In an announcement made April 24, 2017 Health Canada reaffirmed its intent to transition all regulatory submissions over to eCTD format.
Starting January 1, 2018 all New Drug Submissions (NDSs), Supplemental NDSs (SNDSs), Abbreviated Continue reading
On December 6, 2013 it was announced that a new patient safety legislation would be introduced known as the “Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law)”. The law Continue reading
Happy Holidays to our clients, friends, and family – wishing you a safe and enjoyable winter season.
As we welcome in the holidays we say goodbye to a phenomenal year that saw Regxia go through several pivotal changes that have allowed us to grow and strengthen our commitment to serve our clients.
This past year, we Continue reading
As part of Health Canada’s “ongoing efficiency measures and efforts to reduce regulatory burden on industry and transition to an electronic environment, … [Health Canada announced Continue reading
On October 23, 2014, Health Canada released a new Drug Establishment Licence (DEL) Application Form (FRM-033) with instructions. This form supersedes the Continue reading
A Certificate of a Pharmaceutical Product (CPP) is a certificate used by the Health Products and Food Branch Inspectorate (HPFB Inspectorate) “establishing the status of Continue reading
This revised Draft Guidance on Reconsideration of Decisions Issued for Human Drug Submissions is intended to describe the appropriate process to address submission-related disputes and Continue reading
August 7, 2014. Regxia’s clients speak: “Regxia has our heartfelt appreciation and sincere thanks for their effort and achievement in filing our Continue reading
Health Canada has released a consultation document regarding drug submissions relying on third-party data (literature and market experience). The guidance applies to Continue reading
Regxia Inc. is pleased to advertise that they will be exhibiting with the Drug Information Association (DIA) at their 50th Annual Meeting in San Diego from June 15-19. Regxia will be occupying Booth 1944 and Continue reading