News and Notes: Contents (Updated May 29, 2020)


Inspection Updates – Domestic and International Inspections and Meetings:

Week of March 16, 2020

Most domestic and international inspections have been temporarily postponed (Canada, Europe, Japan and US). Notices have been sent out by email to affected sites, investigators, facilities and sponsors booked for an inspection.

Posted March 19, 2020

Most, if not all, in person pre-submission and pre-trial meetings have been confirmed as postponed domestically and internationally. Priority meetings and safety meetings will be scheduled virtually.



New MedDRA for COVID-19

Posted April 1, 2020

The International Council for Harmonisation (ICH) on Wednesday announced that the Medical Dictionary for Regulatory Activities (MedDRA) is being updated with new supplemental terms and corresponding codes related to coronavirus disease (COVID-19).

“The coronavirus pandemic has prompted an urgent need for a harmonised, standardised approach to coding and reporting the infection as a global health issue,” ICH says, noting that more terms are in the process of being reviewed.

The new supplemental terms are already available via the MedDRA Maintenance and Support Services Organization’s (MSSO) web-based browser, but will not become official until the release of MedDRA Version 23.1 in September. They are also posted on the ICH website under MedDRA.

The proposed supplemental terms aim to be more specific than existing terms related to COVID-19. For instance, an existing term “LLT viral test” will be replaced with a supplemental term for “PT SARS-CoV-2 test.”

ICH says it will continue to provide updates as the new terms are added.


Health Canada:

Posted May 27, 2020

Applications for drug clinical trials under the Interim Order: Guidance document

Health Canada has developed this guidance document specific to support the Interim Order Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19 (Interim Order) pursuant to subsection 30.1(1) of the Food and Drugs Act. The document provides guidance to applicants for seeking authorization of and conducting COVID-19 drug clinical trials under the new Interim Order. This is quite detailed and is a must read:


Posted May 27, 2020

Applications for medical device clinical trials under the Interim Order: Guidance document

Health Canada has created a guidance document that is intended to support applicants who wish to sell or import a COVID-19 medical device for the purposes of a clinical trial (also known as investigational testing), or to conduct a clinical trial in respect of a COVID-19 medical device, as authorized under the Interim Order Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19 (“Interim Order”).  This is an updated document:


Vaccines and Treatments for COVID-19

Posted April 23, 2020

Health Canada has created and posted a database or listing of all authorized Clinical Trials approved by Health Canada.  This listing is updated weekly. At present date there are 18 entries.  This is a separate listing from the Health Canada Clinical Trials Database.


Facilitating Clinical Trials

Posted April 23, 2020

Health Canada has reissued a notice for Companies and researchers with drugs, medical devices, or natural health products that may be effective in treating or diagnosing COVID-19 are encouraged to contact us to facilitate clinical trials.

Clinical trials are studies to find out whether a drug or medical device is safe and effective for people. We can authorize a clinical trial quickly in urgent situations.  Please contact us at:


Management of Clinical Trials during the COVID pandemic

Reposted April 24, 2020 (reminder as requested)

Health Canada issued A Notice to Clinical Trial Sponsors on the impact of the pandemic on the conduct of clinical trials, including the need for: participants to self-isolate deployment of healthcare personnel involved in clinical trials to other duties during this public health emergency. There is important site information contained in this notice.  We have reposted this notice for site review.

Posted March 24, 2020

Health Canada Guidance on Management of Clinical Trials during the COVID-19 Pandemic

Health Canada has released a Notice ‘Management of Clinical trials during the COVID-19 pandemic: Notice to sponsor. This two-page document shows the pragmatic response of Health Canada on key impacted areas. Health Canada makes concise suggestions on actions to mitigate compliance items that may need adjustment.  This is a must read article for sponsors and investigative research teams alike.

