by Sagarika Sharma | Apr 2, 2024 | Canadian Regulatory, Importation of NHPs, Natural Health Products
In May 2023, Health Canada proposed implementing cost recovery fees to enhance regulatory oversight and streamline the approval processes for NHPs. During the initial consultation period, Health Canada received 4,696 comments from submissions and 116 emails, including...
by Srishti Chaudhari | Mar 28, 2024 | California Cosmetic Regulations, U.S. Regulatory
California’s Cosmetic Fragrance and Flavor Ingredient Right to Know Act mandates the reporting of fragrance allergens when present in a rinse-off cosmetic product at a concentration at or above 0.01% (100 parts per million), or in a leave-on cosmetic product at a...
by Srishti Chaudhari | Mar 26, 2024 | OTC Drugs, U.S. Regulatory
The registrants of drug establishments or their authorized agents can now report through the updated application in the NextGen Portal. The FDA has issued a final guidance to assist the registrants of drug establishments in submitting reports to FDA on the amount of...
by Srishti Chaudhari | Mar 26, 2024 | California Cosmetic Regulations, U.S. Regulatory
California published an update to the Reportable Ingredients List under the Safe Cosmetics Program on January 19th, 2024, to ensure all products sold in California containing specific hazardous ingredients are disclosed to the California Department of Public Health...
by Srishti Chaudhari | Mar 25, 2024 | Canadian Quality Assurance, Canadian Regulatory, Medical Devices
The proposed amendments to the Medical Device Regulations (MDR) would allow Health Canada to impose Terms and Conditions (T&Cs) on Medical Device Establishment Licences (MDEL) at anytime during the licence lifecycle. This policy is drafted in order to provide...
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