Regulatory Focus™ > News Articles > Health Canada to Increase GMP Inspections, Promises Greater Transparency

Health Canada to Increase GMP Inspections, Promises Greater Transparency

Posted 04 March 2015 | By Michael Mezher 

Health Canada to Increase GMP Inspections, Promises Greater Transparency

Health Canada says it is boosting its efforts to inspect pharmaceutical manufacturers, and promises to be more transparent with inspection results in the future.

The move comes in the wake of an ongoing investigation by The Toronto Star, which has uncovered cases of data manipulation and unreported side effects at manufacturers supplying products to Canada. The paper made these revelations after obtaining inspection reports from the US Food and Drug Administration (FDA). At the time of the paper's investigation, Health Canada did not publish similar inspection reports.

New Efforts

In an announcement, Health Canada says it will “increase the frequency of planned and unplanned inspections” of drug establishments, and reminds Drug Establishment License (DEL) holders of their responsibility to comply with current good manufacturing practices (GMP). Any company that wishes to “fabricate, package, label, distribute, import, wholesale or test a drug” in Canada is required to obtain a DEL.

To help increase transparency, Health Canada has posted a new tool to track inspections on its website. The inspection tracker lists manufacturers that have been flagged for risks by Health Canada, another regulator or by the companies themselves. The agency says that starting 1 April 2015, it will be posting summary reports of all GMP inspections it conducts.

These efforts are all part of Health Canada’s Transparency and Openness Framework, which was launched in 2014 to address criticisms that the agency is not transparent enough.

Health Canada’s Transparency Problem

Canada has recently had to address a number of issues related to the transparency of its regulatory system.

Prior to the Toronto Star report, Health Canada did not publicly disclose how many times it inspected certain manufacturers and only revealed “sparse details” of inspection results. The report also called into question the number of foreign inspections Health Canada carries out, saying that on average, the regulator only visits 10 foreign manufacturers per year. The quality of these inspections is also questioned, citing a case where a manufacturer passed a Health Canada inspection, before and after the same facility was cited by FDA.

Following the Toronto Star report, Health Canada published the results of the inspections it carried out between 2012 and 2014, revealing a number of previously unknown violations.

Other Transparency Issues

Health Canada has also been called out recently for its lack of transparency related to clinical trials and its decision process for drug approvals.

In 2013, the Canadian government announced the launch of a public database for authorized clinical trials. The database was seen as a step in the right direction, but was criticized for lacking enforcement mechanisms and not requiring the publication of results.

Health Canada currently publishes Summary Basis of Decision (SBD) reports, explaining the rationale behind the agency’s approval of healthcare products. While these reports are released for authorized products, the agency does not publish its considerations for yet-to-be-approved products.

 

Health Canada Letter


Categories: Regulatory News

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