Health Canada recently released the Good Label and Package Practices Guide for Non-prescription Drugs and Natural Health as part of the Regulations Amending the Food and Drug Regulations (Labelling, Packaging and Brand Names of Drugs for Human Use) – more
Health Canada
Court upholds Health Canada decision requiring additional information on certain Apotex drugs manufactured in India
The Federal Court dismissed Apotex’s application for judicial review of the Minister of Health’s decision to require additional information from Apotex as part of its submissions for certain drugs manufactured in India by Apotex affiliates.
Read the full update here
Health Canada releases draft guidance documents for consultation related to good manufacturing practices and drug establishment licensing
On January 18, 2017, Health Canada released five draft guidance documents for consultation relating to good manufacturing practices and drug establishment licensing. The consultation period is open until April 18, 2017.
Read the full update in Norton Rose Fulbright’s Pharma …
Health Canada releases revised guidance document on approval pathway for biosimilars (formerly “subsequent-entry biologics”)
Summary
Health Canada has revised its guidance document on the approval pathway for biosimilar biologic drugs (biosimilars). The headline change is in the name: Health Canada has retired the “subsequent-entry biologics” moniker. The revised Biosimilars Guidance Document also…
Sugar, Salt and Fat : the Usual Suspects Targeted by Health Canada’s Proposed Mandatory Front-Of-Package Labelling System
Health Canada is contemplating mandatory front-of-package (FOP) labelling for prepackaged foods high in “nutrients of public concern”, namely sugars, sodium and saturated fat. This is one of the key initiatives put forward by Health Canada as part of its Health…