Under the new regulations, which take effect in November, the country’s drug establishment licensing (EL) requirements will also apply to all API manufacturers, packagers/labellers, testers and importers. In addition, a new record-keeping requirement aims to enhance the traceability of APIs from the original manufacturers to the dosage-form drug manufacturer.
These companies will need to include the following information on the container label or on other documentation accompanying the drug:
- The regulated party’s name, contact details, and EL number, if applicable;
- Whether it has fabricated, packaged/labelled, distributed, wholesaled or imported the drug;
- The date of that activity;
- The expiration or re-test date of the drug; and
- The lot number of the drug.
The Canadian government anticipates that the regulations will provide a net benefit of about $33.4 million over 10 years to Canadians, which will be primarily from cost savings related to the removal of poor-quality drug s at the API stage, rather than later drug recalls.
“The qualitative benefits relate primarily to better protection for Canadians from poor-quality drug products,” the government said. “Because Canada does not regulate API directly at present, there are no specific Canadian data available. Nevertheless, there is evidence to support API-related problems being responsible for an estimated 2%–8% of dosage-form recalls in this country.”
The government also indicated the need for such regulations as it’s “one of the last industrialized countries to implement GMP for API,” it said.
Canada also will now be able to reduce duplicative regulatory oversight, and allow its regulator Health Canada to reciprocate in international regulatory work-sharing with countries with which it has an MRA (Mutual Recognition Agreement), which includes a number of EU countries, Switzerland, Norway and Australia.
In addition, Health Canada will be able to take advantage of GMP inspections by these partner countries, while Canadian manufacturers will be able to leverage their compliance with Canadian requirements and inspection results from Health Canada.
In addition, companies will have a transition period to get ready for the new rules. Companies that manufacture, packages/label, test or import an API will be allowed to continue to do so without an establishment license as long as they submit license application by February 2014.
“This transition provision will ensure that regulated parties do not find themselves in a state of non-compliance solely due to any Health Canada administrative delays,” the government said.