09

Jun2017
On June 2, 2017, Québec’s Institut national d’excellence en santé et en services sociaux (INESSS) released new submission guidelines, including a pre-NOC review procedure, to be implemented immediately. Topics to be covered include: New Pre-NOC Review Procedure & Submission Criteria New Submission Guidelines New Submission Requirements Potential Changes to List ... Read More

06

Jun2017
On June 2, 2017, Québec’s Institut national d’excellence en santé et en services sociaux (INESSS) released new submission guidelines, including a pre-NOC review procedure, to be implemented immediately. Pre-NOC Review Moving forward, INESSS will evaluate certain drug products (see the criteria here on the INESSS website) before a Notice of Compliance ... Read More

19

Apr2017
The drug products being evaluated as part of the October 2017 update to the List of Medications now been made public by INESSS. Health professionals, citizens, patients, and their associations and groups may submit comments on any of the products under consideration before May 12, 2017. As part of this ... Read More

15

Mar2017
INESSS Upcoming Meetings with Manufacturers – October 2017 “Liste des médicaments” INESSS is offering an opportunity for in-person meetings to manufacturers who have filed a submission by the March 24, 2017 deadline for drugs to be listed on the October 2017 “Liste des médicaments". These meetings will be held between April ... Read More

06

Dec2016
On December 2, 2016, Health Canada released its updated guidelines for biosimilar biologic drug submissions.  The document will provide guidance to sponsors to enable them to satisfy the information and regulatory requirements for the authorization of biosimilars in Canada. The following criteria determine the scope if products that are eligible to ... Read More

01

Dec2016
Effective December 1, 2016, all new Special Authorization requests for the treatment of Moderately to Severely Active Crohn's Disease and Fistulizing Crohn's Disease or Ulcerative Colitis for infliximab naive patients will be assessed for coverage with Inflectra. Remicade will not be approved for new infliximab starts for patients with the ... Read More

28

Nov2016
Effective November 30, 2016, the Ontario Public Drug Programs will begin funding INFLECTRA™ (infliximab) as a limited use benefit for the following new indications: LU Code 477 - For the treatment of ulcerative colitis in patients who meet clinical criteria. LU Code 478 - For the treatment of moderate to severe Crohn’s ... Read More

20

Oct2016
INESSS Upcoming Meetings with Manufacturers – June 2017 “Liste des médicaments” INESSS is offering an opportunity for in-person meetings to manufacturers who have filed a submission by the November 25, 2016 deadline for drugs to be listed on the June 2017 “Liste des médicaments". These meetings will be held between December ... Read More

11

Oct2016
Effective November 1, 2016, the ministry is introducing the application of generic substitution to the Exceptional Access Program (EAP). Under this new policy, if an EAP drug has an interchangeable generic product designated through the Off-Formulary Interchangeable (OFI) mechanism, the ministry will only approve the funding of the generic product. Where ... Read More

04

Oct2016
The Ontario Public Drug Programs (OPDP) is publishing an addendum (Addendum #1) to the Ontario Guidelines for Drug Submission and Evaluation (Guidelines) to assist the manufacturers in making drug submissions to the OPDP. Addendum #1 contains information about the regulatory amendments that were recently approved by the Ontario government and ... Read More