Public release of clinical information for drugs and medical devices in COVID-19 interim orders applications: Guidance

On this page

• Policy objective
• Scope and application
• Publication process
• Terminology and definitions

Policy objective

This guidance is to provide Canadians with access to information on the safety and efficacy/effectiveness of products being used for the COVID-19 pandemic. These products are being imported and sold in Canada under 2 interim orders:

• Interim order respecting the importation, sale and advertising of drugs for use in relation to COVID-19
• Interim order No. 3 respecting the importation and sale of medical devices for use in relation to COVID-19

All personal and confidential business information (CBI) will be protected prior to release. The disclosed information will be made publicly available for non-commercial purposes after Health Canada completes its regulatory review process, while adhering to Canada’s Privacy Act.

Providing public access to this information supports Canada’s objective for transparent decision-making. Public access also provides valuable information that may help with the use or development of COVID19 drugs and medical devices.

This guidance document outlines the process for publicly disclosing information in a market authorization application under the 2 interim orders. The process includes:

• procedures when releasing information
• types of information that fall under the guidelines for CBI and that may be eligible for redaction
• protection of personal information

Scope and application

This document applies to information relied upon to issue a market authorization under the:

• interim order respecting the importation, sale and advertising of drugs for use in relation to COVID-19 (September 16, 2020) and
• interim orders respecting the importation and sale of medical devices for use in relation to COVID-19 (beginning on March 18, 2020)

The public release of safety and efficacy/effectiveness information reviewed under the 2 interim orders is governed by common law. Information requested for release is assessed case by case to determine what is CBI. Personal information is removed before the safety and efficacy/effectiveness information is released to the public.

Following Health Canada’s review of an application, safety and efficacy information will be released as follows:

• automatically disclosed in applications submitted under the interim order for importing, selling and advertising drugs (proactive release)
• disclosed on request in applications submitted under the interim order for importing and selling medical devices (released upon request)

Information in applications that have been authorized, including those authorized and then revoked, is in scope for public release. This includes:

• original application documents
• documents filed after market authorization is issued (filed at Health Canada’s request or to meet a condition of approval)

Information in applications that are refused and were never authorized is out of scope for public release.

This document does not apply to clinical information submitted to support the market authorization of a medical device under the Medical Device Regulations or of a new drug submission under the Food and Drug Regulations (FDR). The exception are new drug submissions for COVID-19 indications submitted under the FDR. For more information on the public release of this information, see the Public Release of Clinical Information: guidance document.

Also not applicable under this document is the CBI disclosure authority under section 21.1(3)(c) of the Food and Drugs Act. This section permits the Minister of Health to disclose CBI to certain persons for the purpose of protection or promotion of human health or the safety of the public. For information on this authority, see the guidance document Disclosure of Confidential Business Information under Paragraph 21.1(3)(c) of the Food and Drugs Act.

Proactive release of drug application information

We will proactively publish safety and efficacy information used to support interim order drug applications upon authorization. This includes clinical information in applications submitted under sections 3, 6 and 14 of the interim order.

How to request clinical information in medical device applications

We will publish safety and effectiveness information used to support interim order medical device applications when we receive a request from the public and within the limits of our administrative capacity. Requests made for multiple applications will be processed in sequence and subject to prioritization. Further prioritization may be given to products that have a greater impact on the health system, such as:

• products that are used a lot
• products that have a higher public interest

Requests received for information in applications under the interim order will be prioritized over requests for clinical information in non-COVID19-related drugs submissions and device applications.

To request clinical information on medical device applications, use our special portal to submit an electronic request form. Be sure to identify the product name listed on the following sites:

• medical devices for use against coronavirus (COVID-19): List of products authorized under interim order
• diagnostic devices for use against coronavirus (COVID-19): List of authorized devices

Publication process

Publication of safety and efficacy information used to support drug interim order applications

The publication of information follows the process described in section 4 and Appendix C of the Public Release of Clinical Information guidance document.

In accordance with PRCI timelines, we aim to publish a final redacted and anonymized package on our clinical information portal within 120 calendar days from starting the process. The process starts automatically on the day an authorization is issued.

Step 1: Notice to the company and request for proposed CBI redactions and anonymization

Following the authorization of a drug under the interim order, Health Canada will give the manufacturer an opportunity to take part in a process initiation meeting.

