Draft Guidance Document for Notifying Health Canada of Foreign Risk

Health Canada is the federal department responsible for helping the people of Canada maintain and improve their health. We assess the safety of drugs and many consumer products, help improve the safety of food, and provide information to Canadians to help them make healthy decisions. We provide health services to First Nations people and to Inuit communities. We work with the provinces to ensure our health care system serves the needs of Canadians.

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The purpose of this (draft) guidance document is to provide manufacturers, importers and other holders of instruments of market authorization (Drug Identification Numbers (DIN) and Notices of Compliance (NOC)) under the Food and Drug Regulations (FDR) < insert link >, with information  that may be useful in achieving compliance with the proposed new regulatory requirement to notify Health Canada of foreign risk communications, label changes, recalls, etc. as per proposed sections C.01.050(2)(a), (b) and (c).

Table of Contents

1 Introduction

1.1 Purpose

The purpose of this (draft) guidance document is to provide manufacturers, importers and other holders of instruments of market authorization (Drug Identification Numbers (DIN) and Notices of Compliance (NOC)) under the Food and Drug Regulations (FDR) < insert link >, with information  that may be useful in achieving compliance with the proposed new regulatory requirement to notify Health Canada of foreign risk communications, label changes, recalls, etc. as per proposed sections C.01.050(2)(a), (b) and (c).

1.2 Background

The foreign notification provisions in the FDR are intended to improve the collection and assessment of new safety information involving regulatory issues in foreign countries and help determine an appropriate response in Canada to these issues.  As many drugs may be marketed years in advance or in higher volume in other countries, important safety signals may be detected earlier in a foreign jurisdiction.

The intended outcome is that the Minister will have knowledge of regulatory actions taken in foreign jurisdictions to mitigate serious risks which will allow Health Canada to assess risks to Canadians and take appropriate action to mitigate those risks when warranted.

1.3 Scope

This (draft) guidance document is intended as a supplement to the proposed regulations, to aid in the interpretation of the proposed new requirement to notify Health Canada of foreign regulatory actions.

2. Interpretation

2.1 What kinds of foreign action would require authorization holders to notify Health Canada?

The proposed amendment to the FDR would require the holder of an authorization (made through the assignment of a DIN or issuance of a NOC) to provide the Minister with information in respect of any serious injury to health of which the holder becomes aware, and  is relevant to the safety of the drug, including information regarding:

  • risks related to a manufacturing issue, such as a Good Manufacturing Practices (GMP) deficiency, that are communicated by certain foreign regulatory authorities or manufacturers within those jurisdictions (C.01.050(2)(a));
  • risks related to a new contraindication or warning, that is communicated by certain foreign regulatory authorities or manufacturers within those jurisdictions (C.01.050(2)(a));
  • changes to the labelling communicated to or requested by certain regulatory authorities (C.01.050(2)(b)) (e.g. new dosages, indications, directions for use, warning statements, contraindications, plain language);
  • recalls conducted within certain foreign regulatory jurisdictions (C.01.050(2)(c));
  • reassessments of market authorizations, which resulted in a change to risk mitigation measures for a drug or the addition of enhanced vigilance requirements, within certain foreign regulatory jurisdictions (C.01.050(2)(c));
  • the suspension or revocation of manufacturing authorizations (e.g. site licences) within certain foreign regulatory jurisdictions (C.01.050(2)(c)); and
  • the suspension or revocation of market authorizations (e.g. NOC, permission to sell) within certain foreign regulatory jurisdictions (C.01.050(2)(c)).

This information would be required to be provided to the Minister within 48 hours of the holder receiving it, or becoming aware of it so as to allow the Minister to determine without delay if similar risks exist for those drugs in Canada and which action(s) would be required to mitigate these risks.

2.1.1 What drugs are subject to the proposed requirements?

Adopting a risk-based approach, the proposed requirement to notify Health Canada of foreign regulatory action will apply to the following two classes of drugs:

  • prescription drugs; and
  • drugs that are permitted to be sold without a prescription but that are administered only under the supervision of a practitioner.

2.1.2 Which foreign regulatory authorities are encompassed by the proposed requirements?

A list of foreign regulatory authorities maintained by Health Canada would be incorporated by reference in the FDR. This list would include the United States Food and Drug Administration (US FDA), the European Medicines Agency (EMA) and the regulatory authorities of its member-states, the Australian Therapeutic Goods Administration (TGA), the Swiss Agency for Therapeutic Products, and the Health Sciences Authority of Singapore. The list is attached as Appendix A to the Regulatory Impact Analysis Statement (RIAS).

2.2 Key elements for consideration about serious risk

The proposed regulations will require a holder of an authorization to notify Health Canada about certain actions taken and information communicated by foreign regulatory authorities only with respect to a serious risk of injury to health. Consequently, the reporter will have to determine if the risk meets this threshold. This determination is complex and should be made in consultation with a medical professional, when appropriate.

