Draft guidance on Ministerial Reliance Order concerning decisions or documents on certain drugs by foreign regulatory authorities: Overview
On this page
- Purpose
- Introduction
- Scope and application
- Policy objectives and statements
- Definitions
- Note about guidance documents in general
Purpose
This draft guidance sets out the regulatory requirements and process for filing a human or veterinary new drug submission, abbreviated new drug submission or supplement to either such submission when a manufacturer is seeking deeming under the Ministerial Reliance Order. This Order is titled the Order Providing for Reliance on Decisions of, or Documents Produced by, Foreign Regulatory Authorities in Respect of Certain Drugs.
Introduction
The Food and Drugs Act and its regulations give Health Canada the authority to regulate food, drugs, medical devices and cosmetics. All drugs to be marketed for human and veterinary use in Canada are reviewed to ensure they meet the requirements of the act and its regulations.
Health Canada's role as the federal regulator for drugs is to evaluate the information supporting a drug submission through scientific assessments of the evidence. The supporting information must demonstrate that the drug:
- is safe for human and veterinary use, with acceptable risks compared to benefits
- is effective for the intended treatment or condition
- meets quality standards in manufacturing, purity and consistency
To strengthen and expand the use of documents and decisions from comparable foreign regulators during the review of drug submissions, the Minister of Health made the Order.
The Order:
- deems the requirement for the Minister to examine specified information and material in certain drug submissions filed under Part C, Division 8 of the Food and Drug Regulations to have been met based on decisions or documents by comparable foreign regulatory authorities
- enables the Minister to rely on decisions or documents from listed comparable foreign regulatory authorities in the review of submissions for specific drug classes and
- deem certain examination requirements to be met while retaining the ability to make a positive or negative decision to authorize a drug on the basis of information examined by the Minister
For use of reliance, a manufacturer must request deeming when filing a drug submission in Canada. A manufacturer must submit a complete regulatory submission in accordance with applicable filing requirements under the Food and Drug Regulations. Deeming can only occur when specific requirements set out in the Order are met.
Manufacturers must demonstrate that:
- the proposed Canadian drug has the same strength, dosage form, route of administration and medicinal ingredients as the foreign drug
- the proposed Canadian drug falls within a drug class with a corresponding foreign regulatory authority (FRA) listed on an Incorporation by Reference (IbR) list and
- a submission or supplement for the proposed Canadian drug from the manufacturer has not been previously withdrawn or received a negative decision from Health Canada
The Order will allow for deeming in some cases. This applies even where there are certain differences between the foreign drug and the drug filed in Canada related to the sets of information within a submission that the manufacturer seeks to have deemed. These differences must not negatively impact the safety and effectiveness of the drug.
If the differences between the foreign drug and the drug submitted for Health Canada review could negatively impact its safety and effectiveness, deeming would not be used for that part of the submission. A full examination would then take place. If the differences would not impact its safety or effectiveness, deeming could still occur for that part of the submission. An examination of all information related to the differences would take place because the FRA would not have reviewed this information.
The Order is intended to encourage manufacturers to file drug submissions in Canada.
While continuing to rigorously uphold Health Canada's high standards for safety, efficacy and quality, the Order aims to:
- improve efficiency
- reduce duplication in the review process based on examinations completed by FRAs
- allow Health Canada to focus our regulatory resources more effectively on higher-risk and more complex submissions
Manufacturers have the option to formerly align reviews of qualifying submissions in partnership with health technology assessment organizations (HTAs). Manufacturers are encouraged to opt into an aligned review process when filing a submission under the Order. When manufacturers choose this alignment and file in parallel to Health Canada and HTAs, it enables submissions to move more quickly to a reimbursement recommendation. This further promotes faster access to drugs in Canada.
For more information on aligned reviews refer to:
The Order supports, but doesn't replace, existing international collaboration mechanisms. It complements ongoing initiatives such as work-sharing, joint reviews and mutual recognition arrangements.
Leveraging international collaboration will allow Health Canada to focus resources as needed, while still maintaining oversight of health product approvals in Canada. This approach is expected to strengthen international regulatory collaboration over time. It will also help Canada respond more quickly to issues like drug supply disruptions, unmet medical needs and emerging health or safety concerns.
