Drug Submission Requirements for Patented Drug Products and Biosimilars to the BC Ministry of Health
On this page...
- Drug review timelines
- Submitting the documents
- Drug Submission Requirements
- Requesting a priority review
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.
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 9 months and for a complex review is 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. In general, the Ministry will conduct a standard review with an internal 9 month timeline if the CDR conducts a standard review.
- For other patented drug submissions, including line extensions, coverage status, and blood glucose test strips, the review start date will be the date the complete submission is received by the Ministry. In general, the Ministry will conduct a complex review with a 12 month timeline for non-CDR drug submissions.
Refer to the Quarterly Report on Drug Submission Reviews (PDF, 507KB) for review period information on recently reviewed patented drugs.
Send the complete drug submission package to the courier address below. For all other correspondence, use the regular correspondence address.
Courier Packages to:
Director, Formulary Management
Regular Correspondence to:
Director, Formulary Management
Submissions e-mailed to the Ministry will not be accepted for review. For all drug submissions with incomplete information, the sponsor will be contacted with a request to complete the submission. Incomplete submissions will not be reviewed.
Criteria for specific submissions
|Includes Category 1 and 2 submission requirements for new drugs, drugs with new indications, new combination products, and biosimilars to CDR for review.|
Includes, and is not limited to: new strengths, delivery mechanisms, dosage forms, and biosimilars.
Priority reviews are considered only if submissions meet specific criteria. See Requesting Priority review
Additional information on the drug review process
- Sponsor Engagement in the Drug Review Process
- The Drug Review Process in B.C.—Detailed (PDF, 257KB)
- Drug Submission Guidelines for Generic Drug Products
If you have any questions about specific drug submissions, or the drug submission process, send an email to the Ministry of Health Formulary Management team at: DrugReviewProcess@gov.bc.ca