Post Approval Changes for Drugs in Canada
If you’ve received a Drug Identification Number (DIN) or Notice of Compliance (NOC) for selling your drug product in Canada, then that is definitely a cause for celebration. Now it’s smooth sailing until such time as you want to make a change to your drug product. There are two major types of changes you may be considering for your drug product; changes involving the manufacturing of the drug product/drug substance contained in your drug, and changes which address the safe use of your product.
Examples of post-approval manufacturing changes could be changes such as:
- a change in batch size for the drug product
- a change in manufacturing procedures for the drug product
- revisions to the final specifications of the drug product
Examples of post approval safety changes to your product may include:
- addition of a new route of administration for your drug product
- addition of a new strength for your drug product
- new drug interactions relevant to your drug product
Health Canada has posted on their website several guidance documents to assist license holders in interpreting Health Canada’s Food and Drug Regulations as they pertain to post-approval changes for drug products. The guideline entitled Post-Notice of Compliance Changes: Framework Document (1) and accompanying papers on quality or safety/efficacy changes impart some handy information and background on the recent direction Health Canada has taken with respect to changes to marketed drug products.
These guidance documents remove the ambiguity surrounding post-approval changes for drug products in Canada, and assist the license holder in identifying which applications and supporting documents may be required for changes to their drug products. In some circumstances a license holder may proceed to make changes to their product without pre-approval by Health Canada, however in other cases the manufacturer must await approval of the change before going ahead with the changes. Which category the change falls into will of course be dependent on the change itself. This strategy is consistent to international regulatory strategies (adopted in other worldwide locations such as the European Union and Australia) whereby an integrated approach to review based on scientific risk is the foundation for decision making and acceptance of post-approval changes to drug products.
