In July of this year, the FDA announced new innovative approaches that demonstrate safety and efficacy for nonprescription drug products while expanding consumer access to more products. These innovative approaches […] Read More >>
Last summer, Health Canada implemented the Plain Language Labelling criteria for non-prescription products and has mandated that by June 30, 2021, all products must be compliant at the retail level. […] Read More >>
Health Canada’s Non-Prescription Drug Monograph Attestation Pilot has just ended, low success rate will result in revisions to the process. Health Canada initiated a Non-prescription drug monograph attestation pilot in […] Read More >>
December 8, 2015 Health Canada releases Policy and Monograph on Medicated Vapour products. Health Canada’s Medicated Vapour Products Classification Decision In December, Health Canada published a notice to the industry […] Read More >>
Health Canada’s New Advance Notice of Importation Process Pilot Offers More Convenience and Flexibility to Importers of Drugs, NHPs, and Cosmetics. As regulatory consultants for the U.S. and Canada, dicentra […] Read More >>
NNHPD released many updates recently including: changing the name of the Directorate, finalizing the 3 Class review system for NHPs, announcing a 6 month pilot program for NHPs that fall […] Read More >>
Health Canada Allows for OTC Use of 10 Naturally Sourced Ingedients An excerpt from the American Herbal Products Association Report by Anne Wilkie, Senior Regulatory Strategy and Policy Advisor dicentra Read More >>
Clara di Tella, BSc, Pharm. QA Regulatory Affairs Specialist, dicentra Inc. On November 24, 2011 the European Food Safety Authority (EFSA), the Food and Agriculture Organization of the United Nations […] Read More >>