Notice: Tablet Scoring of Subsequent-entry Pharmaceutical Products

March 28, 2017
Our file number: 17-103376-453

Pursuant to Part C, Division 8 of the Food and Drug Regulations (FDR) and of Division 1 of the FDR, this Notice is to inform sponsors of Health Canada's position with respect to tablet scoring of subsequent-entry pharmaceutical products.

This approach is intended to align with those international jurisdictions that allow score line configurations in subsequent-entry pharmaceutical products that differ with respect to the reference product so as to improve access for Canadians to safe and effective subsequent-entry pharmaceutical products.

Tablet scoring is commonly employed to facilitate division of a tablet into two or more equal portions. 

This Notice provides guidance to manufacturers of subsequent-entry pharmaceutical products wishing to have a score line configuration that differs from the reference product.

If the sponsor of a subsequent-entry pharmaceutical product proposes a scoring configuration that differs from the reference product, a justification should be included in the drug submission and should address, at a minimum, the criteria listed below.  This justification will be taken into consideration during the review of the drug submission.

  • The splitting of the tablet will not change the drug release characteristics, such as modified release products for which the control of drug release can be compromised by tablet splitting.
  • A score line is not being introduced for a subsequent-entry pharmaceutical product that contains a critical dose drug, as defined in Health Canada's guidance document Comparative Bioavailability Standards: Formulations used for Systemic Effects.
  • The split tablet should be safe to handle and not pose risk of unintended drug exposure.
  • The resulting dose provided by the split tablet for the subsequent-entry pharmaceutical product is supported by the labelling of the reference product.
  • The labelling of the subsequent-entry pharmaceutical product does not contain text that would imply that differences in scoring configuration have advantages over the reference product.

Please refer to Health Canada's Draft Guidance Document: Quality (Chemistry and Manufacturing) Guidance: New Drug Submissions (NDSs) and Abbreviated New Drug Submissions (ANDSs) for recommendations on the technical data that should be included in the drug submission to support the acceptability of a scored tablet.

Following receipt of a Notice of Compliance or a Drug Identification Number (DIN) for a subsequent-entry pharmaceutical product, changes to the score line configuration of the marketed product to one that differs from that of the reference product would require that manufacturers submit either a supplement to a drug submission or a DIN Application with justification and supporting data as described above.

For questions related to this Notice, please contact:

Bureau of Pharmaceutical Sciences
Therapeutic Products Directorate
Health Canada
Finance Building
Address Locator 0202A2
Ottawa, Ontario
K1A 1B9

Telephone: 613-941-3184
Facsimile: 613-957-3989

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