Preclearance Procedure & Operations

Transcription

1 Preclearance Procedure & Operations Helpful pointers about the submission process Malika Ladha PAAB Reviewer 1

2 PAAB Submission Procedure Key Steps in PAAB Approval Process General Timelines and services available Tips to save time! How submission errors impact timelines Reasons for having files returned When should files be separated/submitted as separate efiles 2

3

4 Key Steps in PAAB Approval Process Available Services Pre Submission General Questions Opinion Requests Billable Meetings

5 General question: Questions which relate to the PAAB Code or PAAB guidance documents in a general way These calls are not are related to a specific product or ongoing file Reviewers return calls within 1 business day and call should take no more than 5-10 min

6 Opinion Requests: Written opinion service with response sent within 4 business days Examples: To clarify exemption from review To receive guidance on acceptability of concepts To receive guidance on the acceptability of references for product claims To clarify linkage of material

7 Billable Meetings: Opportunity to share information with reviewers who work within the relevant therapeutic area To obtain preliminary feedback on your planned messaging One hour meetings

8 Key Steps in PAAB Approval Process Create a Complete Submission! PAAB receives submission Cover Letter Regulatory Documents (PM, NOC) References Copydeck Information Architecture Do not submit separate projects within the same efile

9 Cover letters Every new submission should be accompanied by a cover letter What documents have been included in the submission Describe how the tool will be used (i.e. rep directed or HCP driven tool) Is it a renewal? Provide previously approved efile # Is there pick up from previously approved efiles? Identify any special considerations

10 Regulatory Requirements Product Monograph (PM) Most current Submission control must match on PM & Letter Health Canada approval letter NOC, NOL NOC - Notice of Compliance, NOL - No objection Letter

11 Annotated PM An annotated PM highlights all additions and deletions made

12 Annotated PM With each new submission for the first 3 months after notifying PAAB of the change For renewals if PM updated since APS accepted PM update during an ongoing review may incur a new file # and fee

13 English Copy Copydeck (and/or layout) format used for the initial submission should be maintained for the duration of the review process finalized before submitting to PAAB Shouldn t be any to-be-determined elements Multiple options for any copy Medical Regulatory must have signed off on piece prior to submitting Identify previously approved copy Reference all claims

14 Copydeck: Referencing Each claim or presentation should be clearly referenced. Clear identification of the reference source, page number and section of the page Don t just cite the source s (5-7) References appear in a different colour from the advertising copy

15 Copydeck: Referencing Clearly identify the reference source, page number and section of the page Example: Ref 1A, p. 151 Source Ref 1 Section on the page (highlighted) - A Page # - p.151 Example: Based on efile 31223

16

17 References The corresponding section(s) of the reference should be highlighted and labeled

18

19 Electronic Tools Include the information architecture (i.e. sitemap, storyboard) Flow of information

20 Summary: New submission requirements Cover letter Product Monograph & NOC/NOL Copydeck (finalized) References Information architecture Do not submit separate projects within the same efile

21 Do not submit separate projects within the same efile Examples: - Downloadable resources in an website: - More than one regulatory audience - One website for two different products - E-detail aids with different flows - Short call vs. long call

22 Key Steps in PAAB Approval Process Assignment of submission to reviewer

23 Key Steps in PAAB Approval Process Reviewer sends PAAB letter e.g. evidence to support that a visual conveys the severity of the disease that falls within the limitations of the indications

24 Key Steps in PAAB Approval Process Clarification Calls: If the client does not understand the PAAB review comment Clarification calls with reviewer Escalation Calls: When? After receiving a PAAB letter about the same issue which was discussed on the phone with the reviewer Who? Deputy Commissioner Reviewer Client and Manufacturer

25 Key Steps in PAAB Approval Process Tips when responding to PAAB letters: Client submits revised APS Include the following: Itemized response letter Highlight revisions (solicited & unsolicited) Identify unsolicited changes in response letter Provide highlighted references

26 Preclearance Procedures

27 Key Steps in PAAB Approval Process Acceptance number provided

28 File submitted for review & assigned to reviewer 5 days Annotated TMA was not submitted, file sent back as incomplete File resubmitted to PAAB 10 day clock resets 6 days File resubmitted to PAAB with revisions PAAB sends 2nd response letter PAAB sends 1st response letter 3 days

29 File resubmitted to PAAB with revisions 3 days File resubmitted to PAAB with revisions 2 days 2 days PAAB sends 3rd response letter (unsolicited revisions) English acceptedrequest French copy File Approved Total PAAB Time = 21 days French copy submitted for review

30 File submitted for review & assigned to reviewer 5 days Annotated TMA was not submitted, file sent back as incomplete File resubmitted to PAAB 6 days File resubmitted to PAAB with revisions PAAB sends 2nd response letter PAAB sends 1st response letter 3 days

31 File resubmitted to PAAB with revisions 3 days File resubmitted to PAAB with revisions 2 days 2 days PAAB sends 3rd response letter (unsolicited revisions) English acceptedrequest French copy File Approved TotalTotal PAAB PAAB TimeTime = 21=days 21 days 13 days French copy submitted for review

32 Submission Tips & Time Savers Make sure that new submissions are complete Provide back files Highlight all revisions (inform us of unsolicited changes) Highlight all references Ensure all APS elements are clear to PAAB (e.g. tags, popups, li ks ) right fro the i itial sub issio 6. Include a letter of response identifying all actions taken (or not taken) in response to PAAB comments 7. Consider if the content should be split into multiple files

33 Preclearance Procedures PAAB Resources Need Help? Guidance on Submissions APS Checklist Reference Checklist Mar_1_(002).pdf If in doubt, call us!

34 Questions?