Last week, CADTH shared its new Procedure and Submission Guidelines for the CADTH Common Drug Review document which combines the previously separate procedure and submission guidelines into a single document. Manufacturers are encouraged to follow the new guidelines immediately, however new submission requirements will be only be enforced for ... Read More
News & Events
03
Jul2018
28
Jun2018
Health Canada, CADTH & INESS Collaborate on Aligned Drug Review Processes
/ CADTH, Health Canada, INESSS
Health Canada, CADTH, and Quebec’s Institut national d’excellence en santé et en services sociaux (INESSS) have officially launched efforts to align regulatory and health technology assessment (HTA) drug reviews for eligible submissions, effective immediately.
Background
The new process stems from Health Canada and HTAs recognizing the need for greater coordination of the ... Read More
14
Jun2018
On June 13, 2018, after considerable time in development, the pCPA released its Brand Process Guidelines for external feedback. The pCPA is interested in receiving feedback from all sectors with a stake in the negotiation process: brand and generic pharmaceutical companies, patient organizations, and other interested parties.
The guidance documents, which ... Read More
31
May2018
2019 CDEC Meeting Schedule Released
A new schedule format includes submission deadlines and guidance on when manufacturers can expect embargoed and final recommendations.
Updated Advance Notification Form (effective immediately)
New form includes an acknowledgement that information provided in the form may be shared with federal, provincial and territorial ... Read More
22
May2018
PDCI Market Access is delighted to participate in the 4th Annual Canadian Institute’s Pharma Symposium. The Pharma Symposium brings together leading stakeholders from pharmaceutical manufacturers, public/private payers, agencies, regulatory bodies and patient groups to analyze the key issues facing the industry in today’s complex environment. Participants will gain insights as ... Read More
11
May2018
PMPRB has released its May 2018 NEWSletter which includes anticipated updates on PMPRB’s timelines for its Guidelines modernization initiative:
June 2018:
PMPRB to release more specific guidance on how the PMPRB foresees operationalizing regulatory changes
PMPRB to form a multi-stakeholder Working Group to gather input on key technical aspects of ... Read More
04
May2018
The pan-Canadian Pharmaceutical Alliance (pCPA) updated the status of negotiations on brand name drugs as of April 30th, 2018:
46 negotiations are currently underway with 7 new files added since the last update of March 31st, 2018:
Adlyxine (lixisenatide): Used to treat type 2 diabetes mellitus
Ilaris (canakinumab): Used ... Read More
30
Apr2018
On April 27, 2018, Québec’s Institut national d’excellence en santé et en services sociaux (INESSS) released a notice to manufacturers advising that their submission guide document, submission checklists and various forms and letter templates have been updated effective immediately.
For more information, please consult the following link or the ... Read More
19
Apr2018
Standing Committee on Health Publishes Report & Recommendations on National Pharmacare
/ Canada, What's New
Following Question Period this afternoon, the House of Commons Standing Committee on Health released its long-anticipated report on the development of a national pharmacare program in Canada.
The report, entitled Pharmacare Now: Prescription Medicine Coverage for All Canadians, is the culmination of two years of evidence considered by the Committee ... Read More
12
Apr2018
A new Patient Evidence Submission Tip Sheet offers guidance to patient groups on the types of information that should be included in a CADTH pan-Canadian Oncology Drug Review (pCODR) patient group input submission, as well as how the evidence can best be presented.
The new Tip Sheet, along with the ... Read More