April 8, 2014, Health Canada implemented steps to become “more transparent and open with Canadians about regulatory decisions,” by announcing the publishing of drug safety reviews of Continue reading
On April 4, 2014, Health Canada released a revised product monograph guidance that will become effective on June 1, 2014. This revised product monograph guidance introduces new Continue reading
On April 3, 2014 at 12:00 EST Regxia Inc. launched its first corporate rebranding, encompassing a refinement of the company’s logo and a re-launching of the corporate websites. Regxia’s Vice President and co-founder Lori Steinhoff – de Munnik, RAC sees “Regxia Inc.’s rebranding and website re-launch as Continue reading
Canadian Government Introduces New Law to Protect Patients – 2013 Throne Speech Commitments on Mandatory Adverse Drug Reaction Reporting, Recalls and Accurate Labels Continue reading
Health Canada has implemented a pilot project concerning the implementation of Good Manufacturing Practices (GMP) requirements for active pharmaceutical ingredients (API).
This pilot affects Continue reading
Health Canada’s Health Products and Food Branch (HPFB) Inspectorate has notified stakeholders that Canada’s Food and Drug Regulations have been amended. The change extends Division 1A – Establishment Licensing and Division 2 – Good Manufacturing Practices (GMP) to active ingredients used in pharmaceutical drugs for human use Continue reading
On October 11, 2013 the Government of Canada outlined actions it will take to communicate more effectively on recall-related risks to the public. This announcement comes after an independent report into a high profile recall earlier this year. Although Health Canada Continue reading
Health Canada’s Post-NOC Quality Document (September 2011) was issued to clarify the categorization of Level I and III submissions due to the elimination of Level II Notifiable Changes.
Recently, Health Canada released a revised version Continue reading
Health Canada has adopted the ICH Guidance Document :Periodic Benefit-Risk Evaluation Report. The Periodic Benefit-Risk Evaluation Report (PBRER) described in this guideline is intended to Continue reading
June 2013. Health Canada has updated the Table of Product Monograph Brand Safety information Continue reading