Drug Inspection Database Now Public

Overview

Food and Drug Law
Food and Drug Regulatory LawIn 2015, Health Canada launched its new searchable drug inspection database providing public access to detailed report cards of Health Canada’s drug and health product site inspections.1

Food and Drug Regulatory Law

Three separate Health Canada drug inspection lists are viewable on the site: (i) drug inspections of Canadian sites, by date; (ii) drug inspections of Canadian sites that received non-compliant ratings, by date; and (iii) drug inspections of foreign sites, by date. Additionally, the database can be searched by fields including establishment name, rating, license status, and terms and conditions on license. Health Canada has uploaded details on the latest inspections as well as those conducted since 2012.

Key Takeaways: Some members of the industry have noticed growing scrutiny for drug inspections in 2015, particularly with respect to transparency, data integrity and the strengthening of Health Canada’s oversight of foreign sites. Although manufacturers have previously asserted that inspection data is confidential business information, the decision to publish this information is in line with the regulator’s ongoing efforts to improve transparency. Health Canada’s new practice of publicizing this information makes the management of inspection results an increasingly delicate exercise for manufacturers in the face of media or news outlets seeking to leverage this information.

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1 The database can be accessed at:  http://healthycanadians.gc.ca/apps/inspections/index-en.html

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