2024-02-28 21:30:00
December 21, 2023
Revised: February 27, 2024
Our file number: 24-100744 – 309
Health Canada, as an official member of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), is committed to adopting and implementing the ICH guidelines. Health Canada is pleased to announce the implementation of the ICH E19 guideline: “Selective Approach to the Collection of Safety Data in Specific Late-Phase Pre-Authorization or Post-Authorization Clinical Trials.”
This guide was developed by a group of ICH experts and was subject to consultation. It should be read in conjunction with this notice. This guidance is available on the ICH website. Please note that the ICH website is only available in English. If you would like to obtain a version of the document in French, please contact [email protected]
Selective safety data collection refers to the recording of certain data by researchers in case report forms. It does not affect the monitoring and clinical care of trial participants or the documentation of their adverse effects in medical records. It also does not impact regulatory safety reporting requirements. Therefore, the safety reporting requirements set out in the Food and Drug Regulations must still be respected.
Eligible clinical trials
To be considered for selective collection of safety data, trials must meet all of the following criteria:
Phase IV trial or late phase trial of a drug whose use exceeds the conditions of use for which the drug has received marketing authorization or in rare cases, phase III trial of a drug which has not yet received marketing authorization. For example: Clinical trials supporting a new indication for an authorized drug when the two populations are similar (e.g., with respect to demographics, comorbidities, concomitant therapies), or when the population of Patients in the new indication were well represented in trials that supported the approved indication. Clinical trials designed to expand the information on the label of an authorized drug by adding additional endpoints within the same patient population. Safety trials aimed at investigating potential safety issues by focusing on specific endpoints. Clinical trials intended to provide additional evidence of effectiveness. The trial is not looking at gene therapy or a rare disease. The safety profile of the drug is well understood and documented.
Information to be provided by promoters
The protocol must clearly describe the following:
What data will not be collected or will be collected at a reduced frequency? How will selective collection of safety data be implemented (e.g. for all participants, for a subset of participants, after an initial period of the trial, etc.)
The clinical trial application must provide sufficient evidence to support the conclusion that the safety profile of the drug has been sufficiently characterized to warrant selective collection of safety data.
Interim approach to enforcement
ICH Guideline E19 has already been implemented in other jurisdictions around the world. To continue to attract clinical trials that provide Canadians with access to new treatments, Health Canada will not prioritize enforcement of the requirement for sponsors to keep records of all adverse events when The authorized protocol describes a selective approach to collecting safety data that meets eligibility criteria. For eligible clinical trials, medical records may be audited if an inspection occurs to ensure that the selective safety data collection protocol is followed. This will be in effect until changes are made to the Food and Drug Regulations and the Regulations respecting clinical trials of medical devices and drugs related to COVID-19. Health Canada reserves the right to apply the Food and Drugs Act and its implementing regulations if real or potential health and safety risks are identified.
Contact details
If you have any comments or requests for information regarding this notice, please contact:
Health Canada — ICH Coordinator
Email: [email protected]
Please indicate “Implementation of ICH E19” in the subject line.
1709253254
#Advisory #Implementation #ICH #E19 #selective #approach #collecting #safety #data #specific #latestage #preauthorization #postauthorization #clinical #trials