Guidance on management of drug submissions and applications: Processing and screening
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Processing submissions and applications
All information received by the Office of Submissions and Intellectual Property (OSIP) is processed and sent to the appropriate review work area within 10 calendar days of receipt. Exceptions are clinical trial applications (CTAs) and amendments to clinical trial applications (CTA-As), which are submitted to the appropriate directorate:
- Pharmaceutical Drugs Directorate: oct.smd-dgp.bec@hc-sc.gc.ca
- Biologic and Radiopharmaceutical Drugs Directorate: brdd.cta-dec.dmbr@hc-sc.gc.ca
For details on processing CTAs and CTA-As, consult section 2.5 in:
During the 10-day processing period and depending on the type of submission or application, OSIP will:
- assign a control number
- enter the initial information into the drug submission tracking system (DSTS)
- for example, medicinal ingredient, dosage form, brand name, date received
- verify that the information submitted is administratively complete
- for example, the submission contains all necessary certification forms and the REP Product Information (PI) and REP Regulatory Transaction (RT) templates, including a completed fees section
- the information meets the requirements of section 5 of the Patented Medicines (Notice of Compliance) Regulations, where applicable
- verify that the data protection provisions in section C.08.004.1 of the Food and Drug Regulations do not prevent the filing of the submission
At this stage in processing, the information package may be placed on:
- Process Hold – Initial or
- Patent Form V Hold or
- Data Protection Refused Hold
When a submission or application in the Drug Submission Tracking System – Industry Access is placed in 1 of these 3 administrative holds, the filing date (previously referred to as “CR Date”) is not final.
Learn more about the different types of administrative holds.
When the hold is resolved or the information package is considered administratively complete, then the:
- information package becomes a submission or application
- filing date is entered into the DSTS
- remainder of the submission or application information is entered into the DSTS, if applicable, and
- appropriate review area is notified that the submission or application has been processed and can be assigned to a regulatory project manager (RPM) or senior regulatory affairs officer (SRAO) for screening
Cancellation or withdrawal letter during processing period
Sponsors who wish to cancel their submission or application during the processing period should send a signed letter requesting the cancellation to OSIP in the same format as the original submission or application. The status of the submission or application will be changed to “Cancel Admin” in the DSTS, as the scientific review has not started.
For CTAs and CTA-As, you should send a signed letter requesting the withdrawal of an application or amendment to the Office of Regulatory Affairs in the Biologic and Radiopharmaceutical Drugs Directorate (BRDD) or Office of Clinical Trials in the Pharmaceutical Drugs Directorate (PDD). The status of the application or amendment will be changed to “Withdrawn” in the DSTS.
Submissions and applications that are cancelled or withdrawn do not affect a refiling.
For more information, refer to the following sections:
Submissions and applications for administrative processing
Submissions and applications for administrative processing are to be submitted to Health Canada when the manufacturer's name or product name has changed due to a merger, buy-out, other corporate restructuring or when establishing a new licensing agreement.
They may be processed administratively, only if the original cross-referenced drug product has received market authorization from Health Canada and has an active drug identification number (DIN).
These types of submissions and applications may be filed for:
- NDSs and ANDSs, including their applicable supplements
- NCs (quality changes for biologics and radiopharmaceuticals) and
- applications for a DIN and post-authorization Division 1 changes, such as:
- PDCs for prescription, non-prescription and disinfectant products
- PDC-Bs
To be eligible for administrative processing, these submissions and applications should not contain scientific data or require regulatory review. All aspects of the product, except for the manufacturer and product name, must be identical to those previously authorized for that product. Any deviations from the previously authorized product are not accepted under the administrative pathway.
For more information on administrative processing, consult:
Solicited information in a clarification request should be submitted within 5 business days from the date of the request. If the response to a clarification request is not satisfactory or not submitted within the specified time, Health Canada may send a:
- deficiency notice (response should be submitted within 45 days from the date of the request) or
- rejection letter
Screening
During the screening 1 period
The screening period begins when the submission or application is received at the relevant centre, bureau or office.
The RPM or SRAO will:
- verify that the type and class of the submission or application has been filed correctly given the intended purpose
- ensure requisite information for the type and class has been provided and
- verify the fee is appropriate
Note: In the Natural and Non-prescription Health Products Directorate (NNHPD), label reviewers also conduct the screening of some submissions.
Screening 1 period performance standards
For information on the screening process of CTAs and CTA-As, consult section 2.5.1 in:
Cancellation letter
Sponsors who wish to cancel their submission or application during the screening period before it has been accepted into scientific review should send a signed letter requesting the cancellation to OSIP. It should be in the same format as the original submission or application. The status of the submission or application will be changed to “Cancel Admin” in the DSTS, as the scientific review has not started.
The SRPM or SRAO will issue the cancellation acknowledgment letter.
Submissions and applications that are cancelled by the sponsor do not affect a refiling.
For more information, refer to the following sections:
Screening acceptance letter
If the information submitted by the sponsor is acceptable at screening and requests for information or clarification are not required, then the:
- submission or application or response to solicited information is accepted for scientific review and a screening acceptance letter (SAL) is sent to the sponsor
- appropriate databases are updated and
- relevant review division is notified
Once the submission or application is accepted for scientific review, the RPM or SRAO continue to be the sponsor’s point of contact.