Posted March 20, 2020

Health Canada Notice regarding Medical Devices and COVID-19

On March 18, 2020, the Minister of Health approved an Interim Order Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19. The order file number for reference is 20-104980-839  The interim order will enable an expedited review of medical devices indicated to diagnose, treat, mitigate or prevent COVID-19, at no cost.

COVID-19 is a new disease not previously identified in humans. Currently there is no vaccine or therapeutic product for COVID-19 that is authorized to treat or prevent the disease. The outbreak of COVID-19 has resulted in a global review of therapies that could be used to treat or prevent the infection.

Sponsors wishing to file a submission or application should contact the appropriate review bureau.

Review Bureau Contact Information:


US Food and Drug Administration:

Posted May 14, 2020
Clinical Trial Guidance Update

The US Food and Drug Administration (FDA) has updated its guidance on conducting clinical trials on May 13, 2020.  This fourth edition for the coronavirus disease (COVID-19) pandemic addresses new questions, including:

  • the use of alternate laboratory or imaging centers,
  • video conferencing and
  • post-marketing requirements.

The update also features clarifications to questions addressed in previous versions of the guidance on managing protocol deviations and amendments and on steps sponsors should take when considering administering investigational products at home instead of at clinical trial sites. While this guidance comes from the US, it offers great practical advice to others in the same global region.

New Guidance Document

Posted week of May 11, 2020

The US Food and Drug Administration released a new Guidance this week titled ‘COVID-19: Developing Drugs and Biological Products for Treatment or Prevention.  This Guidance for Industry, has been developed quickly in response to COVID-19 pandemic, without public or stakeholder review.  It is intended to assist sponsors in the clinical development of drugs for the treatment or prevention of COVID-19. This guidance does not apply to vaccines.

Posted April 2020

Updated FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency: Guidance for Industry, Investigators, and Institutional Review Boards

In April, the US Food and Drug Administration (FDA), added seven new questions and answers to its guidance document on the conduct of Clinical Trials during the COVID-19 pandemic.  These include guidance on obtaining informed consent during the pandemic; considerations for remote clinical outcome assessments; remote site monitoring; electronic common technical document (eCTD) waivers; and other issues. Similar to the EU Commissions guidance document for conduct of clinical trials during the pandemic, this one also provides some practical suggestions.

New regulatory information on AE reporting during COVID-19 pandemic

Posted April 17, 2020

The US Food and Drug Administration revised its guidance on post-market adverse event reporting for medicinal products and dietary supplements during a pandemic to apply the guidance to the ongoing coronavirus disease pandemic.

Posted April 2, 2020

The US Food and Drug Administration (FDA) updated its guidance from from earlier in March on conducting clinical trials during the coronavirus disease (COVID-19) pandemic.

The new version, features a new appendix with ten questions and answers offering more specifics on how sponsors should manage clinical trials amid the pandemic based on questions the agency has received from sponsors so far. The remainder of the guidance is unchanged from the previous version.

Posted March 20, 2020

On March 19, 2020 The US Food and Drug Administration (FDA) revised its guidance on post-market adverse event reporting for medical products and dietary supplements during a pandemic to apply the guidance to the ongoing coronavirus disease (COVID-19) pandemic.
The guidance, applies to drugs, biologics, medical devices, combination products and supplements, outlines how the US FDA intends to prioritize adverse event reporting requirements during a pandemic.

Note for Clinical Trials BC: There has been some ‘local confusion’ about this guidance.  Please note for clarification purposes:

      • This guidance does not apply to clinical trials.
      • The revised guidance does apply to all pandemics, including COVID-19.

Posted March 18, 2020

The US FDA issued a new final guidance to help clinical trial sponsors assure the safety of trial participants, maintain compliance with good Clinical practice (GCP) and minimize the risks to trial integrity during the COVID-19 pandemic. This guidance is good reference for practice as related to trials conducted during the pandemic, and not necessarily for trials related to COVID-19 treatments.


