New Drug Submission Screening Form

For Scientific Screeners

Section A: Administrative Information

Product Name

File No

Screener

Sub Type
Sub. No.

Manufacturer info (Name, address, contact info)

Manufacturer Contact for this submission (name, address, contact info)

Consultant Information (Name, address, contact info) (If applicable)

Forms

Submitted
Y/N

Fee Form (or A = adjusted?)

Submission Certification

3^rd Party Authorization

Access Letter for DMF
(Indicate DMF number)

Dates of data
yyyy.mm.dd

LS / Vol.

Orig.
Data
rec'd

SDN sent

Resp. to SDN

SRN sent

Additional Data:

Submission Purpose:

Related Submissions:

Referenced Submissions:

Section B: Drug Product Information (From HC/SC 3011)

Active Ingredient(s)

Strength(s)

Standard

Dosage Form

Route(s) of Administration

Therapeutic Class.

Species

Package Size(s)

Food

Non Food

Indication(s)

Section C: GMP Status for Manufacture of Drug Product ONLY.

A copy of VDD's request and response from the GMP unit should be attached to the screening report.

Note: Submissions with GMP certificates that are close to expiring should be flagged by the Screening Officer and a status update request will be made by the MCED reviewer at the review stage.
(See Section 6.4.3)

Date requested (yyyy.mm.dd):

Date response received (yyyy.mm.dd):

Compliant? Y/ N. If Yes, then add date:
(yyyy.mm.dd)

Section D - Screening of Labelling Information:

Inner

Outer

Pkg. Insert

Indicate all package sizes received. Ensure there is a label for all sizes including package insert for all strengths submitted. Name, strength must match HC/SC 3011

Section E - Screening Checklist

Part I: Master Volume (Please check SOP for handling details)

ITEM

Y/N

ITEM

Y/N

Table of Contents

Language of Data
(English or French)

Patent Forms
(yyyy.mm.dd)

date received

date forwarded to OPML

Format & Pagination

Labels

Submission and Product Summary

General Legibility

Optional (Delete if not applicable)

Information Package for CFIA (if drug is intended for food producing animals):

See section 1.17 of SOP

Information Package for CFIA (for drug premix products):

See section 1.17 of SOP

Environmental data

See section 1.18 of SOP

Optional (Delete if not applicable)

AbNDS only (delete section if not applicable):

Canadian Ref. Product (CRP)

File No:

Active CRP DIN ? (Y/N)

CRP DIN #

Last CRP NOC

Waivers? (Y/N)

Item

Matches CRP?
(Y/N)

Item

Matches CRP? (Y/N)

CRP is the pioneer product?

Dosage Form

Route of Administration

Conditions of Use

Formulation

Strength

Pharmaceutical Equivalence Studies

Labels

Bioequivalence Studies

Withdrawal period? (food producing only)

Other considerations

Y / N

Formulation used in manufacturing identical in pharmaceutical studies and bioequivalence studies?

Full Residue studies? (Food producing only)

Summary of AbNDS (including justification of waivers if applicable - waivers can only be considered if pharmaceutical equivalence is established. See section C.08.002.1(c)(iii) of Food and Drug Regulations)

Part II: Manufacturing and Quality Control

Date Submitted yyyy.mm.dd

No. of Original Vol.

No. Of Dup.

6.3

DRUG SUBSTANCE

REF to NDS Guidelines

Submitted
Y/N

6.3.1 General information

Nomenclature pg 24

Structure pg 24

Physiochemical Properties pg 24

Ensure a standard has been declared and verify its status in the appropriate documentation ie. USP -

6.3.2 Method of manufacture

Manufacturer complete address pg 27

Manufacturing process and process controls pg 28

Control of Materials used in drug substance production pg 29

Control of critical steps and isolated intermediates pg 29

Certificate of analysis for each material used in manufacture of drug substance should be provided SOP

Process validation protocol and report. pg 30
Note: Essential for Sterile Products ONLY

Manufacturing process development pg 30

6.3.4 Impurities

Potential impurities pg 32

Actual impurities detected pg 33

Comparative Impurities / degradation profiles with CRP (2 lots min) (AbNDS only) SOP

6.3.5 Control of the drug substance

Specification pg 34

• From the site responsible for release testing ie. Drug Product Manufacturer and NOT supplier
• signed and dated by Drug Product Manufacturer (If the specs are too old (>3-5 years), confirm with company that they are still current)

Analytical procedures pg 35

• From the site responsible for release of drug substance
• Verify method code in specifications against analytical methods
• Schedule B compendial procedures are not necessary unless modified

Validation of analytical procedures pg 36

• from the site responsible for release

Batch analyses pg 37

• min of TWO CoA should be provided

6.3.6 Reference standards

Current CoA pg 38

• Source of reference standard should be clearly identified.

