Drug Submission Requirements for Patented Drug Products and Biosimilars to the BC Ministry of Health

On this page...

Overview

Drug submission sponsors (sponsors) are required to apply to the Ministry of Health to have their drug product considered as a PharmaCare benefit. The following information outlines the submission requirements for patented drug products that must be submitted to the Ministry.

The Ministry makes PharmaCare coverage decisions based on a range of considerations including existing PharmaCare policies, programs, therapeutic options, resources and the evidence-informed recommendations of an independent advisory body, the Drug Benefit Council (DBC). The DBC’s advice to the Ministry is based upon a review of many considerations, as well as available clinical and pharmacoeconomic evidence, clinical practice, patient and ethical considerations, and the recommendations of the national Common Drug Review (CDR), when applicable.

In order for patented drug product submissions for new drugs, new combination products, and drugs with new indications to be considered by the Ministry, the submission must undergo an initial review by the CDR. Drug products that are designated as biosimilars are also required to go through the CDR process.

All other submissions, including those for line extensions and modification of criteria should be submitted directly to the Ministry.

Drug Review Timelines

The target timeline to a decision (time-to-decision) is defined as the time from when the Ministry begins its review to the time the Ministry publicly communicates its decision. The target timeline to a decision for a standard review is nine (9) months and for a complex review is twelve (12) months. Complex reviews may be due to the need to develop clinical coverage criteria, develop a Special Authority form, complete a Product Listing Agreement, or complete other implementation steps as required.

  • For submissions reviewed by the CDR, the review start date will be the issue date of the final Canadian Drug Expert Committee (CDEC) Recommendation and Reasons for Recommendation.
  • For other patented drug submissions (including line extensions and modification of criteria), the review start date will be the date the complete submission is received by the Ministry.

Refer to the Quarterly Report on Drug Submission Reviews (PDF, 507KB) for review period information on recently reviewed patented drugs.

Submitting the Documents

Send the complete drug submission package to the courier address below:

Director, Formulary Management
Medical Beneficiary and Pharmaceutical Services Division
BC Ministry of Health
1515 Blanshard Street 
Victoria BC  V8W 3C8

Please address regular correspondence to:

Director, Formulary Management
Medical Beneficiary and Pharmaceutical Services Division
BC Ministry of Health
PO BOX 9652 STN PROV GOVT
Victoria BC  V8W 9P4

Submissions e-mailed to the Ministry will not be accepted for review. For all drug submissions with incomplete information, the manufacturer will be contacted with a request to complete the submission. Incomplete submissions will not be reviewed.

Drug Submission Requirements

Criteria for specific submissions

Patented drug products and biosimilars reviewed by the Common Drug Review (CDR)

Includes Category 1 and 2 submission requirements for new drugs, drugs with new indications, new combination products, and biosimilars to CDR for review.

Modification of Current Coverage Criteria

 

Line Extensions (New Strengths)

 

Blood Glucose Test Strips (BGTS)

 

Criteria for a Priority Review

Priority reviews are considered only if submissions meet specific criteria. See Requesting Priority review

Resources

Additional information on the drug review process