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Please refer to Health Canada's Draft Guidance Document: Quality (Chemistry and Manufacturing) Guidance: New Drug Submissions (NDSs) and Abbreviated New Drug Submissions (ANDSs) for recommendations on the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
Address Locator 0202A2
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