Evaluation of the Biologic and Radiopharmaceutical Drugs Program 2019-2020 to 2023-2024
Final report: Executive summary and Management Response and Action Plan
March 2025
Prepared by the Office of Audit and Evaluation
Health Canada
Note: The complete evaluation report is available on request. Please send an email to oae-bae@phac-aspc.gc.ca.
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Executive summary
Background and evaluation scope
The evaluation assessed the impact of the Biologic and Radiopharmaceutical Drugs Program's (the Program) activities and its agility in addressing current and emerging needs over the 2019-2020 to 2023-2024 period. The Program regulates biologic and radiopharmaceutical drugs, as well as human blood and blood components, cells, tissues, and organs (CTOs) for human use in Canada. The Program is also the regulatory authority responsible for the Assisted Human Reproduction Act and its supporting regulation.
Drug shortage-related activities were not in the scope of this evaluation, as they were included in recent internal audit and evaluation reports released in 2024. Activities related to pharmaceutical drugs, natural health products, and medical devices were also excluded from this evaluation, as there are separate evaluations to assess these activities.
Findings
Over the past five years, within its regulatory mandate, Health Canada has ensured that authorized products meet the regulatory requirements for safety, efficacy and quality for biologic and radiopharmaceutical drugs.
Regulatory changes initiated many years ago and piloted under an Interim Order during the COVID-19 pandemic allowed the Program to review, authorize (where appropriate) and monitor COVID-19 vaccines and treatments in a timely manner, while maintaining safety standards and regulatory requirements and providing ongoing public information on these drugs to Canadians.
Health Canada's strong performance was due in large part to temporary funding associated with the COVID-19 pandemic. As temporary funding has now ended, the Program is still managing a high volume of complex submissions as well as increased expectations, and is issuing authorization decisions later than established by service standards, resulting in remissions of cost-recovery fees.
Despite implementing a number of optimization measures, the volume and variety of priorities that go beyond the core mandate exceed the Program's current capacity and these should be scaled down to align with resources. There is also a need to harmonize processes, where applicable, for all pharmaceutical, biologic, and radiopharmaceutical drugs that fall under the same Act and Regulations to enhance regulator consistency for the industry and the post-market activities. Finally, optimizing the use of information garnered from international partners could support program areas impacted by heavy workload and lead to greater system efficiency for potentially lower-risk authorizations.
Recommendations
An evaluation of the Pharmaceutical Drugs Program was completed in January 2024. Since the Pharmaceutical Drugs Program (PDP) and the Biologic and Radiopharmaceutical Drugs Program both work with overlapping industries, recommendations that affect both programs will not be duplicated. These were:
- review and update PDP's communications approach to ensure stakeholders can access relevant information; and
- enhance information technology systems to support PDP activities, including integration across the regulatory life cycle.
Recommendation 1
Align Program priorities with available resources.
The Program workload has increased over the last five years to a point where authorization decisions are starting to be issued later than service standard targets, resulting in remissions of cost-recovery fees. Various factors contribute to the Program heavy workload, including:
- the increased volume and complexity of submissions;
- rising expectations in terms of rapid authorization and safety monitoring;
- multiple simultaneous priorities within the Health Products and Food Branch (HPFB); and
- more demanding safety monitoring for authorized drugs for which initial evidence is limited (such as for rare disease drugs).
There is a need to reduce Program priorities to refocus on Health Canada's legislated mandate and core objectives.
Recommendation 2
Align processes and requirements for drugs falling under the Food and Drugs Act and Food and Drug Regulations between the Biologic and Radiopharmaceutical Drugs Program and the Pharmaceutical Drugs Program, where feasible and appropriate.
The Biologic and Radiopharmaceutical Drugs Program and the Pharmaceutical Drugs Program both work with overlapping industries under the same Act and Regulations. However, certain pre-market processes, requirements and tools can create inconsistencies, which lead to confusion for sponsors when they interact with the Pharmaceutical Drugs Directorate (PDD) and the Biologic and Radiopharmaceutical Drugs Directorate (BRDD) regarding different types of drugs. They also create inconsistencies and duplicate work for the Marketing Health Products Directorate (MHPD), which has to adapt its post-market processes according to which directorate has approved a drug product. There is a need to align processes for all drugs to enhance regulator consistency for products under the same Act and Regulations, and facilitate the work across HPFB.
Recommendation 3
Increase the use of trusted international partners' information and analysis to support pre-market decisions and access to drugs.
While the Program is successful in leveraging inspection results from trusted international regulatory partners, its reliance on those partners' pre-market analyses to inform decisions on authorizations is limited.
A risk-based approach that would leverage other trusted regulators' analysis and authorization decisions, as applicable, might be an improvement, as the international context permits. Lessons could also be learned from international partners on how to enhance access to pediatric drugs.
