Drug reviews
Last updated on June 18, 2026
This page has information for health industry professionals about how BC PharmaCare reviews drugs for coverage.
On this page
- Overview
- Drug review process
- Drug manufacturer input
- Clinician input
- How to make submissions
- BC PharmaCare and health authorities joint drug reviews
- About the Drug Benefit Council (DBC)
- Join our clinician roster
Overview
PharmaCare reviews patented drugs, generic drugs, biologics and biosimilars that have been submitted for coverage consideration by drug manufacturers.
The review ensures that PharmaCare coverage is fair, effective and sustainable. Only drugs submitted by the manufacturer are considered for coverage.
Drug review process
In Canada, the drug review process has three stages.
Stage 1
All patented and generic drugs sold in Canada require a Notice of Compliance (NOC). The NOC is issued by Health Canada after a review of the drug’s safety, effectiveness and manufacturing quality. Health Canada’s review can take between one and two years.
Stage 2
Stage 2 is a review by Canada's Drug Agency (CDA). Drug manufacturers must submit applications for:
- New chemical and biologic entities
- New combination drugs
- New indications
- Biosimilars
Generic drugs are not reviewed by Canada's Drug Agency since they are copies of patented drugs, which have already been reviewed.
CDA reviews patient input and prepares clinical and pharmacoeconomic evidence reports. The reviews, related input and reports are sent to the Canadian Drug Expert Committee (CDEC), an advisory body to CDA.
CDEC makes a recommendation to CDA based on how well the drug works compared to similar drugs used to treat the same condition, and whether the drug provides value for money. CDEC advises provincial plans to do one of the following:
- Provide coverage
- Provide coverage with clinical criteria
- Not provide coverage
The pan-Canadian Pharmaceutical Alliance process
Once CDA releases its final recommendation based on the advice of CDEC, the pan-Canadian Pharmaceutical Alliance (pCPA) begins negotiations with the drug manufacturer. Provinces and territories participating in negotiations collaborate to achieve better value for brand-name and generic products.
Stage 3
PharmaCare conducts its own drug review before making a final coverage decision. Drugs are submitted to CDA and PharmaCare at the same time. Only drugs submitted to PharmaCare can be covered by PharmaCare.
Drug manufacturer input
Drug manufacturers submitting drugs may provide input at three points along the review process.
1. After the CDA review
CDEC, the advisory body that reviews findings and makes a recommendation to CDA, shares an embargoed drug coverage recommendation and reasons for the recommendation with provincial drug plans and the drug manufacturer.
The drug manufacturer can then provide PharmaCare with objective feedback on the CDEC recommendation. Feedback must be evidence-based and referenced, indicate whether the manufacturer agrees or disagrees with the CDEC recommendation and cannot introduce new clinical evidence. This feedback is considered during the PharmaCare review.
2. Before PharmaCare makes a coverage decision
Drug manufacturers can request a meeting with PharmaCare to discuss the DBC recommendation and related issues during this time by submitting a written statement to pharma@gov.bc.ca
PharmaCare can also initiate discussions with the drug manufacturer during this period.
3. After PharmaCare makes a coverage decision
Drug manufacturers can file a resubmission if new information becomes available that addresses the reasons for PharmaCare’s coverage decision.
Drug manufacturers also review reports created during the review process before PharmaCare makes them public. Drug manufacturers have 15 days to request the non-disclosure of specific information they consider confidential or proprietary. The information will be redacted before the documents are made public. The 15-day period can be adjusted upon mutual agreement between PharmaCare and the drug manufacturer.
Clinician input
Clinicians can contribute their expertise to the drug review process in the form of clinical practice input.
This involves the Ministry of Health seeking and obtaining input from experts to assist with the each drug review.
How reviewers are selected
The Ministry will reach out to expert clinicians for input on the drug submission being reviewed. The Ministry considers:
- The requirements of the drug submission
- The expertise of the potential reviewer
If you are interested in providing clinical practice input, submit your name, contact information, areas of specialization and expertise to DrugReviewProcess@gov.bc.ca
How to make submissions
Patented drug products and biosimilars
Before submitting, review the appropriate checklist to make sure you are including everything required. Incomplete submissions will not be reviewed.
Secure file transfer
- Dropbox, Onedrive, and Sharepoint are secure online file storage services. Organize file transfer by emailing DrugReviewProcess@gov.bc.ca
- Compress: Remove non-essential graphics and compress the submission, preferably using Microsoft Windows
- Rename: Rename the compressed file to remove the .zip extension. Government email programs reject emails with a .zip attachment
- Encrypt: Encrypt the submission package using AES-128 encryption standards or better, preferably using Microsoft Windows
- Submit: Send the compressed, encrypted file to DrugReviewProcess@gov.bc.ca. Send the decryption password to the same address in a separate email. Drug Review staff will confirm they have received the submission
Submission checklists
- Submissions for patented drug products and biosimilars
- Submitting price changes
- Foreign-authorized drug submissions
Submissions must meet the criteria on these checklists:
- Patented drugs submission checklist (PDF, 131KB)
- Biosimilars submission checklist (PDF, 188KB) and biosimilars submission template (PDF, 1.576MB)
- Modification of current coverage criteria submission checklist (PDF, 117KB)
- Line extensions submission checklist (PDF, 117KB)
- Blood glucose test strips submission checklist (PDF, 105KB)
Generic drug products
BC PharmaCare and health authorities joint drug reviews
PharmaCare and B.C.’s health authorities began a joint drug review pilot on July 31, 2023. Aligned formularies support patient access to safe, effective, and affordable pharmaceutical therapies across the province. The joint review process includes only medications that health authorities are interested in.
The Ministry of Health and health authorities continue to work together on joint reviews. The process is regularly evaluated, adjusted, and improved to ensure its success.
About the Drug Benefit Council (DBC)
The Drug Benefit Council (DBC) is an independent advisory body that makes evidence-informed recommendations to the Ministry of Health about Ministry initiated drug listings in the PharmaCare formulary.
The DBC is made up of 12 members: 9 professional members with expertise in critical appraisal, medicine, ethics, pharmacy and health economics; and 3 public members. The full list of members is available at the Directory of Agencies. The Drug Review Resource Committee (DRRC), a subcommittee of the DBC, is made up of 4 members from the DBC. For their remuneration details, view Drug Benefit Council Fees (PDF, 75KB).
DBC members are held to the highest ethical standards when conducting reviews and making recommendations. Their activities are governed by the DBC’s Terms of Reference (PDF, 51KB). All individuals involved in the drug benefit review process, including DBC members, are subject to the process's Conflict of Interest Guidelines (PDF, 179KB).
Join our clinician roster
Are you a general practitioner or specialist interested in participating in B.C.'s drug review process as a clinical practice reviewer? Send your contact information, area(s) of specialization or expertise, and/or medical practice interests to DrugReviewProcess@gov.bc.ca
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