On May 12, 2023, Health Canada alerted industry of a proposal to introduce cost recovery fees for Natural Health Products (NHPs). This proposal, initially released for consultation from May 12 […] Read More >>
In Canada, infant formulas and human milk fortifiers are regulated under the Food and Drug Regulations, Part B, Division 25 (B.25.019). Health Canada defines infant foods as food to be […] Read More >>
Health Canada’s ongoing efforts to update and revise its monographs continue with the release of Batch 2 for consultation. This marks another significant step in ensuring the accuracy and relevance […] Read More >>
A Natural Product Number (NPN) is an 8-digit number issued to a Natural Health Product (NHP), after an assessment, indicating its approval by Health Canada’s Natural and Non-Prescription Health Products […] Read More >>
The Canadian Food and Drug Regulations (FDR) have established regulations for Food for Special Dietary use (FSDU) as well as food for infants, covered under Divisions 24 and 25 of […] Read More >>
On Thursday, September 21, 2023, representatives from dicentra attended the CHFA Now’s Regulatory Forum in Toronto in order to stay informed and be able to provide our clients, prospects, and […] Read More >>
In the ever-evolving landscape of regulatory compliance for the natural health product (NHP) industry in Canada, recent developments such as Bill C-47 (refresher here) and the NHP GMP Inspection Program […] Read More >>
Definition of a Pregnancy Test A urine pregnancy test device is an In-Vitro Diagnostic (IVD) hormonal assay that measures the beta (β) subunit of Human Chorionic Gonadotrophin (hCG) levels in […] Read More >>
On May 12, 2023, Health Canada alerted industry of a new proposal to introduce cost recovery fees for Natural Health Product (NHP) regulatory activities in Canada. The proposal, open for […] Read More >>
As of March 21, 2023, the Natural and Non-prescription Health Product Directorate (NNHPD) began applying new refusal criteria against Site Licence (SL) and Foreign Site Reference Number (FSRN) submissions, as […] Read More >>
The ALR application due date for MDELs is April 1, 2023. If you hold a Medical Device Establishment Licence (MDEL), you must submit your completed ALR application before April 1. […] Read More >>
On December 22, 2022, Health Canada opened consultation on a proposal to amend the Quality (Chemistry and Manufacturing) Guidance: New Drug Submissions (NDSs) and Abbreviated New Drug Submissions (ANDSs). The […] Read More >>
On December 16, 2022, Health Canada issued a notice to stakeholders regarding their proposal to amend the regulations for Biologic Drugs (Schedule D drugs) in Division 4, Part C, of […] Read More >>
On December 17, 2022, Health Canada pre-published in Canada Gazette Part I, amendments to the Food and Drug Regulations (FDR). Health Canada is recommending new provisions for new drug submissions […] Read More >>
Health Canada is proposing new amendments to the Food and Drug Regulations and Medical Devices Regulations. Part of these amendments include “new provisions that enable the rolling review of a […] Read More >>
Health Canada is proposing expanding the Terms and Conditions (T&Cs) on Class II to IV medical device licences to support the life cycle approach for regulating medical devices. This is […] Read More >>
Monkeypox, the disease caused by the animal-to-human transmission of the Monkeypox virus, is a zoonosis of the Orthopoxvirus genus within the Poxviridae family. While appearing similar to smallpox, it is […] Read More >>
On July 20, 2022, Health Canada published amendments to the Food and Drug Regulations (FDR), introducing new regulations for supplemented foods as a category. These new regulations continue to protect […] Read More >>
New labelling requirements announced by Health Canada in Canada Gazette, Part II, Volume 156, Number 14 titled “Regulations Amending the Natural Health Products Regulations” have come into effect as of […] Read More >>
The cost to obtain an MDEL (Medical Device Establishment Licence) and MDL (Medical Device Licence) in Canada depends on the medical device’s classification. In this blog, we will break down […] Read More >>
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