17 June 2026Health Canada
Canada finalises expanded drug shortage and discontinuation reporting rules
Health Canada registered SOR/2026-96, Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Shortages and Discontinuation of Sale of Drugs and Medical Devices), finalising a proposal first consulted on in December 2024. The regulations were registered on 29 May 2026 and published in the Canada Gazette, Part II on 17 June 2026.
Market authorisation holders must post shortage information in both English and French on the designated website where a shortage exists, or is likely within six months, and within five days of making that determination. Discontinuations must be reported at least twelve months before sale ends, or within five days of the decision where that lead time is not possible.
The amendments also give the Minister power to request information where there are reasonable grounds to believe a shortage could present a risk of injury to human health, and to list specific lots or batches as eligible for extended expiration dating. Equivalent shortage obligations extend to medical device manufacturers and importers, with the device provisions phased in later.
Who this affects Drug market authorisation holders, establishment licence holders, and medical device manufacturers and importers selling into Canada. Particularly relevant to anyone dependent on a single manufacturing site or a single API source.
Read the official notice at Canada Gazette, Part II ›
4 March 2026Health Canada
First full rewrite of the NHP good manufacturing practices guide in a decade takes effect
Version 4.0 of Good manufacturing practices guide for natural health products (GUI-0158) came into effect on 4 March 2026, having been published on 4 September 2025. It replaces version 3.0, which had stood since December 2015.
The guide is restructured to follow the order of Part 3 of the Natural Health Products Regulations, with expanded guidance across most GMP topics and a clearer articulation of importer responsibilities. It covers specifications, premises, equipment, personnel, sanitation, operations, quality assurance, stability, record keeping, and additional requirements for sterile and ophthalmic products.
It applies across manufacturing, packaging, labelling, importing, distributing, storing and testing for the full range of natural health products, including homeopathic medicines. If your quality system was written against version 3.0, it is worth a gap review.
Who this affects NHP site licence holders and applicants, product licence holders, and every manufacturer, packager, labeller, importer or storage operator in the Canadian NHP supply chain — including foreign manufacturers supplying Canadian importers.
Read the official notice at Health Canada ›
11 February 2026US FDA
MoCRA cosmetic facility registrations reach their first biennial renewal
The FDA has updated its Cosmetics Direct submission portal, user guide and supporting materials to help cosmetic facilities meet biennial registration renewal obligations under the Modernization of Cosmetics Regulation Act.
Under section 607(a)(2) of the Federal Food, Drug, and Cosmetic Act, a registered facility must renew every two years, counted from the date of its own initial registration rather than a common industry date. The FDA’s worked example is a registration received on 20 February 2024 falling due on 20 February 2026. An abbreviated renewal is available under section 607(a)(5) where the registration information has not changed.
Because facilities registered in large numbers ahead of the July 2024 compliance date, 2026 is the first year the renewal obligation applies at scale. New portal features include registration status display, renewal dates and automated reminders. Product listings remain a separate, annual obligation.
Who this affects Cosmetic product manufacturers and processors with US-registered facilities, including facilities outside the United States that supply the US market, and the responsible person for each marketed cosmetic product.
Read the official notice at U.S. Food and Drug Administration ›
30 July 2026US FDA
FY2027 user fee rates published; generic facility fees keep a domestic and foreign differential
The FDA published its FY2027 fee rates under GDUFA and PDUFA in the Federal Register on 30 July 2026. The rates apply from 1 October 2026 through 30 September 2027.
Headline GDUFA rates: ANDA application $375,684; Drug Master File $109,899; API facility $39,680 domestic and $54,680 foreign; finished dosage form facility $230,033 domestic and $245,033 foreign; contract manufacturing facility $55,208 domestic and $70,208 foreign. Program fees are $1,927,291 large, $770,916 medium and $192,729 small business.
Under PDUFA, the FY2027 application fee is $4,600,753 where clinical data is required and $2,300,376 where it is not, with a prescription drug program fee of $416,857. The persistent domestic-versus-foreign facility differential is worth modelling before committing to an offshore manufacturing site.
Who this affects Any organisation planning an ANDA or NDA filing, holding a Type II Drug Master File, or operating or contracting with an API, finished dosage form or contract manufacturing facility registered for the US market.
Read the official notice at Federal Register ›
