This issue brings you the hot information from Health Canada and from the ICH:
ICH Newly-Approved Safety Guidance
The International Council for Harmonisation (ICH) on April 14, 2020, adopted its S11 guideline on nonclinical safety testing to support the development of pediatric drugs. International consensus and adoption follows 6 years of development and intensive regulatory consultations by its regulatory members and the liaison parties. The guideline, which ended up being 39 pages, lays out harmonized recommendations for nonclinical pediatric safety testing across ICH regions with the goals of:
- Promoting pediatric clinical trials and drug development
- Reducing the need for juvenile animal studies (JAS)
Special Note: Congratulations to the BC Children’s Hospital Research Institute (BCCHRI) who over the years helped with the business case for promoting the development of what became S11 at the national and international level (Dr.Anne Junker), ongoing reviews and consultation (Dr. Soren Gantt), and as well Dr.Wyeth Wasserman for his longstanding and ongoing support of the initiatives.
Health Canada Regulatory Enrolment Process
Posted: April 22, 2020
Health Canada is requesting sponsor participation in the Regulatory Enrolment Process (REP) non-functional pilot for clinical trial regulatory activities. The REP will help the clinical trial industry file their transactions to Health Canada electronically via the Common Electronic Submission Gateway (CESG) sponsors will be able to send transitions in a secure manner, with reduced transmission times and cost.
Health Canada Notice Implementation of eCTC
Posted: Feb 19, 2020
Health Canada has issued a Notice: Implementation of eCTD for clinical trial regulatory activities in electronic Common Technical Document (eCTD). Following a successful pilot programme that concluded in August 2019, health Canada has moved forward with the implementation of Clinical Trials regulatory activities in eCTD format beginning immediately for the following:
- Pre-Clinical Trial Application Consultation Meeting (PRE-CTA)
- Clinical Trial Applications (CTAs) with either a 7 day administrative or a 30 day default performance standard
- Clinical Trial Applications – Amendments (CTA-As) with a 7 day administrative or a 30 day default performance standard
- Clinical Trial Application – Notification (CTA-N)
- All related responses and post-clearance data to the regulatory activities above
The following regulatory activities and/or transactions are out-of-scope for filing in eCTD format:
- Clinical Trial Site Information (CTSI)
- Development Safety Update Report (DSUR)
- Signal assessment related requests from the Therapeutic Products Directorate/Office of Clinical Trials – Adverse Drug Reaction division (OCT ADR)
- Fax-Backs for the Biologics and Genetic Therapies Directorate
Health Canada has noted that the use of the eCTD format for Clinical Trial regulatory activities is optional. Also of note, Sponsors cannot revert back and forth between an eCTD and non-eCTD formats. So, you must select one or the other.
Health Canada Regulatory Enrolment – Clinical Trials Dossiers Pharmaceuticals
Posted: April 16, 2020
There is a New Dossier ID request form for pharmaceutical clinical trial dossiers (protocols). https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/regulatory-enrolment-process/dossier-id-request-form-pharmaceutical-clinical-trial.html
Health Canada Regulatory Enrolment – Clinical Trials Dossiers Biologics
Posted: April 16, 2020
There is a new Dossier ID request form for biologics clinical trial dossiers (protocol). https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/regulatory-enrolment-process/dossier-id-request-form-biologic-clinical-trial.html
Health Canada Vaccines and Treatments
This listing is updated weekly
Health Canada has prepared for COVID-19 a list of all authorized Clinical Trials approved by Health Canada. This is a new and separate database to the Health Canada Clinical Trials Database.
- For more information about the content on this page, please contact Jean Smart.