The organisation first mooted the idea of extending good manufacturing practice (GMP) laws to include APIs in September in a document published in the Canada Gazette, however it only began seeking industry feedback this week.
At present in Canada GMP only applies to dosage forms and ingredients that are deemed to be ‘high-risk.’ Standard APIs in contrast are not covered by GMP and instead their quality is assessed through testing before they are used.
Health Canada argues that because this testing “cannot eliminate all risks” or be applied retroactively, the rules need to be revised.
The plan is to “This proposal would extend the drug GMP requirements set out in the Food and Drug Regulations such that they apply to all APIs.
It would also “extend the drug establishment licensing (EL) requirements set out in the Food and Drug Regulations such that they apply to all AI fabricators, packagers/labellers, testers and importers.”
Health Canada suggested that extending GMP to APIs would “create a new record-keeping requirement to foster the traceability of AI from the original fabricator to the dosage-form drug manufacturer.”
The regulator suggested that the move would yield a financial benefit for the country.
“This proposal would provide a net benefit to Canadians, with a net present value (NPV) of about $35.6 million over 10 years. The quantified benefits relate primarily to costs savings to industry due to the removal of poor quality drug products at the AI stage instead of recalls at the dosage-form stage.”
It also believes that: “Industry is expected to incur minimal incremental compliance costs as the majority already complies with the international guideline for export purposes.”
The consultation period will run until January 5.