Health Canada NDS vs ANDS Submissions

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

• 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.

• 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

• 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).

• 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

• 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.

• 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.

• 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.