Review of your Application

All Clinical Trial Applications (CTAs) and Clinical Trial Application Amendments (CTA-As) are subject to a 30-day default review period from the date of receipt of a complete application in Health Canada.

Health Canada targets to review applications to conduct comparative bioavailability trials and Phase I trials in healthy adult volunteers within 7 days (for both CTAs and CTA-As), with the exception of Phase I trials using somatic cell therapies, xenografts, gene therapies, prophylactic vaccines or reproductive and genetic technologies. Note that all CTAs and CTA-As are subject to the 30-day default review period and the 7-day review period is an administrative target only.

All applications are screened for acceptability. If deficiencies are identified, either additional information is requested (Clarifax), or the application is rejected (Screening Rejection Letter). If the application is deemed acceptable for review, an acknowledgement letter is issued to the sponsor.

Once accepted for review, the screened applications are forwarded for Clinical and/or Quality evaluation. During the review period, additional information may be requested (Clarifax). The application is either authorized (a No Objection Letter is issued) or rejected (a Not Satisfactory Notice is issued).

Screening of CTAs and CTA-As

All CTAs and CTA-As will be screened for acceptability, and deficiencies identified at screening will be addressed by issuing one of the following:

Request for Clarification (Clarifax)

A Clarifax is issued when revisions and/or clarifications regarding the CTA or CTA-A are required. Requests for clarification that are issued during screening should be responded to within 2 calendar days [C.05.009]. A Rejection Letter will be issued if a timely response to a Clarifax has not been provided.

Screening Rejection Letter

A Screening Rejection Letter is issued when significant information requirements have not been included in the CTA or CTA-A. Sponsors will be issued a letter itemizing each deficiency. If the sponsor wishes to resubmit the information and material at a later date, it will be processed as new information and material, and will be assigned a new control number.

An application must be accepted in screening before it is processed for review. If the application is deemed acceptable for review, an acknowledgement letter will be issued to indicate the start of the review period.

Review of CTAs and CTA-As

Once accepted at the screening stage, the application is forwarded for evaluation:

• Clinical review - Module 1 (Safety and Efficacy), and/or
• Quality review - Modules 2 and 3 (Quality - Chemistry and Manufacturing).

Request for Clarification (Clarifax)

Issues identified during the review are addressed by Clarifax. The sponsor is responsible for resolving issues identified by Health Canada and must provide the information requested by Clarifax within 2 calendar days [C.05.009].

Not Satisfactory Notice (NSN)

A Not Satisfactory Notice (NSN) will be issued if significant deficiencies are identified during the review of the CTA or CTA-A, or if a timely response to a Clarifax issued has not been provided. If the sponsor wishes to resubmit the information and material at a future time, it will be processed as new information and material, and will be assigned a new control number.

No Objection Letter (NOL)

If there have not been any deficiencies identified (Clinical and/or Quality) and the CTA or CTA-A is deemed acceptable, a No Objection Letter (NOL) will be issued within the review period. Sponsors of trials which qualify for the 7-day administrative target review process can only proceed if:

• a No Objection Letter (NOL) is received from Health Canada prior to the 30 day default period, or
• within 30 days after the receipt of the application, a notice in respect of the drug, indicating that the sponsor may not sell or import the drug, has not been received.