6.3.8 Stability data for drug substance

• Stability protocol and data should be provided for min THREE lots (if available)
• Proposed storage conditions and retest period should be clearly indicated.

6.4 DRUG PRODUCT REF to NDS Guidelines Y/N

6.4.1 Description of drug product pg 43

6.4.2 Pharmaceutical development pg 44

6.4.3 Method of Manufacture

Manufacturer's name and complete address pg 45

Formulae pg 45

Manufacturing process pg 46

• Master Production Documents from the site involved in production and packaging of the final product.
• Executed Production document for at least TWO lots of each strength.
• Information on each manufacturing stage.

Process validation pg 49

• Protocol with commitment to place first three commercial lots on process validation study
• data from validation study if available.

Control of excipients pg 51

• Current specification and CoA from the manufacturer of the drug product

6.4.4 Control of the drug product

Specifications pg 53

• Current, signed and dated by the sponsor (for release AND shelf life).

Comparative Impurities / degradation profiles with CRP (2 lots min) (AbNDS only) ---

Analytical procedures pg 58

• For each test method for each active ingredient listed in specification with validation protocol/report (must match)

Batch analyses: pg 59

• CoA for at least TWO lots
• Summary of batch information (table for clinical lots)

CoA for Canadian Reference Product (2 lots min) (AbNDS only) SOP

6.4.5 Packaging

• Specifications for each component.
• CoA from supplier of packaging material or Certification of Compliance to the specification.
• Drawing for each component with dimensions.

6.4.6 Stability

• Accelerated and long term studies
• Proposed storage conditions and retest period to correspond with those listed in HC3011
• Post approval protocol and commitment to place stability samples on post approval studies.

6.5 Drug Premixes REF to NDS Guidelines

Submitted
Y/N

6.5.1 Stability of medicated feed pg 69

6.5.2 Mixing studies pg 69

6.5.3 Premixes proposed for concurrent use (if applicable) pg 69

6.5.4 Feed assay validation pg 69

Summary For Chemistry & Manufacturing

Date Submitted yyyy.mm.dd

No. of Original Vol.

No. Of Dup.

Part III: ANIMAL SAFETY

REF to NDS Guidelines

Submitted
Y/N

7.1 Laboratory Animal Studies pg 72

7.2 Target Animal Studies pg 76

Note: Provide a summary of lab animal studies. Pay attention to what drug product was used in the Studies. Does it have the same formulation as that requested in the application? If not, is a justification for the discrepancy provided? If no specific details are provided concerning formulation, ask the company to provide clarification as to which pivotal studies are using the current proposed formulation.

If cross referencing other studies; provide a justification as to why these other studies are relevant. Include as much detail as possible. For example: check that the two studies used products with the same formulation, the same dose amount, the same dose frequency, the same indications for use, the same species. If uncertain of validity of findings, check with CED for confirmation.

Summary For Animal Safety

Periodic Safety Update Reports (PSURs)

Documentation submitted (Has the company been approved in other jurisdictions (Y/N))
If No, then the rest of the questions do not apply

Applicable Country (ies)

Approximate duration in jurisdiction

Have any PSURs been included in the submission?

Date Submitted yyyy-mm-dd

No. Of Vol. of Original

No. Of Dup.

Part IV Efficacy

Submitted
Y/N

8.2.4 Clinical Pharmacology Studies pg 82

8.2.5 Dose Determination Studies pg 83

8.2.6 Dose Confirmation Studies pg 84

Comparative bioequivalence with CRP (AbNDS only) ---

REF to NDS Guidelines

Note: Provide a summary of efficacy studies. Pay attention to what drug product was used in the Studies. Does it have the same formulation as that requested in the application? If not, is a justification for the discrepancy provided? If no specific details are provided concerning formulation, ask the company to provide clarification as to which pivotal studies are using the current proposed formulation.