The first 60 days of the 120-day publication process is allocated for the company to review the clinical information. The company uses the Proposed Redaction Control Sheet (Appendix E, Public Release of Clinical Information (PRCI) guidance document) to propose any redaction of CBI. Proposed CBI redactions should pertain to information that meets the definition of confidential business information. This is defined in Section 2 of the Food and Drugs Act, which mirrors common law in the context of confidential business information that meets each of the following 3 elements of the definition:

• that is not publicly available
• in respect of which the person has taken measures that are reasonable in the circumstances to ensure that it remains not publicly available and
• that has actual or potential economic value to the person or their competitors because it is not publicly available and its disclosure would result in a material financial loss to the person or a material financial gain to their competitors

Following an assessment of the proposals, text within an in-scope document found to meet the above definition will be protected. Similar to Public Release of Clinical Information policies, any information that meets the definition of “clinical information” will not be considered confidential business information.

Exceptions to the PRCI regulations described in C.08.009.2(2)(a) and (b) of the Food and Drug Regulations or section 43.12(2)(a) and (b) of the Medical Device Regulations will be considered when applying redactions to confidential business information. Further information on the application of these exceptions can be found in the Health Canada PRCI guidance document.

All personal information should be anonymized in accordance with section 6 of the Public Release of Clinical Information guidance document.

The proposal package from the manufacturer should include:

• the proposed redaction control sheet
• the draft anonymization report
• annotated documents

Manufacturers submit for Health Canada assessment using either CanadaPost ePost Connect or a suitable secure file transfer site of the manufacturer’s choosing.

Step 2: Health Canada assessment of company representations

Within 30 days of receiving the proposal package, Health Canada will complete and return our assessment of the proposed CBI redactions and anonymization methodology. Proposed redactions that meet the definition of confidential business information will be protected. We will review the anonymization methodology to ensure all personal information is protected while maximizing the disclosure of useful clinical information.

Step 3: Revision of proposed CBI redactions and anonymization

If proposed CBI redactions are rejected or revision is required to the anonymization methodology, in accordance with the Public Release of Clinical Information: guidance document, the manufacturer will be given 15 days to make the revisions and resubmit. We will send our final assessment to the manufacturer within 5 days of receiving the revised package.

Step 4: Finalization and publication

Within 5 days of receiving our final assessment, the manufacturer must format and submit the final redacted and anonymization clinical documents within 5 days of receiving our final assessment. The final documents must comply with the Guidance Document: Preparation of Regulatory Activities using the Electronic Common Technical Document (eCTD) Format. These documents are to be submitted using the Common Electronic Submission Gateway. We will publish the final redacted documents within 5 days of receiving the final sequence.

Publication of safety and effectiveness information used to support medical device interim order applications

The publication of information within an interim order application will proceed through the abbreviated process described below. Our goal is to publish a final redacted and anonymized package on our clinical information portal within 120 calendar days from initiation of the process.

Step 1: Health Canada screening of requests

After we receive a request for information, we will retrieve the interim order application from docubridge (or other location).

Information related to safety and effectiveness will be considered in-scope of publication. Other information will not be released publicly. Only information available at the time the request is made will be considered for disclosure. Information submitted after the original request for disclosure will be considered for public release upon receipt of a subsequent request.

Examples of in scope information include:

• clinical testing information
• validation testing that supports the effectiveness of the product, including testing performed in vitro or in silico
• summaries or overviews on safety or efficacy pre- or post-market, including literature reviews

Examples of out of scope information include:

• manufacturing details not related to safety or efficacy
• engineering and design details
• general documents, such as user manuals, package inserts and instructions for use
• individual patient information, such as patient listings and case report forms, that require extensive anonymization
• interim clinical study data (see the PRCI guidance)

Step 2a: Health Canada assessment of confidential business information

To reduce administrative burden on the manufacturer, we will review in-scope records for confidential business information, as defined in Section 2 of the Food and Drugs Act, which mirrors common law in the context of confidential business information that meets each of the following 3 elements of the definition will be protected:

• that is not publicly available
• in respect of which the person has taken measures that are reasonable in the circumstances to ensure that it remains not publicly available and
• that has actual or potential economic value to the person or their competitors because it is not publicly available and its disclosure would result in a material financial loss to the person or a material financial gain to their competitors

Text in an in-scope document found to meet this definition will be redacted using a PDF redaction tool. Similar to Public Release of Clinical Information policies, any information that meets the definition of “clinical information” will not be considered confidential business information. Exceptions to the PRCI regulations are outlined section 43.12(2)(a) and (b) of the Medical Device Regulations. These exceptions will be considered when applying redactions to confidential business information. Further information on the application of these exceptions can be found in the PRCI guidance document.

