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Program directory · Health Canada

Biologic and Radiopharmaceutical Drugs

Department
Health Canada
Program code
BVH02 (H)
Core responsibility
Health Protection and Promotion
In Departmental Plans
2018-19 – 2026-27 · New since an earlier plan

What it does

The Program is responsible for ensuring biologic and radiopharmaceutical drugs in Canada meet the safety, effectiveness, and quality requirements of the Food and Drug Regulations (the Regulations). It verifies that these requirements are met through pre-market submission reviews, risk-benefit assessments, monitoring, surveillance, and compliance and enforcement activities. It also provides information to Canadians and health professionals to enable them to make informed decisions about product use. Target stakeholders include industry (including market authorization holders and registered establishment license holders), health professionals and practitioners, and Canadians. Key stakeholder roles are to comply with responsibilities under the Food and Drugs Act and Regulations (industry); to promote the appropriate use of biologic and radiopharmaceutical drugs (health professionals and practitioners); and to report adverse reactions, also known as side effects, to Health Canada (industry; health care professionals/practitioners, hospitals; and Canadians).

Source: the department's Program Inventory, via GC InfoBase.

History and lineage

First appears in GC InfoBase's actual spending by program in 2018-19. The data does not record when a program was created; it may be older than its first appearance here, which is limited by the sources (program spending starts in 2010-11, Departmental Plans in 2018-19).

2018-192019-202020-212021-222022-232023-242024-252025-262026-272027-282028-29Biologic and Radiopharmaceutical Drugs 2018-19: $53MBiologic and Radiopharmaceutical Drugs 2019-20: $59.2MBiologic and Radiopharmaceutical Drugs 2020-21: $57.2MBiologic and Radiopharmaceutical Drugs 2021-22: $64.3MBiologic and Radiopharmaceutical Drugs 2022-23: $59.6MBiologic and Radiopharmaceutical Drugs 2023-24: $63MBiologic and Radiopharmaceutical Drugs 2024-25: $59.4MBiologic and Radiopharmaceutical Drugs 2025-26: $52.3MBiologic and Radiopharmaceutical Drugs 2026-27: $51.7MBiologic and Radiopharmaceutical Drugs 2027-28: $46.9MBiologic and Radiopharmaceutical Drugs 2028-29: $42.4MBiologic and Radiopharmaceutical DrugsBiologics & Radiopharmaceutical DrugsBiologic and Radiopharmaceutical Drugs
Bars: spending by fiscal year (dark: actual; light: actual restated on the 2017-18 program structure; outlined: the latest plan's forecast; grey: related programs). Bands: each program in the lineage over the years it has data. The line at the bottom shows this program's names over time.
ProgramRelationYears with dataActual spending over those years
Biologic and Radiopharmaceutical DrugsThis program2018-19 – 2028-29$416M

No earlier or later program in the same department has a similar name.

Significant changes in scope and budget

Detected from the data: renames between plans, programs it appears to replace, merge with or split into (matched by name), year-over-year changes in spending of at least 25% and $5M, or in employees of at least 20% and 25 FTEs, linked budget measures, and results indicators added or dropped.

YearWhat changedSource
2022-23Renamed from “Biologics & Radiopharmaceutical Drugs” to “Biologic and Radiopharmaceutical Drugs”.GC InfoBase program names by year
2025-26Planned employees (FTEs) 429, against 594 in 2024-25 (−28%).FTEs (GC InfoBase)

Success criteria

The program's indicators from its department's Departmental Results Framework: the target set in each year's plan, and the result reported the following year. Source: GC InfoBase.

Historical: targets against results

Percentage of biologic and radiopharmaceutical drug submissions that meet regulatory requirements
Expected result: Regulated parties are compliant with regulatory requirements
96%2018-19✗ not met93%2019-20✓ met98%2020-21✓ met98%2021-22✓ met95%2022-23✓ met94.2%2023-24✓ met97%2024-25✓ met

Bars: result reported. Dashed line: target.