If cross referencing other studies; provide a justification as to why these other studies are relevant. Include as much detail as possible. For example: check that the two studies used products with the same formulation, the same dose amount, the same dose frequency, the same indications for use, the same species. If uncertain of validity of findings, check with CED for confirmation.

For ABNDS ONLY: waivers are assessed on a case by case basis. CED should be consulted in all cases.

Summary For Efficacy

Date Submitted yyyy.mm.dd

No. of Original Vol.

No. Of Dup.

Part V Human Safety

REF to NDS Guidelines

Submitted
Y/N

9.1 Laboratory Animal Toxicity Studies

Subchronic Oral Toxicity Studies pg 87

Carcinogenicity Studies (if applicable) pg 88

Multigeneration Reproductive Studies (2 generations) pg 90

Teratogenicity Studies pg 91

Short-term Tests for Genetic Toxicity Studies pg 91

9.2 Microbiological Safety Studies (for antimicrobial products) pg 93

9.3 Residue Studies

Metabolism Studies in the Intended Species (Radiotracer studies) pg 101

Comparative Metabolism Studies in the Laboratory Animals pg 101

Analytical Methodology pg 102

Validation of the Regulatory Method (s) for Detection and Confirmation of Residues of Veterinary Drugs in Food pg 102

Drug Residue Depletion Studies (Field studies) (For AbNDS, abbreviated studies are required) pg 103

Drugs for Concurrent Use in Combination (if applicable) pg 107

Identical withdrawal times with CRP (AbNDS only) ---

Note: Provide a summary of studies and show how it applies to the submission request. Pay attention to what drug product was used in the Studies. Does it have the same formulation as that requested in the application? If not, is a justification for the discrepancy provided? If no specific details are provided concerning formulation, ask the company to provide clarification as to which pivotal studies are using the current proposed formulation.

If cross referencing other studies; provide a justification as to why these other studies are relevant. Include as much detail as possible and include justifications if data is not present. For example: check that the two studies used products with the same formulation, the same dose amount, the same dose frequency, the same indications for use, the same species. If uncertain of validity of findings, check with HSD for confirmation.

Summary For Human Safety

Section F - Fee Assessment

MCED

CED

HSD

TOTAL

Fees Charged
(eg. $100 Section 2, Item 3)

Total Per Review Stream

If fee is
> $10K

n/a if paid in full

10%
Screening

40% after acceptance for review

50% final

Summary Of Fee Assessment

For Administrative Screeners

Section G - Processing of Fees for Rejected Submissions

Rejected Submission - 10% of total fee is retained.

Amount to be retained:

Section H- Processing of Fees for Acceptance for Review

Received by VDD

• % of Total
• Customer Number
• SO Number
• Invoice Number and Payment Method
• Fees Received

For Acceptance for Review

A No Invoice (100% Paid)

B Invoice to equal 50%

Amount to be invoiced:

C Fee changed - amount owing > $10,000

Amount to be invoiced:

D Fee changed - amount owing < $10,000

Amount to be invoiced:

E Fee changed - credit > $10,000

Amount to be credited:

F Fee changed - credit < $10,000

Amount to be credited:

G Keyboard input (Additional paragraph regarding fees to be added to the acceptance for review letter. This additional info requires the letter to be signed by the screening officer)

Note: Attach the fee assessment verified/revised by the screening officer

Section I- Component Invoicing

Component invoicing required? If so, add applicable amount(s) to the tracking card.

CED

MCED

HSD

N/A

Amount

Amount

Amount

Section J - Acceptance for Review Processing

All data received to-date (see section A for details) needs to be routed to the following division(s) for Review:

CED

HSD

MCED

SKMD-SO

Submission purpose to be included in the Acceptance for Review letter

Additional paragraphs to be added to the Acceptance for Review letter. This additional info requires the letter to be signed by Screening Officer.

Additional notes for Submission Processing Clerk

Company Code - Check DPD. If code does not exist, send HC/SC 3011 Form to SIPD

Recommendation

Original screening comments (and Response to SDN comments if applicable)

SDN Response Screened by (if applicable):

Signature

Final Decision at Screening:

Accept for Review

Name:
Signature:
Date:

Reject at Screening

Name:
Signature:
Date:

Notes for Reviewer