Regulatory Operations and Regions Branch: Adapting to the Changing Regulatory Landscape

2018 Certificate Program in Regulatory Leadership – Study Tour

Steven Schwendt February 6, 2018

1. Describe the changing regulatory context;

2. Introduce Health Canada’s new Regulatory Operations and

Regions Branch (RORB); and,

3. Describe how RORB is adapting to the changing environment.

Purpose

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Changing Regulatory Context

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• All facets of the regulatory enterprise of government are being affected by the continuous evolution of complex multi-step supply chains, just-in-time distribution, first to market philosophy, as well as cost containment strategies.

• One example is the globalized and diversified drug supply chain, where: • the vast majority of drugs sold and consumed in Canada are imported,

including from emerging markets with immature regulatory systems (e.g., India, China, etc.).

• drugs imported into Canada originate from approximately 4,200 foreign manufacturing sites; and,

• the regulator is largely domestically focused, prescriptive regulatory authorities, and exercises regulatory oversight in reactive manner.

Evolving Regulatory Landscape Market forces, innovation, technology, consumer behaviour and expectations…

…continue to drive the evolving and dynamic environment in which HC’s regulatory C&E programs operate.

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Product Life Cycle

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Move too slowly, and regulators risk leaving the public vulnerable or falling out of step with market realities. Move too quickly, and we risk stifling innovation.

How can Health Canada become a more optimal regulator?

Regulatory Operations and Regions Branch (RORB)

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April 4, 2016

• Horizontal accountability

• Regional variation

• Dispersed C&E capacity

• Decentralized strategic and operational planning

A Branch Dedicated to Compliance and Enforcement

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Consolidating compliance and enforcement within a single branch…

…to enable Health Canada to adapt to the changing regulatory landscape.

• Vertical accountability

• National consistency

• Consolidated C&E capacity

• Centralized strategic and operational planning

Before Re-organization After Re-organization

RORB’s Guiding Principles

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Vision Statement To achieve regulatory excellence across the compliance and enforcement

continuum.

Mission Statement Lead compliance and enforcement and complementary scientific programs to

inform and protect Canadians from health risks associated with products, substances and their environment.

A new vision and mission for compliance and enforcement…

…marking Health Canada’s commitment to regulatory excellence.

• Regulatory Staff: ~1,000 across Canada

• Laboratories: 8 across Canada

• Regulated Products: 7 categories (cannabis, consumer products,

controlled substances, drugs, medical devices, pesticides, tobacco products)

• Domestic Inspections: ~14,000 annually

• Foreign Manufacturing Sites: ~5,000 (on target to inspect 40 this year)

RORB by the Numbers

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The scope of RORB’s regulatory duty spans seven product-lines…

…and the regulatory landscape is highly globalized and innovative.

New Organizational Structure

Assistant Deputy Minister’s Office

Policy and Regulatory Strategies

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Horizontal Clusters Delivery Clusters Program Clusters

Planning and Operations Laboratories

Consumer Product Safety,

Tobacco, and Pesticides

Controlled Substances

and Environmenta

l Health

Cannabis Health

Product Compliance

Medical Devices and

Clinical Compliance

Adapting to the Changing Environment

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GMP Transformation – Site Risk Profile

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The list of foreign sites selected for inspection is comprised of different categories of inspections. The foreign building inspection plan includes different categories such as: 1. foreign buildings selected based on a specified range of SRP scores; 2. foreign buildings of common interest with Trusted Regulatory Partners; 3. risk files (i.e., undergoing risk issues management); 4. foreign buildings requested to be inspected by importers; 5. foreign buildings selected for a targeted inspection (i.e., based on GMP

issues noted during domestic inspections and foreign paper assessments);

6. foreign buildings selected based on a partially random approach (e.g., low SRP with high number of importers);

7. foreign buildings subject to a supportive inspections for review bureau (e.g., as part of a new drug submission);

8. other categories.

GMP Transformation – Site Selection Criteria

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• When calculating the SRP score, some criteria may not have been found to be a statistically significant predictor.

• These “Impact criteria” may contribute to the risk of the foreign building, and/or be important intelligence information to prioritize and will impact the decision making process of selection.

• Example: If a foreign building has a High SRP score, but a Trusted

Regulatory Partner has scheduled an inspection, Health Canada can accept the outcome of this inspection (e.g. review through paper assessment) and utilize resources for other on-site inspections.

Cases vs. Groups* *cases relate to a single product, whereas groups relate to more than one product

Active Groups

Active Cases

0

200

400

600

800

1,000

1,200

1,400

1,600

Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep

Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2

15-16 16-17 17-18

Cases Received Cases Closed Groups Received Groups Closed

Active Cases

Active Groups

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Time to first action for as of September 14, 2017 • 97% of all cases first actioned within standard • 94% of Priority A cases first actioned within 7 (2 + 5) business days from assignment • 98% of Priority B cases first actioned within 40 (10 + 30) business days from assignment

Expanded Regulatory Scope – Drug Shortages

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Next Steps

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• Continue to enhance data analytics capacity.

• Increase reliance on risk intelligence to guide decision-making.

• Increase effectiveness through management control frameworks.

• Stabilize program funding through ongoing updates to service fees.

• Assess relevance, performance, and cost-effectiveness by identifying and reviewing key performance indicators.

• Strengthen and deepen existing partnerships with international

regulators or establish new partnerships.

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Thank you