Step 2b: Assessing personal information

In general, in-scope records do not contain a large volume of personal identification information. Any personal information, as defined in the Privacy Act and in accordance with PRCI guidance, information that could help to identify an individual will be protected. For example, this can include the names of authors and investigators as well as subject identification numbers.

A large volume of indirectly identifying information is not expected in the medical device records that are in-scope of publication. Consequently, limited protection of personal information is anticipated.

Personal information will be redacted using a PDF redaction tool.

Step 3: Notice to the company and request for redaction proposal

Following the review and redaction of in scope documents, we will send the manufacturer a written notice indicating our intent to publish the identified documents. A copy of the release package will be sent for the manufacturer’s review. Any further proposed redactions by the manufacturer must be received within 14 calendar days.

Manufacturer are asked to use the Proposed Redaction Control Sheet (see Appendix E of the PRCI guidance document) to suggest further redactions.

Step 4: Health Canada assessment of company representations

Any further redactions proposed by the manufacturer will be assessed in accordance with the process outlined in step 2, above. Those that meet the definition of personal or confidential business information will be accepted.

Step 5: Publication

In-scope documents will be published within 120 days following receipt of the request. The redacted information will be uploaded to the Clinical Information Portal, indexed by application number. Published documents will carry a watermark and be subject to terms of use, as described in the PRCI guidance.

Mailing address

Information Science and Openness Division
Resource Management and Operations Directorate
Health Products and Food Branch
Health Canada
Graham Spry Building
250 Lanark Ave
Ottawa ON K1A 0K9

Telephone: 613-960-4687
Email: hc.clinicaldata-donneescliniques.sc@canada.ca

Terminology and definitions

Anonymization:

means the process through which personal information is modified by:

• removing direct identifiers and any related code that would enable linkage with identifying information and
• ensuring that the remaining indirect identifiers no longer present a serious possibility of re-identifying an individual

CBI:

Confidential business information, as meant in common law and as defined in Section 2 of the Food and Drugs Act:

• in respect of a person to whose business or affairs the information relates, means (subject to the regulations) business information that:
• is not publicly available
• in respect of which the person has taken measures that are reasonable in the circumstances to ensure that it remains not publicly available
• has actual or potential economic value to the person or their competitors because it is not publicly available and its disclosure would result in a material financial loss to the person or a material financial gain to their competitors

Clinical information:

means information in respect of a clinical trial, clinical studies or investigational testing, such as:

• clinical overviews, clinical summaries and clinical study reports for drugs
• summaries and detailed information of all clinical studies and investigational testing that provided evidence of safety and effectiveness for medical devices

Clinical study report:

means an "integrated" full report of an individual study of any therapeutic, prophylactic or diagnostic agent (drug or treatment) conducted in patients, in which:

• the clinical and statistical description, presentations and analyses are integrated into a single report
• incorporating tables and figures into the main text of the report or at the end of the text
• appendices contain the protocol, sample case report forms, investigator-related information, information related to the test drugs/investigational products, including active control/comparators, technical statistical documentation, related publications, patient data listings and technical statistical details such as derivations, computations, analyses and computer output

FDA:

Food and Drugs Act

FDR:

Food and Drug Regulations

IMDRF ToC:

International Medical Device Regulators Forum Table of Contents

Medical device:

has the same meaning as insee the Medical Devices Regulations. For information on the classification of medical devices, please see the guidance documents on the:

• risk-based classification system for in vitro diagnostic devices (IVDDs)
• risk-based classification system for non-in vitro diagnostic devices (non-IVDDs)

Non-commercial purpose:

means the information will not be used to support a marketing authorization application anywhere in the world or sold or traded to another person

Personal information:

Has the same meaning as in Section 3 of the Privacy Act

Related links

• Clinical information request form
• Public Release of Clinical Information Guidance Document