The Ministerial Reliance Order: About the Order
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What is the Ministerial Reliance Order
The Order Providing for Reliance on Decisions of, or Documents produced by, Foreign Regulatory Authorities in Respect of Certain Drugs (the Order) allows Health Canada to rely on decisions or documents made by comparable foreign regulatory authorities (FRAs) for certain drug submissions. It makes Health Canada's review process more efficient for drugs that have already been approved or evaluated by a comparable FRA.
The first submissions eligible under the Order are certain classes of human and veterinary drugs included in the Incorporated by Reference (IbR) list.
The Order is one of Health Canada's commitments to reduce red tape.
How deeming works
When we review a submission to authorize a drug for use in Canada, we make sure the submission meets all of the requirements set out in the Food and Drug Regulations. Among other requirements, the submission must demonstrate that the drug is safe and effective and of high quality.
The Order "deems" that the requirement for Health Canada to review certain parts of a drug submission is complete if the requirements under the Order are met. The review of the non-clinical information, clinical information, and chemistry and manufacturing information in a drug submission may be eligible for deeming under the Order.
Our decision to deem is based on the fact that a comparable FRA has either:
- given approval for the foreign drug or
- produced a document based on its review of a certain portion of the foreign drug submission
The Order applies only to defined classes of drugs that are paired with certain comparable FRAs. These are identified in the list that's incorporated by reference into the Order.
- List of classes of drugs and foreign regulatory authorities for the purposes of reliance on decisions or documents (IbR List): Human drugs
- List of classes of drugs and foreign regulatory authorities for the purposes of reliance on decisions or documents (IbR List): Veterinary drugs
Manufacturers can seek deeming for a drug that's considered the same using 1 of 3 options, as applicable:
- general deeming
- 120-day filing
- joint review
General deeming is:
- used when a foreign drug is already authorized by a comparable FRA, but the product or indication hasn't been approved in Canada
- meant to encourage manufacturers to bring more drugs to Canada
120-day filing is:
- used when a manufacturer submits a drug submission to a comparable FRA and then also files the submission with Health Canada within 120 days
- As there is no foreign authorization yet, deeming could only occur if the FRA authorizes the foreign drug.
- meant to reduce the amount of time between filing in Canada and to a comparable FRA
Joint review is:
- used when Health Canada reviews a drug submission along with 1 or more comparable FRAs and relies on parts of the review by the other regulatory authority
- meant to reduce any duplication that may arise from working on review reports for parts of the submission that were reviewed by another regulatory authority
Manufacturers must meet a number of requirements for deeming to occur. For example, they must:
- demonstrate that the drug proposed for sale in Canada has the same medicinal ingredient(s), strength, dosage form and route of administration as the drug authorized or submitted to the FRA
- demonstrate that the conditions of use of the drug proposed for sale in Canada fall within those authorized or submitted to the FRA
- for example, the drug is to be used in the same patient population
- indicate if there are differences between the drug they want to bring into Canada and the drug that was approved by the comparable FRA
- show that the differences would not affect the safety, effectiveness or quality of the drug
Reducing red tape through the Order
The Food and Drugs Act and its regulations give us the authority to regulate health products such as drugs, medical devices, food and cosmetics. For new drugs, this means reviewing the safety and effectiveness information that a manufacturer submits when it wants to bring a drug to Canada.
Drug submissions are becoming more complex and we're receiving far more drug submissions in recent years. As well, expectations around accessing new drugs faster have risen.
Health Canada takes part in international initiatives and works with international bodies to help reduce duplication and promote international harmonization.
For example, we take part in 2 international councils that develop and promote common scientific and technical standards:
- the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and
- the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH)
Adopting these standards means regulators like Health Canada share similar expectations for evidence as other foreign regulators. Initiatives like the Access Consortium also support regulatory alignment for human drugs.
Other examples include:
- signing mutual recognition agreements with other countries, to establish common good manufacturing practices
- relying on inspection reports to reduce duplication between international partners
Reliance activities, including leveraging foreign review reports, occurs in many countries and Canada has historically leveraged foreign reports in our review of drug submissions. This Order gives us the clear authority to now allow for the deeming that certain requirements are complete based on decisions and documents made by other comparable foreign regulators. It is another tool we can use to make the review process more efficient when approving drugs for use in Canada. The Order builds on internationally harmonized standards and the collaborative relationships we already have with other countries.
We hope that manufacturers will be encouraged to bring human and veterinary drugs to Canada that wouldn't otherwise come, such as drugs for pediatric populations, tuberculosis and those most requested through the Special Access Program.
This should allow us to focus our energy and resources on submissions where we make the biggest impact and where we create the most value for the public, while continuing to uphold our requirements for safety, efficacy and quality.
Learn more:
- New draft guidance on Ministerial Reliance Order concerning decisions or documents on certain drugs by foreign regulatory authorities: Notice
- Improving access to drugs
- How drugs are reviewed in Canada
- About Canada's health care system
- Access to drugs in exceptional circumstances
- Special access drugs most often requested
- Drug system snapshot (infographic, PDF)
- Drug access in Canada: Understanding the system
- International collaboration for veterinary drugs