Brief · Use case · Pharmacovigilance

Class Safety Action Outlook.

LiveOutlook

Project whether a regulator adds a class-wide safety warning for a drug class within two years, with the base rate and early signposts.

ProjectionA class-wide safety warning within 24 months

SettingOne named drug class

ExpertHead of Pharmacovigilance

Not askedA recommended action

LengthComprehensive

Class Safety Action Outlook is a ready-made use case for Pharmacovigilance. It ships under the Outlook template.

For pharmacovigilance leads reading a signal. You get the projected event and resolution test, the reference class of earlier class actions, a range, scenarios and the signposts that would fire first. Claims are cited or marked as gaps.

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The decision

Will the FDA or the EMA add a class-wide safety warning for a named drug class within 24 months, and how likely is it?

What the outlook examines

A class-wide warning follows a process with visible steps. The outlook tracks where the class stands in that process and says how rarely the end of it is reached.

Part of the outlook	What it asks	Where it looks
What each regulator publishes	FDA publishes drug safety communications in a chronological list. EMA’s Pharmacovigilance Risk Assessment Committee publishes meeting highlights, agendas and minutes.^{1U.S. Food and Drug Administration. Drug Safety Communications. Content current as of 15 September 2026.,2European Medicines Agency. Pharmacovigilance Risk Assessment Committee (PRAC).}	FDA’s Drug Safety Communications page and EMA’s PRAC page.
How signals are managed	The EU signal management process, overseen by the committee, and its requirements and guidance.^{3European Medicines Agency. Guideline on good pharmacovigilance practices (GVP): Module IX – Signal management (Rev. 1). EMA/827661/2011 Rev. 1. Legal effective date 22 November 2017.}	EMA’s GVP Module IX, revision 1.
What the flags can and cannot show	Disproportionality methods flag pairs reported more often than expected. A flag is a screening result.^{4Evans, S. J. W., Waller, P. C. and Davis, S. Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports. Pharmacoepidemiology and Drug Safety, 2001;10(6):483–486.}	The published evaluation of the proportional reporting ratio.

What the outlook does

No simple base rate. The outlook did not find a published rate for how often a class under review ends with a class-wide warning. The base rate section says so and builds a reference class from past communications for comparable classes, labeled as judgment.

Where the class sits now. The outlook reads the regulators’ public pages for signals, reviews and communications that already concern the class, and dates each. A class already under review has a different likelihood from one that is not.^{1U.S. Food and Drug Administration. Drug Safety Communications. Content current as of 15 September 2026.,2European Medicines Agency. Pharmacovigilance Risk Assessment Committee (PRAC).}

Signposts are public. A PRAC agenda item, a new communication for a member of the class, or a label change for one product are visible events. The outlook lists them as signposts, with where to check.^{1U.S. Food and Drug Administration. Drug Safety Communications. Content current as of 15 September 2026.,2European Medicines Agency. Pharmacovigilance Risk Assessment Committee (PRAC).,3European Medicines Agency. Guideline on good pharmacovigilance practices (GVP): Module IX – Signal management (Rev. 1). EMA/827661/2011 Rev. 1. Legal effective date 22 November 2017.}

Scenarios. At Comprehensive length the outlook sets out the scenarios: a class warning from FDA, from EMA, from both, or none, each with a likelihood.

Recommended length

Comprehensive

The future could go several ways. Comprehensive adds the table of scenarios with their likelihoods.

You can pick another length on the form. The other two stay available.

Assumptions the outlook checks

The outlook states the assumptions its likelihood rests on and names the weakest one. Examples for this question:

The regulators’ public pages show the signals and reviews that matter for the class.
The class is defined by the substances the outlook states.
No safety signal that is not public is already under assessment.

Standards, guidance and sources

Regulators’ own pages

FDA, Drug Safety Communications: a chronological list, current as of 15 September 2026.^{1U.S. Food and Drug Administration. Drug Safety Communications. Content current as of 15 September 2026.}
EMA, Pharmacovigilance Risk Assessment Committee (PRAC): meeting highlights, agendas and minutes.^{2European Medicines Agency. Pharmacovigilance Risk Assessment Committee (PRAC).}
EMA, GVP Module IX: Signal management (Rev. 1), in effect from 22 November 2017.^{3European Medicines Agency. Guideline on good pharmacovigilance practices (GVP): Module IX – Signal management (Rev. 1). EMA/827661/2011 Rev. 1. Legal effective date 22 November 2017.}

The decision practice behind the memo itself is on the template page.

What gets flagged

Any likelihood that rests on judgment because no base rate exists, any signal that is not public, and any class edge case.

What arrives

The projection
Starting point and base rate
What is already in motion
The most likely path
Scenarios
What would change it
Signposts
Confidence, and where it is weakest

What it will not do

It does not predict with certainty or recommend an action. The likelihood carries a range, confidence is stated separately, and a Decision Memo uses the outlook as an input.

It is not a pharmacovigilance assessment and it does not say whether a signal is real.

It does not predict with certainty. A likelihood is a statement about the evidence, with a range, and the outlook says how sure it is separately.

It does not make a base rate from nothing. Where no reference class exists, the base rate table says so and the likelihood is labeled analyst judgment.

It does not recommend an action. A Decision Memo takes the outlook as an input.

References

[1] U.S. Food and Drug Administration. Drug Safety Communications. Content current as of 15 September 2026. Read on 9 October 2026.
[2] European Medicines Agency. Pharmacovigilance Risk Assessment Committee (PRAC). Read on 9 October 2026.
[3] European Medicines Agency. Guideline on good pharmacovigilance practices (GVP): Module IX – Signal management (Rev. 1). EMA/827661/2011 Rev. 1. Legal effective date 22 November 2017. Status and scope as given in EMA’s listing found by search; the module was not read in full.
[4] Evans, S. J. W., Waller, P. C. and Davis, S. Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports. Pharmacoepidemiology and Drug Safety, 2001;10(6):483–486. Read from the abstract as summarized in search excerpts.

Links checked 9 October 2026

These are the sources the template drew on. None of their authors or issuers has reviewed it.

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