Abbreviated New Drug Submissions ANDS

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Abbreviated New Drug Submissions (ANDS)

• PRA 700

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Guidelines

• Preparation of Drug Submissions Comparative
  Bioavailability Studies

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Abbreviated New Drug Submissions

• A manufacturer of a new drug may file an
  abbreviated new drug submission for the new drug
  where, in comparison with a Canadian reference
  product,
• a) the new drug is the pharmaceutical
  equivalent of the Canadian Reference Product
• b) the new drug is bioequivalent with the
  Canadian Reference Product , based on the
  pharmaceutical and, where the Minister considered
  it necessary, bioavailabilty characteristics

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Abbreviated New Drug Submissions

• c) the route of administration of the new drug is
  the same as that of the Canadian reference
  product and
• d) the conditions of use for the new drug fall
  within the conditions of use for the Canadian
  reference product
• Generally, all second or subsequent market
  entries and reformulated products which satisfy
  the above criteria for the ANDS format

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Canadian Reference Product

• A drug in respect of which a notice of
  compliance is issued pursuant to section C.08.004
  and which is marketed in Canada by the innovator
  of the drug

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Canadian Reference Product

• A drug, acceptable to the Minister, that can be
  used for the purpose of demonstrating
  bioequivalence on the basis of pharmaceutical and
  where applicable, bioavailability
  characteristics, in comparison to a drug referred

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Pharmaceutical Equivalence

• As stated in C.08.001, Pharmaceutical equivalent
  means
• A new drug that in, comparison with another drug,
  contains identical amounts of the identical
  medicinal ingredients, in comparable dosage
  forms, but that does not necessarily contain the
  same non-medicinal ingredients

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Bioequivalence

• A high degree of similarity in the
  bioavailabilites of two pharmaceutical products
  (of the galenic form) from the same molar dose,
  that are unlikely to produce clinically relevant
  differences in therapeutic effects, or adverse
  reactions or both

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Submission Presentation
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Submission Structure

• The Certification is to be signed by the senior
  executive officer of the manufacturer in Canada
  and the medical or scientific director of the
  manufacturer
• If the submission certification or any
  significant part of the certification was
  prepared by an agent authorized by the
  manufacturer, the submission certification must
  also be signed by that agent

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Submission Certification

• A Submission Certification must be presented
  according to the Section C.08.005.1. It is
  preferred that manufacturers use their letterhead

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Application Form

• The Drug Submission application form HPB 3011 for
  an ANDS, together with the Drug Submission
  Screening Form, except for the Chemistry and
  Manufacturing Component, must be signed, and
  presented in this section

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Declaration of Patent Status

• Using Forms available on the Website, at the time
  of application for a NOC all manufacturers of
  second or subsequent market entry products must
  submit a declaration with each application if a
  reference or comparison is made to a product
  listed on the patent register

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Table of Contents

• Any section not included in the submission should
  have its omission explained
• Each part of the submission should be clearly
  identified
• Each volume of the submission should have its own
  table of contents with the page number of each
  item specified

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Product Monograph

• The PM for a second and subsequent market entry
  products must provide information directly
  relevant to the safe and effective use of the new
  drug
• If a patient package insert is envisage, a full
  copy of the proposed text should be also be
  included

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Product Monograph

• Please note that the conditions of use for the
  new drug must fall within the conditions of the
  use of the reference product
• A Copy of the current labeling and PM for the
  reference product must be included in the
  submission
• Any differences between the PM must be annotated
  to supporting data

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Labelling

• A draft of every label to be used in conjunction
  with the new drug must be submitted
• Typewritten or other draft label copy is
  acceptable for review purposes

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List of Related Submissions

• Any submission that relates to the submitted drug
  and under which investigations reported in this
  submission were conducted, cited or incorporated
  by reference must be identified
• CTA, NDS
• ANDS S/NDS
• S/ANDS NC

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Non-Canadian Package Inserts

• If the drug has been marketed outside Canada, the
  applicant is encouraged to supply the following
  information
• Names of countries
• Dates of approval
• Foreign Summary basis of approval
• Monographs or package inserts

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Module 3 Chemistry and Manufacturing

• The information in this part of the submission is
  to be presented in accordance with relevant TPD
  guidelines and polices

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Module 2 Comprehensive Summary Bioequivalence

• This Part of the submission is pivotal in the
  review process
• It should provide a comprehensive, integrated
  summary of the overall content of information
• Comparability of the product with the Canadian
  reference product of proven safety and
  effectiveness under the proposed conditions of use

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Module 2 Comprehensive Summary Bioequivalence

• This should include a scientific rationale and
  justification for the study design used, the
  parameters assessed and the standards applied

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Module 2

• It must also, be cross-referenced to the
  supporting documents provided in Module 5

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Module 2

• If the submission involves only a solution for
  parental use, and the PM has been provided as
  described, and data concerning the pharmaceutical
  equivalency and characteristics of the
  formulation have been provided in the CMC portion
  of the submission, then no additional information
  is required

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Module 5 Clinical Studies

• This part of the submission should include a
  detailed description of each study performed to
  establish the relative bioavailability and
  therefore, bioequivalence of each formulation
• The reports should be based on raw quantitative
  and qualitative data