Health Canada publishes comparative analysis of fees for regulated products
Canada
May 12, 2023
Health Canada's regulatory regime is not directly comparable to those of other countries. It is important to know how other regulators treat natural health products (NHPs) when establishing a cost recovery regime in Canada.
Health Canada looked at 4 regulators:
- European Medicines Agency (EMA) (English only)
- Australia's Therapeutic Goods Administration (TGA) (English only)
- United States' Food and Drug Administration (U.S. FDA) (English only)
- United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) (English only)
| Health Canada (proposed) | Australia/TGA | United Kingdom/MHRA | European Union/EMA | United States/FDA | |
|---|---|---|---|---|---|
| Product classification |
Class I, II, III Separate from drugs or foods |
From listed (low risk), assessed listed, to registered (high risk) medicinesFootnote1 | From dietary supplement to prescription medicine | From food supplement, herbal medicine, to drug | From dietary supplement to drug |
| Product licensing fee | $1,124 to $58,332 |
Listed and assessed listed products: $1,229 CAD ($893 + $451 AUD) Registered products: $38,433 CAD ($3,047 + $38,988 AUD) |
$856 CAD (£517) to $8,290 CAD (£5,006) (homeopathic to new drug application) | $0 to $449,520 CAD (€313,200) (marketing authorization application) | $0 (up to $823,706 CAD or $633,620 USD for comparable productsFootnote2) |
| Annual product fee | $542 |
$1,094 CAD ($1,200 AUD) to $1,440 CAD (1,580 AUD) |
$126 CAD (£76) to $4,021 CAD (£2,428) based on product classification (periodic homeopathic/herbal to standard) | $0 to $161,035 CAD (€112,200) based on product classification (maintenance of a marketing authorisation) | N/A |
| SL fee | $4,784 |
Initial fee of $766 CAD ($841 AUD) + variable inspection cost (manufacturing licences) |
$303 CAD (£183) to $5,205 CAD (£3,143) (NOPFootnote3 to standard licence application) | $34,015 CAD (€23,700) + variable inspection cost | $21,921 to $32,880 CAD ($16,119 to $24,178 USD) (monograph drug facility fee)Footnote4 |
| Annual site fee | $6,921 to $40,071 |
$4,507 CAD ($4,945 AUD) (annual charges for manufacturing licences) |
$775 CAD, (£468) (periodic manufacturing licence) | Up to $31,575 CAD (€22,000) (from Ireland) (annual fee major site) | |
| Fee reduction |
First NHP product application free for small business, 25% to 50% reduction thereafter 25% to 50% reduction also applies to SL applications and amendments and right to sell |
Annual product fee deferred until product sold on market 50% annual licence fee reduction for small businessesFootnote5 |
25% to 50% fee reduction for small business and payment deferralsFootnote6 | 40% to 100% fee reduction for micro and small businesses,Footnote7 orphan drug fee reductions and payment deferrals for inspection and marketing authorizationFootnote8 |
For further information (in English), click on the Link
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