Frequently Asked Questions (FAQs) - The Use of Foreign Reviews by Health Canada
For the purposes of this project, what does the term 'health products' include?
For the purposes of this project, human and veterinary biologicsFootnote 1, disinfectants, radiopharmaceuticals and pharmaceuticals (hereafter referred to as drugs), and medical devices are collectively referred to as 'health products'.
What products are considered in the scope of the Use of Foreign Review project and the pilot?
The list of products under the scope for the Use of Foreign Review pilot phase of the project (October 2011 to March 31, 2013) will be the same as the scope under the draft guidance document The Use of Foreign Reviews by Health Canada.
- New Drug Submissions (drugs);
- Abbreviated New Drug Submissions (drugs);
- Supplement to a New Drug Submissions (drugs);
- Supplement to a Abbreviated New Drug Submissions (drugs);
- Drug Identification Number Applications (drugs);
- Class III and IV Licence Applications (medical devices);
- Class III and IV Licence Amendment Applications (medical devices);
Notifiable Changes (drugs), Risk Management Plans (drugs), Periodic Safety Update Reports and evidence provided to confirm the continued safety and effectiveness of a marketed product (drugs and medical devices) are also included.
What does the Use of Foreign Reviews (UFR) initiative hope to achieve and how will it benefit Canadians?
For the past several years, Health Canada has been actively engaged in international cooperation initiatives and has, on occasion, used review assessment information from regulatory agencies of other jurisdictions (for example, European Medicines Agency) when reviewing a health product seeking market authorization in Canada.
Foreign regulatory counterparts with a similar regulatory system to Health Canada provide a wealth of information to take into consideration when reviewing the safety, efficacy, and quality of health products.
The UFR initiative will enable Health Canada to make use of a broader array of information while making health product submission review decisions by consistently applying best practices and will provide formal guidance to industry sponsors on how this foreign regulatory information will be applied in Health Canada's decision making process.
The objectives of the UFR project are to:
- enhance the quality of Health Canada regulatory assessments; and
- assist Health Canada in meeting performance targets for regulatory assessments while maintaining the integrity of Health Products and Food Branch's (HPFB's) regulatory review process; and
- Canadians' timely access to safe, efficacious, and high quality health products.
Will the use of foreign review project allow health products to be approved and introduced into the market more quickly?
In some cases, it is possible that the amount and quality of information available from a foreign regulatory counterpart may lead to a faster than typical review period. However, Health Canada's regulations and standards for health product submissions must be met in order for a health product to be authorized for sale in Canada.
Before any health product can be authorized for sale in Canada, Health Canada needs to be assured that its benefits outweigh its potential risks. Information provided from a foreign review may provide additional information regarding these two aspects.
How will this initiative change Health Canada's health product regulations?
This initiative will not change Health Canada's health product regulations and required safety standards.
Health Canada's health product regulations and standards are among the most rigorous in the world and Health Canada will continue to apply the necessary regulatory oversight. The information provided from a foreign review may assist Health Canada in making a well informed decision to continue to provide safe and effective products for Canadians.
Will the use of foreign reviews mean that decisions to allow health products to be sold in Canada will be made by other jurisdictions?
No. All final regulatory decisions to grant or refuse market authorization must be made by the Minister of Health. Health Canada will not compromise the integrity of its regulatory review process and Canadians' timely access to safe, efficacious, and high quality health products.
Taking into account information from foreign regulatory authorities with similar regulatory systems and requirements adds to Health Canada's knowledge and broadens our perspective in helping Health Canada make the strongest decisions possible.
Will this 'harmonize' our health product safety standards with regulators in other countries?
No. This initiative will not harmonize Canadian health product legislation or regulations with those of any foreign regulatory counterpart. It will not bring about any changes in legislation and regulation. This initiative is to formalize the use of foreign regulatory information in Canada's regulatory review processes for health products.
Can a foreign review from any foreign authorities be submitted to Health Canada for review?
Health Canada will consider a foreign review from any foreign authority. It is review management's responsibility to decide on the appropriate method for using a foreign review for a given application/submission (or component thereof) in accordance with HPFB's Standard Operating Procedures (SOP) on the use of foreign reviews.
Will Health Canada delay the market authorization of a health product if the market authorization holder did not submit a foreign review with the application?
Market authorization holders are strongly encouraged to file foreign review data packages in a timely fashion. Health Canada will not delay the market authorization process until a foreign review is available.
Health Canada may not use a foreign review if it is received late in the Canadian market authorization process.
If the market authorization holder does not provide a foreign review, will Health Canada request a foreign review from a foreign regulator?
If Health Canada does not receive a foreign review, it may request it from a foreign regulator. When requesting a foreign review, Health Canada will notify the market authorization holder of its intent to do so.
Will the foreign reviews be subject to Access to Information request?
Health Canada must follow the Access to Information Act. Requests for access to foreign reviews through the Access to Information request will be based on interpretation of the Access to Information Act.
Will the foreign reviews be posted on Health Canada's website or be shared with any other group outside of Health Canada?
The foreign reviews will not be posted on the Health Canada website. Health Canada will not share foreign reviews without the consent of the market authorization holder and/or the foreign regulatory authority. However, Health Canada must follow the Access to Information Act.
How will the decision be made on the extent to which the foreign review will be utilized in product authorization process of a given submission?
The extent to which a foreign review may be used in Health Canada's marketing authorization review process will be guided by review management's assessment of an appropriate method for using a foreign review for a given application/submission (or component thereof) in accordance with the Standard Operating Procedures (SOP) on the use of foreign reviews.
How will consistency in decision making across the different review groups be monitored?
To ensure the consistency in the review process each directorate within the scope of this project have developed Standard Operating Procedures (SOP) to assist in their reviews processes.
How can I obtain a copy of the Foreign Review Attestation Template?
Blank Foreign Review Attestation Templates are available online, in English and French, in Portable Document Format (PDF) at:
If you have any issues in receiving a blank Foreign Review Attestation template through the link provided above, please contact the Use of Foreign Regulatory Information Steering Committee at UFRI_URRE@hc-sc.gc.ca.
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