Management Response and Action Plan
Recommendation 1
Align Program priorities with available resources.
Management response
Management agrees that there is a need to streamline Program priorities to refocus on the legislated mandate so that priorities do not exceed Program capacities.
Recent changes to government spending and capacity have resulted in the Health Products and Food Branch (HPFB) and the Regulatory Operations and Enforcement Branch (ROEB) undertaking respective planning activities with the goal of identifying and focusing resources on core activities. These planning activities prioritize fulfilling regulatory and other legal obligations. Sharing of respective branch program priorities will further support meeting this objective.
| Action plan | Deliverables | Expected completion date | Accountability | Resources |
|---|---|---|---|---|
| 1.1 Building on respective Branch planning processes, HPFB and ROEB will engage and share plans and priorities. | 1.1.1 ROEB to meet with HPFB to share ROEB Branch planning process. | September 2025 | ADM for ROEB; Planning and Operations Directorate (POD) with Health Product Compliance Directorate (HPCD) and Medical Devices and Clinical Compliance Directorate (MDCCD) | Within existing resources, led by POD with HPCD and MDCCD |
| 1.1.2 HPFB to meet with ROEB to share HPFB Branch Planning process. | January 2026 | ADM for HPFB; Business Facilitation Modernization Directorate (BFMD) with Biologic and Radiopharmaceutical Drugs Directorate (BRDD), Marketed Health Products Directorate (MHPD), Pharmaceutical Drugs Directorate (PDD) and Planning, Policy and International Affairs Directorate (PPIAD) | Within existing resources, led by BFMD with BRDD, MHPD, PDD and PPIAD | |
| 1.1.3 Priorities are shared amongst program partners. | January 2027 | ADM for HPFB; BFMD with BRDD, MHPD, PDD and PPIAD and ROEB; HPCD and MDCCD with POD | Within existing resources, led by BFMD with BRDD, MHPD, PDD and PPIAD and ROEB (HPCD and MDCCD with POD) |
Recommendation 2
Align processes and requirements falling under the Food and Drugs Act and the Food and Drug Regulations between the Biologic and Radiopharmaceutical Drugs Program and the Pharmaceutical Drugs Program, where feasible and appropriate.
Management response
Management has agreed to take steps to assess how the Biologic and Radiopharmaceutical Drugs Program and the Pharmaceutical Drugs Program's core regulatory work is carried out under the Food and Drugs Act and the Food and Drug Regulations. By reviewing current processes, with a particular focus on any areas where programs and directorates may have divergent procedures, we aim to identify potential inconsistencies and opportunities for greater efficiency.
| Action plan | Deliverables | Expected completion date | Accountability | Resources |
|---|---|---|---|---|
| 2.1 Identify areas of concern in a process divergence register. | 2.1.1 Directorates to identify areas of divergence in processes, focusing on interactions between program directorates within HPFB and industry. | April 2026 | ADM for HPFB; BRDD, PDD and MHPD | Within existing resources, led by BRDD, with PDD and MHPD |
| 2.1.2 Summarized information will be presented to the HPFB Directorate Management Teams for consideration. | October 2026 | ADM for HPFB; BRDD, PDD and MHPD | Within existing resources, led by BRDD with PDD and MHPD |
Recommendation 3
Increase the use of trusted international partners' information and analysis to support pre-market decisions and access to drugs.
Management response
Management agrees and supports international collaborations and will continue to consider how international partners' work can be best leveraged to inform pre-market drug decisions. In fact, this work to leverage the use of foreign regulatory information has been underway for over a decade, with consultations, guidance, and legislative and regulatory development (for example, precision regulating, Project Orbis). Of note, in February 2025, the Pharmaceutical Drugs Program developed a Standard Operating Procedure (SOP) on the Use of Foreign Reviews.
| Action plan | Deliverables | Expected completion date | Accountability | Resources |
|---|---|---|---|---|
| 3.1 The Program will revisit its use of international partners' information and refresh documentation and processes, as necessary. | 3.1.1 HPFB to review and consider approval of the SOP on the Use of Foreign Review Process for the BRP. | January 2026 | ADM for HPFB; BRDD, PDD | Within existing resources, led by BRDD with PDD |
| 3.1.2 If the SOP is approved for the BRP, HPFB will initiate SOP training. | January 2027 | ADM for HPFB; BRDD, PDD | Within existing resources, led by BRDD with PDD |
Note: The work to address the Management Response and Action Plan will be undertaken in an environment where there are limited resources and competing priorities. As such, deliverables may need to be reconsidered moving forward.
Recommendations #2 (communications) and #3 (information technology systems) made for the Evaluation of the Pharmaceutical Drugs Program, completed in January 2024, also apply to the evaluation of Biologic and Radiopharmaceutical Drugs Program.
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