Canada Wants Mandatory Reporting on Drug Shortages
The Canadian government plans to require mandatory reporting of drug shortages, in a move that will bring it in line with U.S. and European shortages policies.
Under proposed amendments to the country’s drug laws, drugmakers would have to report shortages and discontinuations on a public website at least six months before they are anticipated. For unanticipated situations, companies have two days after learning of a shortage or deciding to discontinue a drug to notify the website.
Drugmakers discontinuing a drug in Canada have 30 days to submit information on the product’s identification number, discontinue date and latest expiration date. The information — including product details, the reason for the action and the anticipated date when the drug would be available to meet demand — would be posted in English and French.
The proposed regulations differ somewhat from those of the FDA or European Medicines Agency. While those agencies have dedicated drug shortage offices to oversee industry reporting, Health Canada would contract with a third party to administer its shortages website.
The FDA’s and EMA’s requirements also apply broadly to drugs and biologics, whereas Health Canada would outline specific types of drugs subject to reporting.
Currently, drugmakers in Canada post information on shortages and discontinuances to a voluntary, industry-run website, www.drugshortages.ca. Complying with the mandatory reporting provisions would cost industry an estimated US $673,000 annually, the government estimates.
Comments on the proposed amendments are due Sept 2. The regulations would take effect six months after they are registered. Read the proposed regulation here: www.fdanews.com/6-15-Canada-Shortages.pdf. — Jonathon Shacat