Private: Gallery Post #1

27

Aug2018
PMPRB published its 2017 annual report this week, recalling an eventful year (complete with proposed amendments to its overarching regulations, poised to fundamentally change its future mandate & operations) and looking forward in 2018 to working constructively with stakeholders to finalize its Guidelines modernization initiative, underway since 2016. PMPRB 2017 Annual ... Read More

03

Jul2018
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

28

Jun2018
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

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
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