November 24, 2021 | Ottawa, ON | Health Canada
Health Canada has completed its onsite inspection of the Emergent BioSolutions facility in Baltimore, Maryland. The European Medicines Agency and South African Health Products Regulatory Authority also participated in this inspection remotely. All three regulators found the facility to be compliant with Good Manufacturing Practices (GMPs).
GMPs are an internationally recognized quality assurance system used to ensure that drugs and vaccines are made, packaged, labelled, tested, stored, imported and distributed using consistent standards.
In June 2021, Health Canada communicated that Canada would not accept any product or ingredients made at the Emergent BioSolutions facility until the Department completed an onsite inspection. This facility manufactures the drug substance used in some doses of the Janssen (Johnson & Johnson) COVID-19 vaccine.
Health Canada’s compliant rating means that Janssen Inc. will be able to import their vaccines into Canada that are made with the drug substance manufactured at the Emergent BioSolutions facility.
While there are no further shipments of the Janssen vaccine planned at this time, the Government of Canada will continue working with provinces and territories to identify any further doses that may be required. As with all vaccines, each lot of the Janssen COVID-19 vaccine that could potentially be imported into Canada or donated on Canada’s behalf will be assessed to confirm that it meets Health Canada’s stringent safety and quality requirements. Only vaccine lots that meet these requirements will be released onto the Canadian market or provided as a Canadian donation.
The shipment of Janssen vaccines that Canada received on November 10 came from compliant manufacturing sites in Europe.