06

Jun2017

NEW: INESSS Releases New Submission Guidelines – Implementation of Pre-NOC Review Procedure

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

New INESSS Questionnaires Released for Medicines Under Review

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 Manufacturer Appointments

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

Health Canada Releases Guidance Document for Biosimilar Biologic Drug Submissions

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

Alberta Changes Special Authorization Criteria for Coverage of INFLECTRA™ (infliximab)

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

Ontario Public Drug Programs Funds New Indications for INFLECTRA™ (infliximab)

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 Manufacturer Appointments

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

Application of Generic Substitution to the Exceptional Access Program (EAP)

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

Addendum #1 to Ontario Guidelines for Drug Submission and Evaluation to the Ontario Public Drug Programs

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

28

Sep2016

Alberta Releases New Amendments to Price Policy

Alberta Health amended their price policy on September 26, 2016 to come into effect on October 1, 2016. The following amendments were made: Amendment to the Maximum Allowable (MAC) Price Policy of the Alberta Price Policy Effective October 1, 2016, the MAC Price Policy, section 2-14, will be amended to include eligible ... Read More