Articles

Consultation on Upcoming Changes to NHP Labelling Regulations

Consultation on Upcoming Changes to NHP Labelling Regulations

The Natural and Non-Prescription Health Product Directorate (NNHPD) at Health Canada recently released a draft guidance document pertaining to potential upcoming changes to the current Natural Health Product (NHP) regulations published in Canada Gazette, Part I. These...

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UPDATED Health Canada Acne Therapy Monograph

UPDATED Health Canada Acne Therapy Monograph

The Health Canada Acne Therapy Monograph was updated on Jun. 25, 2021 to include specific acceptable dosage forms for both non-prescription drugs and Natural Health Products (NHPs) as well as an additional Directions for Use statement for aerosol and spray acne...

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Tighter Restrictions to be implemented for Talc

Tighter Restrictions to be implemented for Talc

The Government of Canada conducts risk assessments of substances under the Canadian Environmental Protection Act, 1999 (CEPA) to determine whether they present or may present a risk to human health or to the environment. A final risk assessment was recently completed...

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FDA OTC MONOGRAPH DRUG USER FEE RATES FOR FISCAL YEAR 2021

FDA OTC MONOGRAPH DRUG USER FEE RATES FOR FISCAL YEAR 2021

In March 2020, provisions were added to the Federal Food, Drug, and Cosmetic Act by the Coronavirus Aid, Relief, and Economic Security (CARES) Act, which authorize FDA to assess and collect user fees from qualifying manufacturers of OTC monograph drugs and submitters...

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Phase I of the Self-Care Framework

Phase I of the Self-Care Framework

Health Canada has announced that there will be updates to the approach to regulating self-care products as part of their 2020-2022 Forward Regulatory Plan. The self-care framework will roll out in phases over the coming years: Phase I – Target Spring 2021 will include...

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