Innovative Medicines Canada:

Posted March 23, 2020

Innovative Medicines Canada (IMC) issued the following statement in response to the federal government’s announcement of measures to aid in the rapid mobilization of large-scale efforts by Canadian researchers and life sciences companies working to combat COVID-19, including through the development of solutions to diagnose, treat and prevent the virus.

Posted March 19, 2020

IMC’s statement on Canada’s drug supply in response to this crisis. The IMC’s statement notes that there are no COVID-19 related shortages being reported, or current constraints on our member’s ability to supply innovative medicines to Canadians. IMC’s full statement on drug supply can be viewed here – IMC’s statement on Canada’s drug supply.



European Commission Guidance

Posted April 28, 2020

Guidance on the Management of Clinical Trials during the COVID-19 (coronavirus) Pandemic Version 3: 28/04/2020

The European Commission and European Medicines Agency (EMA) updated their guidance on managing clinical trials during the coronavirus disease (COVID-19) pandemic, adding advice on distribution, data verification and communicating with authorities.

This is the third update of the guidance from the Commission, EMA and the Heads of Medicines Agencies which was previously updated on 27 March 2020.  This version provides recommendations on the distribution of investigational medicinal products (IMPs) and data verification under social distancing measures and resource limitations.  The guidance also clarifies how clinical trial sponsors should communicate urgent issues to regulatory authorities.

While this guidance specific to Europe, it offers some good general advice applicable to other jurisdictions and is a recommended read.  It provides recommendations on effective mitigation related to the disruptions associated with the pandemic, to ensure that quality and safety are not compromised during the adapted conduct of clinical trials.

Update of the EMA Q&A guideline on COVID-19 regulatory expectations – medicinal products

Posted April 20, 2020

The European Medicines Agency (EMA) updated its recent question and answer guideline on regulatory expectations for medicinal products amid the coronavirus disease (COVID-19) pandemic.

Posted March 27, 2020

EMA Releases a Second Guideline Clinical Trials Methodological Aspects during a COVIC-19 pandemic

The EMA has acknowledged the impact of the Coronavirus disease (COVID-19) on trial participants and now as well as of the resulting measures taken to address the pandemic on methodological aspects of ongoing trials. This new three page guidance provides guidance on the collection, analysis and the interpretation of clinical trial data and safety. Sponsors are strongly recommended to integrate all available knowledge from the ethical, the medical, and the methodological perspective into decision making about the future conduct of a trial while carefully considering advice from regulatory and healthcare authorities responsible for patient and employee safety. Reference is made to other guidance related to the COVID-19 pandemic, including (Guidance to sponsors on how to manage clinical trials during the COVID-19 pandemic (EMA/141885/2020).

Posted March 22, 2020

New EMA Guidance Document of Management of Clinical Trials during the COVID-19 Pandemic

The European Commission, European Medicines Agency (EMA) and the Head of Medicines Agencies released guidance for biopharma companies that may need to adjust their clinical trials during the COVID-19 pandemic. This 8-page guidance is similar to the one issued by the US FDA.

It contains specific advice on measures that sponsors may want to consider, including the conversion of physical patient visits into phone or video visits, a temporary halt of a trial at some or all trial sites, the suspension or slowing down of recruitment of new trial participants, the extension of the duration of the trial, and/or the postponement of trials or activation of sites that have not yet been initiated.

The guidance also covers the COVID-19 challenges of: clinical trial monitoring, protocol deviations and administering informed consent to participants in COVID-19 trials.  It properly references The International Harmonization Council (ICH) E6R2 Good Clinical Practices and ICH E3 Clinical Study Report requirements.

EMA, in releasing this document, notes that there may be updates the guidance.

Posted March 20, 2020

This week global health authorities and the World Health Organization (WHO) held a workshop on facilitating global collaboration on vaccine development for COVID-19.

In response, The European Medicines Agency (EMA) on March 19, 2020 called on EU-based researchers to pool their resources to conduct large, multi-center, multi-arm clinical trials for potential treatments for coronavirus disease (COVID-19).