Report yearTargetDueResultStatus
2018-1985% – 95%201996%
The results surpassed the planned target and indicates a positive direction.
Not met
2019-20≥ 90%202093%Met
2020-21≥ 90%202198%Met
2021-22≥ 90%202298%Met
2022-23≥ 90%202395%Met
2023-24≥ 93%202494.2%Met
2024-25≥ 93%202597%Met
Percentage of risk communications targeted to health professionals disseminated within service standards
Expected result: Partners, stakeholders and Canadians are informed of the risks and benefits of biologic and radiopharmaceutical drugs
100%2018-19✓ met75%2019-20✗ not met100%2020-21✓ met100%2021-22✓ met100%2022-23✓ met100%2023-24✓ met100%2024-25✓ met

Bars: result reported. Dashed line: target.

Report yearTargetDueResultStatus
2018-1990% – 100%2019100%Met
2019-20≥ 90%202075%
Three out of four risk communications were disseminated within service standards. Given that the total number of risk communications is small, missing a service standard will have a disproportionate effect on overall performance.
Not met
2020-21≥ 90%2021100%Met
2021-22≥ 90%2022100%Met
2022-23≥ 90%2023100%Met
2023-24≥ 90%2024100%Met
2024-25≥ 90%2025100%Met

Current: the 2026-27 plan's targets

Percentage of biologic and radiopharmaceutical drug submissions that meet regulatory requirements
Expected result: Regulated parties are compliant with regulatory requirements
93%2026-27

Bars: result reported. Dashed line: target.

Report yearTargetDueResultStatus
2026-27≥ 93%2027—Planned
Percentage of risk communications targeted to health professionals disseminated within service standards
Expected result: Partners, stakeholders and Canadians are informed of the risks and benefits of biologic and radiopharmaceutical drugs
90%2026-27

Bars: result reported. Dashed line: target.

Report yearTargetDueResultStatus
2026-27≥ 90%2027—Planned

Future goals: targets due after 2026-27

No targets with a later due date.

Spending and employees: planned against actual

Spending

2018-19: $51M2018-19: $53M2018-192019-20: $46.8M2019-20: $59.2M2019-202020-21: $48.7M2020-21: $57.2M2020-212021-22: $57.6M2021-22: $64.3M2021-222022-23: $49.8M2022-23: $59.6M2022-232023-24: $48.3M2023-24: $63M2023-242024-25: $52.2M2024-25: $59.4M2024-252025-26: $52.3M2025-262026-27: $51.7M2026-272027-28: $46.9M2027-282028-29: $42.4M2028-29
Outlined bar: planned in that year's Departmental Plan (dashed: the latest plan, for years not yet reported). Filled bar: actual.
Show the numbers
Fiscal yearPlannedActual
2018-19$51M$53M
2019-20$46.8M$59.2M
2020-21$48.7M$57.2M
2021-22$57.6M$64.3M
2022-23$49.8M$59.6M
2023-24$48.3M$63M
2024-25$52.2M$59.4M
2025-26$52.3M—
2026-27$51.7M—
2027-28$46.9M*—
2028-29$42.4M*—

Employees (FTEs)

2018-19: 5012018-19: 5222018-192019-20: 4832019-20: 5652019-202020-21: 4972020-21: 5662020-212021-22: 5162021-22: 6282021-222022-23: 4172022-23: 5912022-232023-24: 4302023-24: 5802023-242024-25: 4322024-25: 5942024-252025-26: 4292025-262026-27: 4242026-272027-28: 4282027-282028-29: 3632028-29
Outlined bar: planned in that year's Departmental Plan (dashed: the latest plan, for years not yet reported). Filled bar: actual.
Show the numbers
Fiscal yearPlannedActual
2018-19501522
2019-20483565
2020-21497566
2021-22516628
2022-23417591
2023-24430580
2024-25432594
2025-26429—
2026-27424—
2027-28428*—
2028-29363*—

Planned spending, plan by plan

Each row is one year's Departmental Plan and its forecast for the next three fiscal years; read a column down to see how the forecast for one year changed. The last row is what was actually spent. Click an amount for its source. Biggest changes in federal spending plans

Actual spending is from Departmental Results Reports and the Public Accounts, as published in GC InfoBase. FTEs are full-time equivalents.