Scope and application
This guidance applies to the following types of human and veterinary drug submissions regulated under Part C, Division 8 of the regulations that may be eligible for deeming under the Order:
- new drug submissions (NDSs)
- abbreviated NDS (ANDSs)
- supplements to NDS (SNDSs)
- supplements to ANDS (SANDSs)
It doesn't apply to:
- extraordinary use new drug submissions (EUNDSs) or their supplements
- may be revised at a later date
- abbreviated extraordinary use new drug submissions (AEUNDSs) or their supplements
- may be revised at a later date
- submissions for public health emergency drugs
- submissions for drugs outside the scope of the IbR list
This guidance doesn't replace current regulatory requirements or existing guidance on filing or managing drug submissions, intellectual property or post-market obligations.
Rather, it provides direction on how Health Canada interprets and applies the provisions of the Order to support consistent, transparent and efficient regulatory decision-making. It outlines our approach to implementing the Order describing the:
- evidentiary expectations
- conditions under which deeming may occur, including eligibility criteria
- responsibilities of manufacturers when seeking deeming based on a foreign authorization or foreign regulatory authority document
Policy objectives and statements
To be authorized for sale, drugs for human and veterinary use must meet all applicable requirements in Part C, Divisions 1, 3 and 4 of the regulations. Drugs that meet the definition of a new drug under Part C, Division 8 of the regulations must also satisfy the requirements of Division 8. If there is enough scientific evidence to support the safety, efficacy or quality of a new drug, Health Canada will grant a market authorization for the drug.
Drug classes will be added to the IbR list only if:
- a particular drug class is necessary for public health, or is otherwise in the public interest, and
- the drugs in the class do not introduce unacceptable risks or uncertainties to health, safety or, where applicable, the environment
Other factors we will consider include the risk profile of the class of drugs. We may add a corresponding FRA to the IbR List after assessing whether its regulatory practices are comparable to ours.
To apply the Order, certain conditions must be met, such as:
- the proposed Canadian drug falls within a class of drugs listed on the applicable part of the IbR list
- the manufacturer demonstrates that the drug has been authorized by an FRA on the IbR List that relates to the class
- the proposed Canadian drug has the same strength, dosage form, route of administration and medicinal ingredient as the foreign drug
- the conditions of use for the proposed Canadian drug fall within those authorized by the FRA for the foreign drug
- there are no differences between the proposed Canadian drug and the foreign drug related to parts of the submission for which deeming is being sought that would negatively affect the drug's safety or efficacy
- the authorization granted by the FRA for the foreign drug was not reliant on a decision by another foreign regulator, unless it involved a joint review between the FRA and the other foreign regulator on the applicable part of the IbR list
- a prior submission or supplement filed by the manufacturer for the proposed Canadian drug has not previously been withdrawn or cancelled after receiving a notice of deficiency or non-compliance or refusal from Health Canada
The filing requirements for submissions under the Food and Drug Regulations are not affected by this Order. In other words all submission requirements under the regulations must still be met where deeming is requested.
Manufacturers are responsible for ensuring that the information they submit is complete and accurate. This includes evidence supporting deeming under the Order based on a FRA authorization or document. Also, once a notice of compliance (NOC) is issued, all post-market requirements will apply to the drug to which the Order applies, as they do for any drug authorized in Canada.
Health Canada is committed to being transparent and consistent when using deeming to support regulatory decision-making.
Under the Order, there are regulatory requirements specific to the Canadian context that the Minister will always examine when a drug is proposed for sale in Canada. Examples include labelling, bilingual requirements, risk management plans and withdrawal periods (veterinary drugs for administration to food-producing animals).
A manufacturer must also demonstrate that any differences in the proposed Canadian drug and the drug authorized by the FRA concerning the part of the submission for which deeming is being sought would not negatively impact its safety or effectiveness. The Minister will examine this information.
Definitions
- Abbreviated new drug submission:
- An abbreviated new drug submission filed under section C.08.002.1 of the regulations.