These types of studies are identified as the most likely to generate the conclusive evidence needed to enable rapid development and approval of potential treatments but small studies and compassionate use programs may also generate robust enough data to draw conclusions from.  Specifically, EMA’s Committee for Medicinal Products for Human Use (CHMP) says randomized controlled studies featuring a control arm without antivirals or other experimental therapies would provide the most reliable evidence in support of an investigational product.

The call for a coordinated approach comes as companies and researchers around the globe scramble to develop treatments and vaccines for the virus. While the virus originated in China, Europe has become the epicenter of the pandemic, with major outbreaks in Italy, Spain, France and Germany, with the death toll in Italy surpassing China’s as of March 20, 2020.

European regulatory agencies are giving priority to all requests regarding regulatory aspects in clinical trials” for products intended for COVID-19.


Research Ethics BC (REBC):

Posted March 18, 2020

Research Ethics BC has issued recommendations regarding COVID-19.


The Society for Clinical Data Management (SCDM)

Posted March 27, 2020

The SCDM has issued a statement which outlines the risk categories related to methodology and their impact on the practices of clinical data collection and management due to COVID-19.  They are also encouraging Senior Data Managers to be involved in the development of mitigation strategies in site and sponsor level risk management.


COVID-19 Risk Assessments Required

Posted April 1, 2020

The MHRA announced it has written to all sponsors conducting Phase I clinical trials to confirm they have conducted a risk assessment for the potential impact of COVID-19 on their studies.

“This action will help to ensure the safety of participants and the public, as well as avoid any adverse impacts on the capacity of [National Health Service] NHS front line services at this very challenging time.”  MHRA says it expects that some trials “may be temporarily halted or terminated,” while others may continue if “clearly justified.”

Note: Clinical Trials BC would like to clarify that that the action outlined by the MHRA does not apply to studies for potential treatments for COVID-19 for this health authority.  However, update of risk management plans is a trend and expectation in other jurisdictions at the institutional and site levels as well as sponsor level.


The International COVID-19 Trackers for Vaccines and Therapeutics

The International COVID-19 Trackers Vaccine and Therapeutics Trackers are now separated and are now being managed by Jeff Craven and team at the Regulatory Affairs Professional Society (RAPs).


Updated 28  May 2020 

The International Vaccine Tracker was updated this week to include new information on vaccine candidates from Merck, Moderna, CanSino Biologics and ImmunityBio.  Again, thank you to Jeff Craven and the RAPs team for their efforts to update this tracker this week.


Posted May 27th, 2020

This edition includes new information on remdesivir, hydroxychloroquine and EIDD-2081.  Thank you to RAPs Focus team for updating and maintaining this for the international regulatory community.


Posted May 14, 2020

The International COVID-19 Vaccine Tracker

The International COVID-19 Vaccine Tracker has been redesigned and classes Vaccines into: early development, pre-clinical, Phase I, Phase II and Phase II/III.  The Tracker now includes content on Company or Organization, candidate name or number, investigational product details, status and newly added is the clinical trials registry notation which is a very convenient addition.


Posted May 8, 2020

The International COVID-19 Therapeutics Tracker has also been redesigned and classes COVID-19 therapeutics into two categories: Frontline Therapeutics and Novel Therapeutics.  The tracker features content on: Name or Number, Class, Developer, Rationale, Regulatory action, Trials, Outcome and Status.

Both Trackers include international content from all Regions.  Clinical Trials BC will post the trackers weekly. New content is being noted at the top of the tracker as it is updated.  Any group or company with an update or content to add to the tracker can now do so by sending a note to Focus magazine to the attention Jeff Craven at the following email address:

A special Thank You to the RAPS Focus COVID-19 team for doing such a fabulous job at setting up and maintaining these two worldwide trackers on the FOCUS page and making this available to the research community during the COVID-19 pandemic.