Notice: Consultation on proposed revisions to the Guidance Document: Management of Drug Submissions

October 25, 2018
Our file number: 18-114145-61

Health Canada is revising the Guidance Document entitled: The Management of Drug Submissions (MDSG). This document provides sponsors and Health Canada staff of the Therapeutic Products Directorate, the Biologic and Genetic Therapies Directorate, the Natural and Non-Prescription Health Products Directorate (Non-Prescription Drugs Evaluation Division), and the Marketed Health Products Directorate with operational direction and guidance regarding the way in which drug submissions, applications or post-market documents submitted to Health Canada are managed. Specifically, it outlines and describes the processes and procedures to be followed to ensure consistency and transparency in the management of information and material submitted by sponsors to Health Canada in accordance with the Food and Drugs Act & Food and Drug Regulations.

There has not been a major revision to the MDSG since 1993. The guidance is largely being updated to reflect current processes and procedures, and to provide additional information and references relevant to the filing of a submission or application. The information in the guidance is also being reorganised to mirror the process that submissions and applications, or post-market pharmacovigilance documents submitted to Health Canada follow.

In addition to the general updates noted above, Health Canada is proposing the following changes to the guidance, which require consultation:

1. Remove the sections relating to Update Notices (section 5.5.1 A) and Advance Notice Letters (section 6.4) as the Notice and Letter are no longer used given the objective of the Department to review within the performance target standards.
2. Remove the paragraphs regarding information which must be submitted within 180 days of the original submission under subsection (b) of Section 5.5.2 Unsolicited Information. This requirement is no longer needed as the submission of unsolicited final reports of ongoing safety studies within 180 days of the original submission rarely occurs, since a complete data package should be included in the submission at the time of filing. If completed studies show any negative safety findings or risk information, sponsors can submit this information at any time.
3. Amend the existing 15-day standard timeline for responses to clarification requests (section 5.5.1B) to account for the type of submission or level of clarification being requested. The change will bring greater predictability for sponsors as it allows for the response time to better reflect the type of submission/application under review. The proposed wording of the MDSG is as follows:
   
   

   Proposed

   Sponsors are requested to send their responses to clarification requests in accordance with the Guidance Document: Preparation of Drug Regulatory Activities in the Electronic Common Technical Document Format or the Guidance Document: Preparation of Regulatory Activities in the "Non-eCTD Electronic-Only^{Footnote 1}" Format, as applicable. The timeline to respond should be between 2 and 15 calendar days and will be based on the complexity of the request and the performance target of the submission. While the type of request should guide response times (see below), these are guidelines and can be adjusted.

   Table 1: Timelines

   180 - 300 day performance target	Within 15 days
   91 - 179 day performance target	Within 10 days
   0 - 90 day performance target	Within 5 days
   CTAs and CTA-As	Within 2 days

4. Add performance standards (for existing and new fee categories under Cost Recovery), where none previously existed for screening 2 and review 2 timelines. In addition, Health Canada is correcting the screening time for labelling only drug submissions to reflect the MDSG text. This change aligns the screening time across the labelling categories. The proposed performance standards are outlined below.

   Table 2: Proposed performance standards

   Submission	Performance Standards (in calendar days)
   Class	Screening 1(including response to NOD)	Review 1 (including response to NOD)	UF Review 1 (iteration 1)Footnote 2	Screening 2 Response to NON	Review 2 Response to NON	Review of Response to NOC/c-QN
   Clinical or non-clinical data only, in support of safety updates to the labelling	45	120	120	45	90	0
   Labelling Only (Drugs)	45	120	120	45	90	0
   Labelling Only Disinfectants	45	90	90	45	60	0
   Labelling Only Generics	45	120	120	45	90	0
   Labelling Only Division 1	45	120	120	45	90	0

Comments on the proposed changes outlined in this Notice will be taken into consideration and any revisions will be made prior to the finalization of the revised guidance. It is anticipated that the final guidance will be published in the winter of 2019 and will include:

• the final version of proposed changes consulted on via this Notice,
• the final pause the clock proposal (available for consultation on the Health Canada website), and
• any changes reflecting the proposed cost recovery framework (available on the Health Canada website), in particular a revised Appendix 3: Target Performance Standards for Drug Submissions and Applications Review that reflects updated performance standards and submission types.

Comments should be provided to Health Canada, preferably in electronic format, within 30 days of the publication of this Notice to:

Bureau of Policy, Science and International Programs
Therapeutic Products Directorate
Health Canada
Address Locator 3102C3
Holland Cross, Tower B
1600 Scott Street
Ottawa, Ontario
K1A 0K9

Telephone: 613-948-4623
Facsimile: 613-941-1812
E-mail: hc.policy.bureau.enquiries.sc@canada.ca