Podcast
Questions and Answers
What is the primary purpose of a New Drug Submission (NDS)?
What is the primary purpose of a New Drug Submission (NDS)?
AND submissions require comprehensive clinical trial data similar to NDS submissions.
AND submissions require comprehensive clinical trial data similar to NDS submissions.
False
What does ANDS stand for?
What does ANDS stand for?
Abbreviated New Drug Submission
The review process for NDS submissions typically takes a total of _____ calendar days under standard review conditions.
The review process for NDS submissions typically takes a total of _____ calendar days under standard review conditions.
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Match the following submission types with their characteristics:
Match the following submission types with their characteristics:
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Which statement accurately describes the typical costs associated with NDS and ANDS submissions?
Which statement accurately describes the typical costs associated with NDS and ANDS submissions?
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The ANDS process allows for faster market entry for generic products.
The ANDS process allows for faster market entry for generic products.
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How long is the review period for ANDS submissions?
How long is the review period for ANDS submissions?
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A pre-submission meeting with Health Canada is _____ for NDS submissions.
A pre-submission meeting with Health Canada is _____ for NDS submissions.
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What is one of the main differences in data requirements between NDS and ANDS?
What is one of the main differences in data requirements between NDS and ANDS?
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Study Notes
Definition and Purpose
- New Drug Submission (NDS): Required for newly developed drugs that haven't received approval in Canada.
- Abbreviated New Drug Submission (ANDS): Utilized for generic drugs that are equivalent to existing, approved medications in Canada.
Information Required
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NDS Requirements:
- Must include extensive chemical and manufacturing data.
- Requires detailed pre-clinical and clinical trial data.
- Needs to provide comprehensive safety and efficacy results.
- A proposed product monograph must be included.
- Should outline a risk management plan.
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ANDS Requirements:
- Requires chemical and manufacturing data but less extensive than NDS.
- Must present bioequivalence studies comparing the generic drug to the Canadian Reference Product.
- A product monograph based on the Canadian Reference Product is necessary.
- Includes mock-ups of the product label.
Submission Process
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NDS Process:
- An optional pre-submission meeting with Health Canada is recommended.
- Involves submitting a complete NDS package.
- Includes a screening period by Health Canada.
- Followed by a review process, which may entail requests for additional information.
- Final decision results in a Notice of Compliance (NOC) or Not Satisfactory Notice (NSN).
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ANDS Process:
- Submission of a complete ANDS package occurs directly.
- Encounter a screening period by Health Canada.
- Generally, the review process is simpler than NDS.
- Possible assessment of comparative bioavailability is conducted.
- Concludes with a Notice of Compliance (NOC) or Not Satisfactory Notice (NSN).
Review Timelines
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NDS Standard Review:
- Screening period lasts 45 days.
- Review period takes a total of 300 calendar days.
- Overall total for standard review: 345 calendar days.
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NDS Priority Review (if granted):
- Shorter screening period of 25 days.
- Review period reduced to 180 calendar days.
- Total for priority review: 205 calendar days.
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ANDS Review:
- Also has a 45-day screening period.
- Review period is limited to 180 calendar days.
- Total timeline for ANDS review: 225 calendar days.
Key Differences
- Data Requirements: NDS demands a broader range of data including original clinical trials; ANDS focuses specifically on establishing bioequivalence.
- Review Complexity: Evaluations for NDS are more intricate and time-consuming due to the incorporation of novel drugs.
- Cost Implications: NDS submissions generally incur higher costs linked to the necessary research and development.
- Market Entry Speed: ANDS provides a quicker pathway for generic products to market following patent expiration of the corresponding innovative drug.
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Description
This quiz explores the fundamental differences between NDS and ANDS submissions to Health Canada. Participants will learn about the definitions, purposes, and the specific information required for each type of submission. Perfect for students and professionals in the pharmaceutical field.
