Health Canada’s latest update of its risk classification document is actually no more than a change of font.
Last week, in-PharmaTechnologist.com reported the publication of an update to Health Canada's GUI-0023 guidance document .
The agency said that the document was intended to "classify the observations noted during establishment inspections according to their risk," "ensure uniformity among the inspectors of the Health Products..." and "inform the industry of the situations that the Inspectorate considers unacceptable."
However, during a subsequent interview with a spokesman for the authority, we found that the changes were in fact part of the Canadian Government's efforts to develop a "common look-and-feel standard" for its websites.
Rather than simply pull the article - which was shared extensively on social media channels - we decided to ask Health Canada why it had not included a disclaimer explaining that the changes related to fonts rather than issues that could cost manufacturers millions of dollars.
In response the organisation said: “There have been no changes to the risk classification process used by Health Canada inspectors during good manufacturing practice (GMP) inspections. In 2012, GUI-0023 was updated to adhere to the Government of Canada's ‘common look-and-feel standard’ for posting on the Health Canada website.
The organisation explained the changes were to the font, font size, document width, bookmarks, hyperlinks within the document and hyperlinks to referenced web documents and told us “we understand the circumstances that led to the article in your publication.”
What do you think?
At the time of publishing this article, the guidance still included no indication what-so-ever that the changes made were simply typographical, not regulatory.
Should the regulator make updates more clear? Is it irresponsible to leave a misleading update on the website? Do you feel changes made should be reviewed by top ranking seniors?
Have your say with in-PharmaTechnologist.com’s quick anonymised poll.