This non-exhaustive list of elements should be considered together as the starting point for making a determination of serious risk:

  • The seriousness of the adverse health consequence. A serious adverse health consequence includes any untoward occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. This element should be given the most weight when making a determination of serious risk.
  • A change in the nature or frequency of a serious adverse health consequence posed by the drug;
  • The probability of the serious adverse health consequence upon exposure to the drug.
  • The vulnerability of the patient population and/or sub-population that are exposed to the particular drug. Vulnerable populations may include, but are not limited to: children, the elderly, pregnant and lactating women, and immunocompromised patients.
  • The extent of the population's exposure to the drug and the potential public health impact of the exposure.

2.3 Examples of foreign actions requiring notification of Health Canada

2.3.1 Quality-related issues

  • A recall of a prescription drug is conducted in the United States due to a reasonable probability that the use of, or exposure to, the drug would cause serious adverse health consequences or death (i.e. a Type I recall).
  • A recall of a non-prescription drug that is administered under the supervision of practitioners is conducted in Australia as the product was causing a temporary adverse health consequence in a vulnerable subpopulation.
  • The Health Products Regulatory Authority in Ireland issues a safety notice indicating a contravention in GMP in the manufacturing of a prescription drug that increases the probability, nature or frequency of a serious adverse health consequence.
  • The Medicines and Healthcare products Regulatory Agency of the United Kingdom suspends a manufacturer licence for a non-prescription drug that is administered under the supervision of practitioners due to finding of a critical deficiency in GMP following an inspection.

2.3.2 Other safety-related issues

  • A public warning is issued by Australian TGA concerning a prescription drug when it is discovered that a serious new safety concern exists when the drug is used in combination with certain foods.
  • It is announced in the US that the standard label of a generic pain medication has been changed to include warnings regarding use in children under the age of 12, relating to serious long-term health effects.
  • The license of an anticoagulant is revoked in the EU when a rare but serious adverse reaction is discovered after many years on the market. 
  • Marketing is suspended in France pending a safety assessment to establish the risk profile of a drug with a narrow safety range, in the context of rapidly increasing off-label use.

2.4 What kind of information needs to be included?

In order to comply with this proposed provision it is expected that authorization holders will provide the following information, as applicable:

  • The brand name and manufacturer of the foreign product
  • The brand name and DIN of the relevant Canadian product
  • The foreign regulatory authority that took the action and/ or the foreign jurisdiction in which the action occurred
  • The action taken by the foreign regulatory authority or the action taken by company in the foreign jurisdiction that took the action
  • The reasons (or information about those reasons) for the action (i.e. product quality/GMP vs. product safety/adverse reaction/unsafe use)
  • An explanation of how the issue that resulted in foreign action is relevant to the safety of the product sold in Canada

Authorization holders are also asked to provide

  • The applicable section and subsection of the Canadian regulations that requires the information about the foreign action to be provided to Health Canada.
  • An assessment as to the risk level to Canadians
  • Any actions proposed or taken in Canada by the authorization holder in response to the serious safety issue

It is not necessary to provide original documents (recall notices, risk communications, notification of label change, etc.).

2.5 What is the process for notifying Health Canada of foreign actions?

The required information will likely be submitted to Health Canada using an electronic submission (details to follow).

2.6 Language notification reports

Notification reports must be in either English or French.  Additional documents (e.g. recall notices, risk communications) relating to the issue may be provided voluntarily but are not required by regulation and would not need to be translated, if provided.

2.7 Are regulated parties required to monitor foreign regulatory action?

Authorization holders are expected to practice sufficient environmental scanning to comply with section C.01.050.  For example, a market authorization holder needs to make a reasonable attempt to monitor the activities of the listed foreign regulatory authorities as they relate to the kind of issues and products referred to in the regulation, and determine the relevance of the actions to products sold in Canada. This monitoring would start with environmental scanning, the scope of which could be expected to include:

  • Monitoring information sources from listed authorities for relevant activities (communication of risks, changes to labelling, recalls, etc.);
  • Screen for information involving “serious risk of injury to human health;”
  • Determine relevance to prescription or practitioner-administered drugs sold in Canada by the MAH.

Environmental scanning needs to be conducted systematically by qualified people and documented in a way that would enable self- and regulatory auditing. For additional information on expectations for environmental scanning, please refer to the Guideline for Preparing and Submitting Summary Reports < link TBD >.

2.8 How will compliance be monitored and assessed?

In order to comply with the requirements of this proposed regulation, the authorization holder is expected to have in place and maintain:

  • a documented system to receive, assess and report on foreign regulatory actions within the scope of the regulation.  This would include relevant quality documents such as SOPs.
  • operational records sufficient to enable the regulator to determine compliance (showing information received, assessed, decisions and actions taken, etc.)

This capacity may be assessed during inspection. As well, compliance with these regulations may also be verified through reconciling incoming notification reports with information gathered by Health Canada through other means, such as Mutual Recognition Agreements with foreign regulatory authorities or environmental scanning in house.

2.9 Will notification reports be publicly accessible?

Documents received and generated under this requirement will be handled and shared according to current transparency provisions relating to the results of safety reviews and establishment licensing decisions. These include:

  • Regulatory transparency and openness
  • Safety Reviews
  • New Safety Reviews
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