"Sponsor Attestation Checklist for Abbreviated New Drug Submissions (Andss)" - Canada

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Sponsor Attestation Checklist for Abbreviated New Drug
Submissions (ANDSs)
Health Canada Use Only
Dossier ID
Control Number
Date/ Time of Receipt
Sponsors should address the points outlined below by answering “Yes”, “No”, or “Not Applicable”,
providing a justification where required, and completing the requested information. This Sponsor Attestation
Checklist is not required for Supplemental Abbreviated New Drug Submissions (SANDSs) or Labelling Only
submissions.
Comment boxes have been provided to allow sponsors to add notes to reviewers where relevant. If the
product includes more than one Drug Substance, sections S.1-S.7 should be answered for each Drug
Substance.
Introduction
Do you wish to receive communications from Health Canada regarding this submission electronically (e.g.
via email)
?
Yes
No
Proposed Product:
Canadian Reference Product (CRP):
Brand Name:
Brand Name:
Drug Substance(s):
Drug Substance(s):
Company Name:
Company Name:
Dosage Form(s):
Dosage Form(s):
Strength(s):
Strength(s):
Protected when completed
Sponsor Attestation Checklist for Abbreviated New Drug
Submissions (ANDSs)
Health Canada Use Only
Dossier ID
Control Number
Date/ Time of Receipt
Sponsors should address the points outlined below by answering “Yes”, “No”, or “Not Applicable”,
providing a justification where required, and completing the requested information. This Sponsor Attestation
Checklist is not required for Supplemental Abbreviated New Drug Submissions (SANDSs) or Labelling Only
submissions.
Comment boxes have been provided to allow sponsors to add notes to reviewers where relevant. If the
product includes more than one Drug Substance, sections S.1-S.7 should be answered for each Drug
Substance.
Introduction
Do you wish to receive communications from Health Canada regarding this submission electronically (e.g.
via email)
?
Yes
No
Proposed Product:
Canadian Reference Product (CRP):
Brand Name:
Brand Name:
Drug Substance(s):
Drug Substance(s):
Company Name:
Company Name:
Dosage Form(s):
Dosage Form(s):
Strength(s):
Strength(s):
2 | Sponsor Attestation Checklist for Abbreviated New Drug Submissions (ANDSs)
Module 1 – Administrative and Prescribing Information
Administrative Information
1.2.3
Certifications and Attestation Forms
Does a valid Certificate of Suitability (CEP) issued by the European Directorate
Yes
No
for the Quality of Medicines and Healthcare (EDQM) exist for this Active
Pharmaceutical Ingredient (API) and manufacturing site/process?
If “Yes”, has the CEP, along with all annexes and attestations been filed in
Yes
No
section 1.2.3 according to the Guidance document:
Use of Certificates of
Not Applicable
Suitability as supporting information in Drug
Submissions?
1.2.5
Compliance and Site Information
Have the filing requirements in Health Canada’s February 10, 2017
Notice
Yes
No
Submission Filing Requirements – Good Manufacturing Practices (GMP)/ Drug
Establishment Licences
(DEL) been met, for all activities listed in the Notice?
Comments:
Have all batches included in the submission been manufactured and tested at
Yes
No
a Good Manufacturing Practices (GMP) compliant facility?
If No, provide location of discussion:
2017-10-30
3 | Sponsor Attestation Checklist for Abbreviated New Drug Submissions (ANDSs)
1.2.6
Authorization for Sharing Information
List Master File (MF) number(s) referenced in the submission:
Not Applicable
MF numbers:
Types (i.e. I – IV):
For the above MFs:
1. Have Letters of Access granting access to the MFs on behalf of the
Yes
No
submission sponsor been provided?
2. Are the MFs in order and up to date (e.g. fees paid)?
Yes
No
Comments:
Yes
No
If there is no MF referenced, and there is no CEP filed as per section 1.2.3, is
all information on the drug substance manufacturing process and controls and
Not Applicable
the drug product container closure system included in the submission?
1.2.7
International Information
Provide information on the product application filing and marketing status (Mkd
Not Applicable
= Marketed) of the proposed product in the following jurisdictions:
United States Food and Drug Administration (USFDA):
Filed
Mkd
European Union (EU):
Filed
Mkd
If filed in the EU, indicate applicable procedure:
Centralized
De-Centralized
Mutual Recognition
National
Switzerland’s Swissmedic:
Filed
Mkd
Singapore’s Health Sciences Authority (HSA):
Filed
Mkd
Australia’s Therapeutic Goods Administration (TGA):
Filed
Mkd
2017-10-30
4 | Sponsor Attestation Checklist for Abbreviated New Drug Submissions (ANDSs)
Has Foreign Review Information for any of the above jurisdictions been
Yes
No
provided?
Review reports (specify jurisdiction, if applicable:)
Other
If Yes, has the
Foreign Review Attestation and Summary of Quality
Yes
No
Differences: Subsequent Market Entry Products (Human Drugs)
been
provided?
Not Applicable
Module 3 - Quality
Drug Substance
S.1
General Information
Does the proposed active pharmaceutical ingredient comply with the
Yes
No
interpretation of “Pharmaceutical Equivalent” as per the Food and Drug
Regulations, and “Identical Medicinal Ingredient” as described in Health
Canada’s policy Interpretation of “Identical Medicinal Ingredient” (2003) and
notice Interim Policy on Health Canada's Interpretation of Medicinal Ingredient
(2015)?
S.4
Control for the Drug Substance
a) Do any of the proposed limits for impurities exceed the applicable
Yes
No
International Council on Harmonisation (ICH) Qualification Threshold in
Q3A?
Not Applicable
b)
If “Yes” to a), specify the basis used for qualifying the impurity limits:
The limits are qualified in an official compendial monograph (specify:)
The limits are qualified in publicly available scientific literature (specify, and
indicate where in the submission this literature is located:)
Levels of these impurities are observed in the CRP
Limits are based on safety (e.g. toxicological) data (indicate where in the
submission the safety studies and discussion are located:)
Other (specify:)
2017-10-30
5 | Sponsor Attestation Checklist for Abbreviated New Drug Submissions (ANDSs)
Does the submission include a discussion of potential genotoxic impurities
(e.g. including the identification of potential structural alerts)?
Yes
No
Not Applicable
Location of discussion:
Have analytical results been provided for those batches used in non-clinical,
clinical, or comparative bioavailability studies (where applicable), and
Yes
No
comparative in vitro and stability studies?
If no, indication location of the justification:
If the scale of the batch is less than 1/10th commercial scale, has a justification
Yes
No
of why the smaller scale is representative been provided?
Not Applicable
Location of justification:
Have Certificates of analysis been provided for the pivotal batches?
Yes
No
Location of discussion:
S.7
Stability
Has the minimum amount of stability data (2 batches, minimum pilot scale, 6
Yes
No
months long term, 6 months accelerated) been provided as per ICH storage
conditions?
Have the requirements as of August 31, 2019 been addressed:
Yes
No
Has the minimum amount of drug substance stability data (6 months of stability
data on at least three pilot scale batches (at least 10% of commercial scale
and representative of the commercial process) or two pilot scale batches and
one small scale batch (if justified as representative of the commercial process))
been provided as per ICH stability guidances?
If no, provide justification:
2017-10-30
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