How these are written
Every statement in a briefing is taken from the instrument, its Regulatory Impact Analysis Statement, or the issuing authority's own guidance, and each briefing lists its primary sources. Where an obligation falls on some parties and not others, the briefing says which. Where a requirement is a common practice rather than something the instrument imposes, the briefing separates the two.
Corrections are dated and left visible on the page rather than made silently.
Published
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FD&C Act §582(a)(3)
FDA Extends the DSCSA Small-Business-Dispenser Exemption to November 27, 2027
An employee count taken on 27 November 2026 decides which pharmacies carry specified DSCSA relief for another year, and which tracing and verification duties continue to apply whatever that count shows.
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SOR/2026-110
Amendments to the Medical Devices Regulations (Establishment Licences)
What SOR/2026-110 changes for medical device importers, distributors and manufacturers, who each requirement applies to, and what the amended Regulations do not require.
The Regulatory Record
A briefing takes one instrument at a time. The Regulatory Record is the weekly companion: five items each Friday from Health Canada, the FDA and the EMA, each with the primary source and one line on what a registration holder has to do about it.
About OmniReg
OmniReg monitors regulatory change across Health Canada, the FDA, the EMA and other authorities, and prepares the resulting assessments as completed work product. Each assessment is reviewed and signed by a qualified reviewer before it is issued.
We will review your registrations against the preceding twelve months of regulatory change at no charge, and identify changes that appear to remain unactioned. To request a review, send a product list and the markets in which you hold registrations. No call is necessary.