by Jennifer P | Jul 13, 2021 | Canadian Regulatory, Natural Health Products, OTC Drugs
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...
by Jennifer P | Apr 29, 2021 | Canadian Regulatory, OTC Drugs
The deadline for the first step of Health Canada’s risk evaluation for the presence of N-nitrosamine impurities in Canadian human pharmaceutical, biological and radiopharmaceutical products was March 31, 2021. This deadline applied to Market Authorization Holders...
by Jennifer P | Apr 29, 2021 | Canadian Regulatory, Cosmetics, Natural Health Products, OTC Drugs
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...
by Jennifer P | Mar 29, 2021 | OTC Drugs, U.S. Regulatory
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...
by Jennifer P | Mar 12, 2021 | Canadian Regulatory, Cosmetics, Natural Health Products, OTC Drugs
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...
by Jennifer P | Mar 7, 2021 | Canadian Regulatory, OTC Drugs
The deadline for the first step of Health Canada’s new risk evaluation for the presence of N-nitrosamine impurities in Canadian human pharmaceutical, biological and radiopharmaceutical products is fast approaching. This new Health Canada requirement for all Market...
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