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Guidance and Guardrails is where you configure the regulatory compliance framework for your agent. These settings ensure your agent stays within approved boundaries, uses appropriate terminology, and handles sensitive topics correctly — all critical requirements in pharmaceutical and healthcare communications.
Access these settings by selecting an agent from the Agents list and clicking the Guidance tab.

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Primary configuration

Start by defining the fundamental regulatory context for your agent.

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Therapy type

Select the type of therapy or treatment your agent supports:

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Jurisdiction

Choose the regulatory jurisdiction that applies to your treatment or therapy area:

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Primary audience

Confirm the intended audience for this agent:
  • Patient — General public and consumers
  • HCP — Healthcare professionals
  • Mixed — Both patients and healthcare professionals
The primary audience is typically set when you create the agent, but you can confirm or adjust it here. This selection influences which compliance rules and guardrails are applied — for example, the Patient Query Handling section appears for Patient and Mixed audiences.

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Therapeutic classification

The classification options depend on the jurisdiction you selected. Each classification carries specific regulatory implications that affect how your agent communicates.
For therapeutic products regulated by the TGA, select the appropriate schedule:
Schedule 4 (Prescription Only) medicines have significant advertising restrictions under TGA regulations. In most cases, these products cannot be promoted directly to consumers. Your agent’s guardrails will be configured accordingly.

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Diagnostic test classification

If your therapy type is Diagnostic, additional classification fields appear.

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Test type

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Test purpose

You can also specify whether the test requires an HCP order and whether genetic counseling is required.

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Patient query handling

For agents with a Patient or Mixed audience, you control how the agent handles each category of patient question. Six categories are available: Each category can be set to one of three behaviors:
  • Block — The agent declines with a message you can customize per category.
  • Auto-respond — The agent answers within its compliance boundaries.
  • Escalate — The query is forwarded to a configurable email address, and the user is told their question has been passed on.
Most patient-facing agents block or escalate Dosing & administration and Symptom & medical advice queries, directing patients back to their healthcare provider.

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Disease, indications, and terminology

This section defines the approved clinical language your agent may use.

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Approved disease references

List the diseases and conditions your agent is permitted to discuss. Only diseases listed here will be referenced in responses — the agent will avoid discussing conditions outside this list.

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Approved indications and claims

Define the specific indications and claims that have been approved for your treatment or medicine. These are the statements your agent is authorized to make — for example:
  • “Indicated for the treatment of moderate to severe plaque psoriasis in adults”
  • “Reduces the frequency of migraine headaches in patients with episodic migraine”
Be precise with your approved indications. Copy these directly from your approved labeling, prescribing information, or regulatory submission to ensure accuracy and avoid introducing unapproved language.

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Terminology overrides

Define custom terminology the agent should recognize and use correctly — acronyms, brand names, and context-specific terms. This helps the agent interpret domain shorthand your audience uses and respond with your preferred wording.

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Prohibited terms

The RoseRx Platform allows you to define terms and phrases that your agent must never use. Prohibited terms are organized into five categories:
Common terms that could be misleading or non-compliant in a healthcare context.Default examples: “cure”, “miracle”, “breakthrough”, “guaranteed”, “100% effective”
Terms relating to biological processes or mechanisms that may overstate the product’s action.Default examples: “kills bacteria”, “destroys cancer cells”, “eliminates the virus”
Claims that compare the product to competitors or overstate its performance.Default examples: “best in class”, “superior”, “outperforms”, “number one”
Phrases that could be interpreted as providing direct medical advice.Default examples: “you should take”, “stop taking your medication”, “this will help you”
Add any additional terms specific to your medicine, organization, or regulatory requirements.
Each category comes with sensible default terms. Review these defaults carefully and add any additional terms specific to your medicine or therapy area and the regulatory environment in which it operates.

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Approved alternatives

For each prohibited term, you can map an approved alternative — a compliant phrase the agent should use instead. When the agent encounters a situation where it might use a prohibited term, it substitutes the approved alternative automatically.
Map as many prohibited terms to approved alternatives as possible. This helps the agent maintain natural, fluent responses while staying compliant.

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Off-label content policy

Configure how your agent responds when a conversation moves into off-label territory — that is, when a user asks about uses, dosages, or populations not included in the approved labeling. You can also maintain structured lists of on-label and off-label indications to help the agent detect when a conversation moves into off-label territory.
Off-label content policies have significant regulatory implications. Consult your regulatory and medical affairs teams before selecting a policy. In most cases, Block or Redirect is the safest choice for patient-facing agents.

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Best practices

  • Start with stricter settings — It’s easier to loosen guardrails after review than to tighten them after a compliance issue
  • Review default prohibited terms — The defaults are a solid starting point, but every product has unique regulatory considerations
  • Align with your MLR process — Ensure your guardrail configuration has been reviewed by your Medical, Legal, and Regulatory (MLR) team
  • Test thoroughly — Use the Batch Testing feature to verify your guardrails work as expected before publishing