Solicited information
Solicited information during the screening process is any information that Health Canada requests during the screening of a submission or application. Examples include clarification requests and screening deficiency notices.
For information on the screening process of CTAs and CTA-As, consult section 2.5. 1 in:
Clarification requests during the screening 1 period
A clarification request is issued when Health Canada wants a sponsor to expand on, clarify or re-analyze information in the submission or application during the screening period. For example, a clarification request could be made to locate misplaced documents.
A clarification request should not be made to request missing documents or data, or new data, such as new clinical or pre-clinical information, bioavailability studies or chemistry and manufacturing data not previously submitted.
Health Canada will email the request. Sponsors must respond in writing. The screening process does not stop if we receive a complete response within the requested timeframe.
Response to a clarification request during the screening 1 period
When responding to a clarification request, sponsors should clearly identify in the cover letter the:
- name of the drug
- dossier ID
- control number of the relevant submission or application and
- purpose of the correspondence
- for example, “response to a screening clarification request”
Submit your response in a question-and-answer format and reference the applicable sections in the submission or application.
For acceptable formats, refer to the appropriate section in Filing submissions electronically:
- Preparation of regulatory activities in eCTD format
- Preparation of regulatory activities in non-eCTD format
For questions on filing submissions or applications electronically, you may contact BFMD.
Submit the solicited information within 15 calendar days from the date of the request or as indicated in the clarification request. A response is complete if:
- all clarifications or questions identified in the clarification request have been addressed or
- the sponsor provided a sound scientific rationale as to why the requested information is not necessary
Note: The duration that a sponsor has to respond to a clarification request does not include the day that the clarification request is issued. It does include all other days, including weekends and statutory holidays. For example, if a clarification request is issued on April 1 and you have 15 calendar days to respond, the deadline to submit the request is April 16.
For submissions and applications that are administratively processed, you should submit information solicited in a clarification request within 5 business days from the date of the request.
If a clarification request is inquiring about the location of data in the submission or application, you should only include the location of the data or an explanation as to why the data is missing.
To clarify any items in the clarification request or the reason for issuing it, you should contact the RPM or SRAO.
There is no limit on the number of clarification requests that may be solicited for 1 submission. However, a particular issue will only be addressed once. Acknowledgement letters are not sent when we receive information in response to a clarification request.
During the screening of a submission or application, if a response to a clarification request is not satisfactory or is not submitted within the specified time to respond, we will send a deficiency notice or rejection letter for administrative processing. For all other submission or application types, we will send a screening deficiency notice.
Screening deficiency notice
If deficiencies are identified during the screening of material relating to a submission or application, we will send the sponsor a screening deficiency notice (SDN) identifying the deficiencies. This may also include submissions where the drug is filed as a DIN application but is considered a new drug or where the monograph attestation does not reflect the submission content. The status of the submission or application will change to “inactive 45” in the DSTS. An SDN may be sent to the sponsor without a clarification request having been issued.
The solicited information is to be submitted within 45 calendar days from the date the SDN was sent.
To clarify any items in the SDN or the reason for issuing it, you should contact the RPM or SRAO.
Response to screening deficiency notice
When responding to an SDN, you should clearly identify in the cover letter the following:
- name of the drug
- dossier ID
- control number of the relevant submission or application and
- purpose of the correspondence (for example, “response to SDN”)
Your response should be in a question-and-answer format and referenced to the applicable sections of the submission or application. It should not contain unsolicited information unless otherwise specified in the SDN.
Refer to the section on unsolicited information.
You should send all requested information along with the up-to-date documents and an updated cover letter in a single package to OSIP for processing. OSIP will process this information and send to the appropriate review area within 10 calendar days. When OSIP begins to process the response to the SDN, it will change the status of the submission to “process” in the DSTS. If the response is administratively incomplete, it will change the status to “Process Hold”.
Once OSIP verifies that the response is administratively complete, it will notify the RPM or SRAO that it has processed the response.
Acknowledgment letters are not sent when responses to SDNs are received.
When the information requested in the SDN is received at the relevant centre, bureau or office, a new screening 1 period begins (with the associated performance standards). The requested material and information will be screened to ensure it is complete.
Acceptance letter following the response to a screening deficiency notice
If the response to the SDN is acceptable, a screening acceptance letter (SAL) is sent to the sponsor. The review 1 period begins immediately.
Screening rejection letter
A screening rejection letter (SRL) is issued by the SRPM or SRAO. (Note: In NNHPD, the SRPM, SRAO or manager issue screening rejection letters.) This is done when a sponsor does not provide a response to the SDN within 45 calendar days or if the information is incomplete, deficient or contains unsolicited information. An SRL instead of an SDN is sent for a notifiable change (NC), supplement to a new drug submission (SNDS) or supplement to an abbreviated new drug submission (SANDS)if the proposed changes are Level III changes only.
For more information, consult the following guidance documents:
- Post-notice of compliance (NOC) changes: Safety and efficacy document (for pharmaceutical, biologic and radiopharmaceutical drugs for human use only)
- Post-notice of compliance (NOC) changes: Quality document
To clarify items in the SRL or the reason for it being issued, you should contact the RPM or SRAO.
If an SRL has been issued, you may: