Guidance on management of drug submissions and applications: Reconsideration of decisions, refiling
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Reconsideration of decisions
Reconsideration is a dispute resolution process designed to ensure that negative decisions are made in accordance with existing scientific and regulatory standards. The process is designed to look at the information in specific submissions or applications rather than address complaints about perceived systemic issues.
Health Canada tries to identify, manage and resolve disputes at the level at which they take place. Dispute prevention and early resolution usually take place through direct communication between directorates and sponsors of submissions or applications.
If mechanisms for early dispute resolution are not successful, you may file a formal request for reconsideration of certain decisions.
For more information, consult:
You may request a reconsideration after receiving a:
- rejection of priority review request
- rejection of request for advance consideration under the notice of compliance with conditions policy
- screening rejection letter (SRL)
- notice of deficiency-withdrawal (NOD-W)
- notice of non-compliance-withdrawal (NON-W) or
- not satisfactory notice (NSN) for a notifiable change (NC), PDC, PDC-B, clinical trials application (CTA) and amendments to a clinical trial application (CTA-A)
Issues not eligible for reconsideration are:
- decisions based on submissions or applications containing documented falsified information
- allegations of bias and complaints about the submission management process
You should address issues of this nature to the director of the relevant review area.
Refiled submissions and applications
A refiled submission and application is a new submission and is assigned a new control number and new filing date.
A refiled submission and application is subject to Health Canada’s policies, procedures and guidance documents that are in effect at the time of refiling. You should update your submission or application accordingly. The performance standards, matters related to intellectual property and fees for the submission or application type and class will apply.
Send refiled submissions or applications to the Office of Submissions and Intellectual Property (OSIP), along with up-to-date documents (for example, updated cover letter, submission certification form). Indicate the directorate that received the previously filed submission or application.
For CTAs and CTA-As, send the refiled submission or application to the:
- Office of Regulatory Affairs (ORA) in the Biologic and Radiopharmaceutical Drugs Directorate (BRDD) or
- Office of Clinical Trials (OCT) in the Pharmaceutical Drugs Directorate (PDD)
Before refiling a submission or application in an eCTD format, contact BFMD for technical advice on how to reference the new information with the original submission or application.
A refiled submission or application is one that a sponsor files after the following has taken place:
- issuance of an SRL
- cancellation of a submission or application by a sponsor
- issuance of an NOD-W or NON-W or
- issuance of an NSN
Refiling after a screening rejection letter
If you wish to refile a submission or application that received a SRL, you must resubmit all information for the submission or application. It is not acceptable to reference the original submission or application.
Refiling after cancellation by the sponsor
If you wish to refile a submission or application after cancelling it at any point during the processing, screening or review 1 period or following an NOD, you must resubmit all the information for the submission or application. It is not acceptable to reference the original submission or application.
Refiling a CTA or CTA-A after withdrawal by the sponsor
If you withdraw an application, you must resubmit all the information for the application and, if applicable, the information to address any deficiencies previously identified. The refiled information is a new application.
Refiling after a notice of deficiency withdrawal
If you wish to refile a submission or application any time after an NOD-W has been issued, you must resubmit all the information for the submission or application along with the information to address the deficiencies identified in the NOD or related withdrawal letter. It is not acceptable to reference the original submission or application.
Refiling in 5 years or less after a not satisfactory notice
If you wish to refile a submission or application within 5 years or less after an NSN has been issued, you must resubmit all the information, including the information to address the deficiencies identified in the NSN.
You should:
- provide a rationale for why the refiled information should be reviewed
- reference the previous control number of the original submission or application
- certify that all other information previously submitted is still the same
You should incorporate into the appropriate sections of the refiled submission or application, whichever is appropriate:
- Level II changes (biologic and radiopharmaceutical drug quality changes) for Division 8 drugs
- Level III changes for Division 8 drugs or
- PDCs for Division 1 drugs
For more information, consult the relevant guidance document:
- Post-drug identification number (DIN) changes
- Post-notice of compliance (NOC) changes: Quality document
- Post-notice of compliance (NOC) changes: Safety and efficacy document (for pharmaceutical, biologic and radiopharmaceutical drugs for human use only)
You should also provide a complete summary of the changes that have been included and reference the supporting data in the submission or application.
To increase the efficiency of the scientific review, you should:
- identify the new and original information that is being resubmitted
- reference the original submission or application where applicable
Refiling 5 years or less after an NON-W, a cancellation after an NON is issued (before an NON-W)
If you wish to refile a submission or application in 5 years or less after an NON has been issued (before an NON-W) or after receiving an NON-W, you are only required to resubmit the information to address the issues identified in the NON or NON-W letter. You should:
- give a reason for why the refiled information should be reviewed
- reference the control number of the original submission or application
- certify that all other information previously submitted is still the same
You should incorporate into the appropriate sections of the refiled submission or application, whichever is appropriate:
- Level II changes (biologic and radiopharmaceutical drug quality changes only) for Division 8 drugs
- Level III changes for Division 8 drugs or
- PDCs for Division 1 drugs
For more information, consult the relevant guidance document:
- Post-drug identification number (DIN) changes
- Post-notice of compliance (NOC) changes: Quality document
- Post-notice of compliance (NOC) changes: Safety and efficacy document (for pharmaceutical, biologic and radiopharmaceutical drugs for human use only)
You should also provide a complete summary of the changes that have been included and reference the supporting data in the submission or application.
To increase the efficiency of the scientific review, you should:
- identify the new and original information that is being resubmitted
- reference the original submission or application where applicable
Refiling more than 5 years after receiving an NON-W, cancellation after an NON (before an NON-W) or an NSN is issued
If you wish to refile a submission or application more than 5 years after receiving an NON-W, cancellation after an NON (before an NON-W) or NSN, you must resubmit all information for the submission or application and up-to-date documents (for example, cover letter, submission certification form). It is not acceptable to reference the original information. You should identify and certify any information that was submitted in the original submission or application that is still the same.