- Corresponding foreign drug:
-
For a drug that's the subject of a new drug submission, an abbreviated new drug submission or a supplement to either such submission, means:
- the foreign drug (referred to in subparagraph 2(1)(c)(i), clause 3(2)(b)(ii)(A), subparagraph 5(1)(c)(i), subparagraph 6(1)(c)(i) or clause 7(2)(b)(ii)(A) of the Order, as the case may be) and(b) any other drug that meets the following criteria:
- in the case of a new drug submission or an abbreviated new drug submission:
- it belongs to the class of drugs to which the drug that is the subject of the submission belongs,
- it has the same strength, dosage form, route of administration and medicinal ingredient as the drug, and
- it has conditions of use that fall within the conditions of use of that drug; and
- in the case of a supplement to a new drug submission or to an abbreviated new drug submission:
- it belongs to the class of drugs to which the drug that is subject of the supplement belongs,
- it has the same strength, dosage form, route of administration and medicinal ingredient as that drug, as it would be approved if the Minister were to issue a notice of compliance in respect of the supplement, and
- it has conditions of use that fall within the conditions of use of that drug, as it would be approved if the Minister were to issue a notice of compliance in respect of the supplement
- in the case of a new drug submission or an abbreviated new drug submission:
- the foreign drug (referred to in subparagraph 2(1)(c)(i), clause 3(2)(b)(ii)(A), subparagraph 5(1)(c)(i), subparagraph 6(1)(c)(i) or clause 7(2)(b)(ii)(A) of the Order, as the case may be) and(b) any other drug that meets the following criteria:
- Drug:
- Under the Order refers to new drug but doesn't include a public health emergency drug.
- Classes of drugs:
- The groupings of drugs as identified and characterized on the IbR list that may be eligible for deeming under the Order.
- Foreign authorization:
- The application for authorization to sell the foreign drug approved by the foreign regulatory authority listed on the IbR List against the relevant class of drugs.
- Foreign regulatory authority (FRA):
- A government agency or other entity outside Canada that has a legal right to control the manufacturing, use or sale of drugs within its jurisdiction listed in the IbR list.
- Incorporated by Reference (IbR):
- A mechanism that allows a document to be made a part of a regulation without having to include the document in the text of the regulation. The incorporated wording has the same effect as if it appeared in the regulation and is legally binding.
- List:
- Refers to the Government of Canada's "List of Classes of Drugs and Foreign Regulatory Authorities for the Purposes of Reliance on Decisions or Documents", as amended from time to time.
- Manufacturer:
- A person, including an association or partnership, who under their own name, or under a trade-, design or word mark, trade name or other name, word or mark controlled by them, sells a food or drug.
- Ministerial Reliance Order (Order):
- An order made under section 30.6 of the Food and Drugs Act designed to deem specific parts of the Minister's examination of drug submissions as complete based on decisions or documents produced by a foreign regulatory authority. The Order is a class order. It applies to specific classes of drugs identified in the Order. The Order will include an Incorporated by Reference (IbR) list, which sets out classes of drugs and foreign regulatory authorities within its scope.
- New drug submission:
- A new drug submission filed under section C.08.002 of the regulations.
- Notice of compliance (NOC):
- As issued under section C.08.004 of the regulations.
- Post-market measure:
-
Refers to any measure that a foreign regulatory authority provides for in respect of a foreign drug for any of the following purposes:
- optimizing the benefits and managing the risks associated with the foreign drug
- managing significant uncertainties relating to those benefits and risks
- collecting information to enable the continuous assessment of those benefits and risks, the identification of any changes to them and the management of the uncertainties
- Regulations:
- Food and Drug Regulations.
- Supplement:
- A supplement filed under section C.08.003 of the regulations.
Note about guidance documents in general
Guidance documents provide assistance to industry and health care professionals on how to comply with governing statutes and regulations. They also provide guidance to Health Canada staff on how mandates and objectives should be met fairly, consistently and effectively.
Guidance documents are administrative, not legal, instruments. This means that flexibility can be applied. However, to be acceptable, alternate approaches to the principles and practices described in this document must be supported by adequate justification. They should be discussed in advance with the relevant program area to avoid the possible finding that applicable statutory or regulatory requirements have not been met.
As always, Health Canada reserves the right to request information or material, or define conditions not specifically described in this document, to help us adequately assess the safety, efficacy or quality of a therapeutic product. We are committed to ensuring that such requests are justifiable and that decisions are clearly documented.
This document should be read along with the relevant sections of the regulations and other applicable guidance documents.