On October 12, 2017, Québec’s Institut national d’excellence en santé et en services sociaux (INESSS) released a notice to manufacturers announcing the details on the process for the mandatory notification required for submissions. As of November 1, 2017, manufacturers are required to inform INESSS at least 2 months in advance ... Read More
17
Oct2017
12
Oct2017
On October 11, 2017, the Canadian Agency for Drugs and Technologies in Health (CADTH) released a new CDR Update (Issue 129). Based on feedback from stakeholders, CADTH will be implementing the proposed revision to the resubmission eligibility criteria and a new randomized controlled trial will no longer be required ... Read More
11
Oct2017
The pan-Canadian Pharmaceutical Alliance (pCPA) updated the status of negotiations on brand name drugs as of September 30, 2017:
51 negotiations are currently underway with 6 new files added since the last update of August 31, 2017:
Fibristal (ulipristal acetate): Used to treat uterine fibroids (2nd cycle pre-surgery)
Glatect ... Read More
29
Sep2017
On September 29, 2017, Québec’s Institut national d’excellence en santé et en services sociaux (INESSS) released a notice to manufacturers announcing the details on the process for the admissibility of submission applications for registration. A manufacturer can submit an application for registration to INESSS only when all required documents are ... Read More
29
Sep2017
On September 28, 2017, the Canadian Agency for Drugs and Technologies in Health (CADTH) released a new CDR Update (Issue 128) describing the following changes.
Revised Procedure for Advance Notification of Pending CDR Submissions and Resubmissions
CADTH has received numerous inquiries regarding challenges interpreting and complying with the ... Read More
12
Sep2017
On September 11, 2017, the Canadian Agency for Drugs and Technologies in Health (CADTH) released a new CDR Update (Issue 127) describing the following changes.
Extended Initiation Range for January 2018 CDEC Meeting
CADTH has extended the initiation range for its Common Drug Review (CDR) submissions targeting the January 17, ... Read More
11
Sep2017
The pan-Canadian Pharmaceutical Alliance (pCPA) updated the status of negotiations on brand name drugs as of August 31, 2017:
47 negotiations are currently underway with 6 new files added since the last update of July 31, 2017:
Brilinta (ticagrelor): Used with ASA to prevent atherothrombotic events with history ... Read More
08
Sep2017
On September 7, 2017, the Institut national d’excellence en santé et en services sociaux (INESSS) released the list of medications for which a registration application was submitted for the February 2018 list update as well as the medications pending a Health Canada Notice of Compliance to be reviewed.
Health professionals, citizens, ... Read More
23
Aug2017
PDCI has now published its information sharing webpage which aggregates submissions made by individuals and organizations in response to Health Canada’s Consultation on Proposed Amendments to the Patented Medicines Regulations.
Click Here to Visit PDCI’s Information Sharing Webpage.
The submissions have been provided by individuals & organizations on a completely voluntary ... Read More
22
Aug2017
***Participation Requested***
Sharing Responses to Health Canada’s Consultation on Proposed
Amendments to the Patented Medicines Regulations
In May 2017, Federal Minister of Health Jane Philpott, launched a consultation on proposed amendments to the Patented Medicines Regulations that would have significant effects on how patented ... Read More