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Aug 3, 2020

Global Regulatory Workshop on COVID-19 Therapeutics #2: Agreement on Acceptable Endpoints for Clinical Trials
On 31 July 2020 the international regulators published a report on the acceptability of various primary endpoints in the clinical trials conducted for the development of treatments for COVID-19.

The report summarises the main outcomes of the second workshop on COVID-19 therapeutics and clinical trials organised under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA). The workshop was co-chaired by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) and EMA on 20 July 2020.

Many developers of medicines for the treatment of COVID-19 have already or are in the process of conducting clinical trials and have approached their regulatory authorities with proposals for phase 3 clinical trials.

An agreement by regulators on acceptable endpoints will facilitate rapid and consistent implementation of future clinical trials for COVID-19 medicines across the world.

For hospitalised patients with moderate to severe COVID-19, a range of suitable primary endpoints is available to measure the clinical benefits of investigational therapeutics for COVID-19 and support regulatory decision-making. While the workshop participants agreed that mortality is not the sole acceptable primary endpoint for these patients, mortality data should still be collected as a key secondary endpoint in all trials that do not plan to primarily use this outcome.

For outpatients with mild COVID-19, regulators agreed that mortality as the primary endpoint may not be suitable. Instead, the rate of progression to severe disease and the proportion of patients not hospitalised at a pre-specified time point may be more appropriate, depending on the primary objective of the study.

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MHRA Updated Guidance for the Notification of Serious Breaches of GCP or the Trial Protocol
On 31 July 2020 the UK MHRA announced the availability of the updated guidance.

The UK MHRA has updated the Notification of a Serious Breach form and associated guidance, with the aim of improving the completeness and quality of information being received by the agency for review and assessment of the breach.

The purpose of this guidance is:

  • To outline the practical arrangements for notification.
  • To provide advice on what should and what should not be classified as a “serious breach” and what must be reported.
  • To outline possible actions that may be taken by the MHRA in response to notifications of serious breaches.

Read the pdf 

Multiple Function Device Products: Policy and Considerations
On 29 July 2020 the FDA issued the final guidance for industry and FDA staff.

Medical products may contain several functions, some of which are subject to FDA's regulatory oversight as medical devices, while others are not. Products with at least one device function and at least one "other function" are referred to in this guidance as "multiple function device products." For purposes of this guidance, for any given product, the term "function" is a distinct purpose of the product, which could be the intended use or a subset of the intended use of the product. This guidance explains FDA's regulatory approach and policy for all multiple function device products. Specifically, this guidance clarifies when and how FDA intends to assess the impact of "other functions" that are not the subject of a premarket review on the safety and effectiveness of a device function that is subject to FDA review. The purpose of this guidance is to identify the principles, premarket review practices, and policies for FDA's regulatory assessment of such products, and to provide examples of the application of these policies.

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Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products
On 29 July 2020 the FDA issued the final guidance for industry.

The last few decades have seen an increasing demand in various health care settings for solid oral dosage form drug products repackaged into unit-dose containers, which hold a quantity of drug for administration as a single dose. The increase in unit-dose repackaging has led to questions regarding stability studies and appropriate expiration dates for these repackaged products. This guidance describes the circumstances under which FDA generally does not intend to take action regarding required stability studies for these repackaged products and appropriate expiration dates under those circumstances.

This guidance addresses repackaging of prescription and over-the-counter solid oral dosage form drugs into unit-dose containers by commercial pharmaceutical repackaging firms that are required to register with FDA under section 510 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and to comply with current good manufacturing practice (CGMP) regulations in 21 CFR parts 210 and 211.

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EMA Updated the GCP Q&A
On 24 July 2020 the EMA updated the GCP Q&A.

The EMA has added a new Q&A (#13) regarding requirements for Principal Investigator (PI) review and sign-off of data.

The investigators are responsible for data entered into eCRFs and other data collection tools under their supervision (electronic records). Those data should be reviewed and signed-off.

It is important that the PI reviews the data on an ongoing basis in order to detect shortcomings and deficiencies in the trial conduct at an early stage, which is the precondition to undertake appropriate corrective and preventive actions.

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MHRA Planning for Return to On-site Good Practice (GxP) Inspections
On 23 July 2020 it was published on the MHRA Inspectorate Blog that MHRA is planning for return to on-site GxP inspections.

During the past few weeks, the MHRA inspectors have been engaging with industry trade associations and the NHS to discuss the practical arrangements that may be required to facilitate on-site inspections starting in September and scaling up to a full programme beginning October 2020.

Inspection conduct will vary according to the requirements of each GxP area and may include a hybrid model of on- and off-site activities that support a single inspection cycle.

Further information will be made available later in the summer. Organisations receiving notice of inspection are encouraged to discuss arrangements for personal protective equipment, social distancing, engagement with personnel and access to facilities and information at the earliest opportunity.

Until the full programme resumes, MHRA will continue to conduct its current COVID19 programme of remote assessment. Consistent with previous guidance, on-site inspections linked to the UK Government’s COVID19 response or any other potential serious public health risk, and where remote assessment is not possible, will continue until September as normal programmes resume.

There are currently no plans for a return to international inspections, where we continue to rely on remote assessment procedures and our communication with the international regulatory network. Further information on international inspections will be provided as the situation develops.

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EMA Updated EudraVigilance Registration Manual
On 21 July 2020 the EMA announced the availability of the updated EudraVigilance registration manual.

Update Note: The EudraVigilance XCOMP (Test system) has been aligned with Production.

To set-up a new organisation in EudraVigilance Production or XCOMP (Test system), a series of steps need to be followed:

1. A person within the organisation needs to be chosen as being responsible for managing the organisation and its users in the EudraVigilance Production system. If the organisation is a marketing authorisation holder, the primary responsible person will be a Qualified Person for Pharmacovigilance (QPPV).

2. Register for an EMA user account in the EMA Account Management portal if you do not already have one – see section 2: User registration with EMA Account Management portal (IAM).

3. Check the Organisation Management System (OMS). If your organisation is not present in the OMS it will need to be registered – see section 4: Create a new Organisation.

4. Submit request to be registered as the responsible person for the organisation – see section 3.2: EU QPPV or Responsible Person access request.

5. Complete organisation registration details in the EudraVigilance restricted area – see section 4.1: Finalise organisation information in EV Human Production and XCOMP.

6. The EMA confirms separately to the organisation that their Webtrader or Gateway transmission mode has been set up – see section 6: Webtrader and Gateway transmission.

Once the QPPV or responsible person is registered for the Production EudraVigilance system, they will automatically be registered for an XCOMP test account for the same organisation.

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Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use
On 21 July 2020 the FDA announced the availability of the final guidance for industry and FDA staff.

The guidance does not alter FDA's current thinking on the regulatory criteria of minimal manipulation and homologous use for human cells, tissues, and cellular and tissue-based product (HCT/P).

The guidance announced in this notice supersedes the guidance of the same title dated November 2017 and corrected December 2017. The guidance revises section V of the November 2017 guidance to communicate that the Agency is extending the period of time during which FDA intends to exercise enforcement discretion regarding certain regulatory requirements for certain HCT/Ps; this time period will run through May 31, 2021, instead of November 30, 2020.

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