU Executive Steering Group on 26th August 2020. A written consultation followed with the Pharmaceutical Committee ending on 8th September 2020. No specific comments were received, and no further concerns were raised in the subsequent meeting of the Pharmaceutical Committee on the 18th of September; therefore, the document was accepted.

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Issue Number: RN2710

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