Canada’s federal health department Health Canada has written to its licensed drug and active pharmaceutical ingredients (API) manufacturers worldwide reminding them of their regulatory responsibilities and obligations. The department plans to step up planned and unplanned inspections of facilities, with the aim of taking timely and appropriate action where needed.
The letter to license holders notes that recent inspections by Health Canada have recorded several issues related to traceability, vendor qualification, cleaning validation, data integrity, and packaging conditions. Health Canada has taken compliance and enforcement actions where needed.
Companies must demonstrate adherence to Good Manufacturing Practice (GMP) by ensuring that processes, systems, training and expertise of employees meet GMP regulations [1].
In October 2014, Health Canada announced import bans on two of Canadian generics maker Apotex’s facilities in India, and on one site belonging to IPCA Laboratories also in India [2]. The bans were put in place as a result of data integrity problems at the sites, which had been picked up by the US Department of Food and Agriculture (FDA). The problems raised serious doubts about the quality and safety of finished products and APIs produced at these sites. Canada’s Health Minister, Rona Ambrose, said that the ban would remain until the department was satisfied that the data integrity problems were resolved [3].
FDA and Health Canada joined forces at the start of 2014 to launch the Common Electronic Submissions Gateway. Drug companies will be able to use the gateway to send drug authorization data online using a special dedicated channel of FDA’s existing system [4]. Earlier this year the European Medicines Agency (EMA) announced plans to share assessments reports for generics with regulators in Canada and other regulatory agencies outside the European Union [4].
Health Canada plans to make more information publicly available about its compliance and enforcement efforts through its new Inspection Tracker [5]. The tracker will provide a snapshot of the potential health and safety issues Health Canada is tracking with companies that fabricate, package/label, test, wholesale, distribute or import drugs for sale in Canada.
References
1, Health Canada. Health Canada reminds drug manufacturers about the importance of good manufacturing practices (GMP) [homepage on the Internet]. 2015 Mar 18 [cited 2015 Mar 18]. Available from: www.hc-sc.gc.ca/dhp-mps/compli-conform/gmp-bpf/docs/notice-avis-ltr-obligations-eng.php
2. GaBI Online - Generics and Biosimilars Initiative. Canada bans imports from three API facilities in India [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Mar 18]. Available from: www.gabionline.net/Generics/General/Canada-bans-imports-from-three-API-facilities-in-India
3. GaBI Online - Generics and Biosimilars Initiative. FDA and Health Canada streamline drug submissions [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Mar 18]. Available from: www.gabionline.net/Policies-Legislation/FDA-and-Health-Canada-streamline-drug-submissions
4. GaBI Online - Generics and Biosimilars Initiative. EMA to collaborate with other agencies on generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Mar 18]. Available from: www.gabionline.net/Policies-Legislation/EMA-to-collaborate-with-other-agencies-on-generics
5. Health Canada. Inspection tracker: drug manufacturing establishments [homepage on the Internet]. 2015 Mar 18 [cited 2015 Mar 18]. Available from: www.hc-sc.gc.ca/dhp-mps/pubs/compli-conform/tracker-suivi-eng.php
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