New Canadian GMP Regulations on FDA’s Radar

Posted by on Jul 19, 2013 in Latest News | 0 comments

The US Food and Drug Administration has published a news release on its website, advising industry participants that Good Manufacturing Practices for the importation and wholesale of Active Pharmaceutical Ingredients (API) are set to come into effect in Canada on November 8th.

The FDA news release points out that “the regulations […] extend establishment licensing requirements to all API manufacturers, packagers, labelers, testers and importers. An establishment license will not be issued until the applicant has been assessed by Health Canada and found to be in compliance with GMP rules.”

The new regulation means to foreign suppliers of Active Pharmaceutical Ingredients, such as Paracetamol (Acetaminophen), Amoxicillin, Tetracycline, to Canadian pharmaceutical companies that they will have to apply for, and obtain Canadian Drug Establishment licenses.

Gurvey&Berry are in the process of obtaining a Drug Establishment License (DEL) and being fully GMP compliant before the set deadline.

For the fool text of the news release, follow this link (opens in a new window): http://fdanews.com/newsletter/article?issueId=16938&articleId=156695