Health Canada Announces Good Manufacturing Practices Inspection Database

On April 13, 2015, Canada’s Health Minister, announced the launch of Health Canada’s Good Manufacturing Practices (GMP) inspection database. This announcement is aimed at increasing the transparency of the pharmaceutical regulatory process.

The GMP inspection database provides Canadians with information on Health Canada’s findings on inspections of pharmaceutical manufacturers. The database provides information on both foreign and domestic drug inspections conducted since 2012.

Canadian media have recently been very critical of Health Canada after theStar discovered that certain drugs manufactured in India that were destined for North America were banned by the United States Food and Drug Administration from being sold in the US market, but Health Canada continued to allow the sales of the same drugs in Canada.

While launching the GMP inspection database may be a step in the right direction, some practitioners and consumers may think that the next step should be the implementation of legislation mandating that certain specific information be made available to the Canadian public. This kind of legislation may help avoid ambiguity in Health Canada’s reports, such as vaguely citing “data integrity concerns”, as was the case in a recent alert provided by Health Canada for three facilities in India.

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Pharmaceutical Microbiology