Private: Gallery Post #1

31

Jul2014

CADTH: Feedback Requested on Industry Application Fee Guidelines

The Canadian Agency for Drugs and Technologies in Health (CADTH) is requesting stakeholder feedback on its draft guidance document, released today, concerning its recent announcement to introduce industry application fees for manufacturer submissions and resubmissions made to the Common Drug Review. The draft Guidelines for Manufacturers on Application Fees ... Read More

30

Jul2014

CADTH: CDR Update – Issue 106

An updated table with the targeted Canadian Drug Expert Committee (CDEC) meeting dates is now available on the CADTH website A CDEC meeting will be held in December 2014 as part of an initiative to eliminate an accumulation of CDR submissions. CADTH is extending the pilot process for receiving patient input ... Read More

29

Jul2014

New Brunswick: Rare diseases drug plan established

New Brunswick is the latest Canadian province to establish a specialized drug plan to fund high cost drugs for certain rare diseases. Starting August 1,2014, the planwill begin accepting applications to cover the cost of five drugs for the following specific rare diseases: Aldurazyme for the treatment of Hurler and Hurler-Scheie ... Read More

24

Jul2014

pCODR: Summary Report from Stakeholder Consultations on Transfer of pCODR to CADTH

Following the transfer of the pan-Canadian Oncology Drug Review (pCODR) to CADTH beginning in April 2014, a survey was conducted to identify stakeholder concerns regarding the transfer. Stakeholder Information Sessions on the transfer held on June 9, 2014 were attended by patient advocacy groups, oncology professionals, pharmaceutical manufacturers, associations, and consultants. ... Read More

09

Jul2014

PMPRB 2013 Annual Report Delayed

The Federal Government had not tabled the PMPRB 2013 Annual Report when Parliament rose on June 20th, 2014 although the report would have been submitted by the PMPRB to the Minister of Health in May 2014. There are two summer adjournment tabling dates (July 16th and August 20th) when the ... Read More

08

Jul2014

CADTH: CDR Update – Issue 105 – Patient Input

Effective July 2, 2014, patient groups will now have 35 business days to prepare and submit their patient input submissions to CDR This is possible due to the mandatory pre-submission advance notice policy which will be going into effect the same day. As per the policy, manufacturers must provide a minimum ... Read More

08

Jul2014

QUEBEC: INESSS to have meetings with manufacturers for February 2015 Liste des médicaments update

The Institut national d’excellence en santé et en services sociaux will have meetings with manufacturers who have submitted applications in advance of the deadline for the February 2015 Liste des médicaments update. Discussions will address clinical studies and economic and pharmacoeconomic aspects ... Read More

27

Jun2014

PMPRB Federal Court Decision Appealed

The Attorney General of Canada is appealing the May 27 decisions of Justice O’Reilly which concluded that generics firms marketing generic products (even under a licencing agreement from the patent holder) are not patentees for purposes of PMPRB price regulation so long as there is no monopoly (market exclusivity). See ... Read More

16

Jun2014

QUEBEC: Submission deadlines published

The Ministry of Health and Social Services has authorized the Institut National d’excellence en santé et en services sociaux (INESSS) (National Institute for Excellence in Health and Social Services) to issue 7 updates in 2015 to the Liste de médicaments.  Updates will occur in February, March, April, June, July, October ... Read More

29

May2014

PMPRB jurisdiction does not extend to Generics (Federal Court Decisions)

The Federal Court (Justice O’Reilly) issued decisions May 27 in two similar cases (Sandoz 2014 FC 501 and Ratiopharm 2014 FC 502) and concluded that generics firms that market generic products (even under a licencing agreement from the patent holder) are not patentees for purposes of PMPRB price regulation so ... Read More