01The floods of generated materials ── only the making got faster

First, let us put into words what is happening now. By materials we mean the documents used to deliver information about prescription drugs to healthcare professionals and patients ── brochures, explainer slides, web pages, emails, video scripts, and the like, taken together. Traditionally, such materials were finished through repeated back-and-forth: a staff member wrote a draft, put it through internal review, made corrections, and submitted it again. Taking several weeks to complete a single piece was not unusual.

Generative AI shrank this drafting stage to minutes. So what happens? The volume of materials arriving at the review department goes up. Yet the time to verify each piece stays the same. Reading it, checking it against the statutes, tracing the citations, seeing whether it stays within the approved indication ── none of this gets shorter just because AI wrote the draft. Only the entrance got wider, while the exit stays the same width. So it clogs.

Here let us make clear what material review is. Material review is the process of verifying, before publication, that a material does not violate the Pharmaceutical and Medical Device Act (PMD Act), internal standards, or the guidelines for sales information provision activities. And a material is, ultimately, a document for information provision. The PMD Act places the proper conduct of information in sales information provision activities under Article 68-2. Matters of commerce ── price, stock, delivery time, ordering ── are not information to put in a material. That belongs to the domain where pharmaceutical wholesalers and hospital purchasing departments deal with each other, and it is a separate matter from the information provision done by materials or by MRs (= medical representatives). This dividing line will matter later as a fence for review.

02The three traps of mass production ── why "fast" turns into "dangerous"

That materials can be made fast and in bulk is not, in itself, a bad thing. The problem is that generative AI has habits peculiar to how it makes things, and when those multiply with sheer volume, the probability of slipping through review rises. There are three main traps.

Trap 01

Plausible falsehoods

Errors wearing a "real face"

Trials and citations that do not exist, indications that were never approved ── generative AI writes them with exactly the same confidence as the real thing. As we saw in Vol. 1, AI writes "the plausible continuation," so "the data you wish existed" slips in as if it were real.

Trap 02

The number of small deviations

"Minor" ones pile up

Seen one at a time, they are light ── a slightly inflated heading, a missing citation, an over-assertive turn of phrase. But the more pieces there are, the higher the chance that one of them sails through review. Numbers thin out the defenses.

Trap 03

Copying the same mistake

A "habit" spreads sideways

Give the same AI the same instruction, and the same habitual deviation is copied into every material. What would be one person's mistake in manual work is mass-produced all at once by AI. It is no longer a matter of fixing one place.

What the three traps share is that all of them are "perfect in appearance." A clearly odd material can be stopped by anyone in review. The danger is when a single sentence that casually states an indication beyond the approved range, or a single line attaching a nonexistent citation, sits naturally within a polished material. Claiming an indication beyond the approved range constitutes exaggerated advertising under Article 66 of the PMD Act ── yet that one sentence wears a face natural enough to skim right past.

03The three checkpoints ── a design where people do not read everything

So how do you review a stream of materials that only grows? The answer is not "people re-read everything." That clogs. Nor is it "hand everything to AI." That misses the traps. The realistic answer is to split review into three checkpoints and, after machines narrow things down, have people verify what matters.

The important point is that in none of the three do people read everything. Fit the frame at the entrance, let machines narrow at the middle, and at the exit have people verify only what matters. To keep the defenses up without slowing down, there is no choice but to narrow down where you verify. People's time is concentrated on what machines cannot pick up ── reading context, subtle assertions, misleading gaps.

04Combining guardrails ── freeing human eyes with machine fences

What supports the middle's first sieve is guardrails. A guardrail is a mechanical fence placed before the output reaches human eyes. In driving terms, it is the curb that physically pushes a car back when it drifts off the road. In material review, line up fences like these.

Do not mix up the PMD Act's three measures: the prohibition of exaggerated advertising is Article 66, the prohibition of advertising unapproved drugs and the like is Article 68, and the proper conduct of information provision in sales information provision activities is Article 68-2. Claim an indication beyond the approved range and it is Article 66; handle a product not yet approved and it is Article 68; the very manner of putting out the information is Article 68-2 ── even when AI drafts it, the measure you apply does not change. The concrete line for what counts as exaggeration is written in the commentary on the "Standards for Proper Advertising of Drugs and the Like" issued by the Director of the Surveillance and Guidance / Narcotics Control Division, Pharmaceutical Safety and Environmental Health Bureau, Ministry of Health, Labour and Welfare. The measure for prohibited words and expressions is drawn from there.

There is one more fence: the dividing line of the material itself. A material is a document for information provision, not a tool of commerce. Price, stock, delivery time, ordering, discount negotiation ── these are not information to put in a material. They belong to the domain handled by pharmaceutical wholesalers and hospital purchasing departments, separate from an MR's information provision. Yet when you have generative AI make a document, it sometimes mixes in unrequested promotional lines like "plenty in stock now" or "special price," thinking it is being helpful. Removing such intrusions is also the review fence's job.

The aim of letting machines take on the guardrails is to free human eyes. Detecting prohibited words and cross-checking citations are the machine's forte ── tirelessly and steadily done. Entrust that, and people spend their time on the judgments machines cannot pick up. Fences are placed not to replace people, but to move people to more important places.

05Tailoring for multiple audiences ── change the audience, change the measure

One of generative AI's fortes is tailoring. From a single source, it can make separate versions for physicians, for pharmacists, and for patients. What once took the labor of rewriting for each audience now comes out in parallel from a single instruction. Convenient. But there is a pitfall here. Change the audience, and the regulatory measure you apply changes too.

Patient- and general-public-facing materials call for particular care. Advertising prescription drugs to the general public is, as a rule, not permitted at all. The specialized descriptions allowed in materials for healthcare professionals do not pass in patient-facing ones ── and generative AI does not distinguish this difference automatically. Tailoring mechanically from the same source risks letting physician-facing expressions flow straight into patient-facing ones.

Materials for healthcare professionalsMaterials for patients / the general public
Assumes prescribing / dispensing specialists as readersAssumes readers without specialized knowledge
Can describe indications, usage, and clinical data in specialist termsAdvertising prescription drugs to the general public is, as a rule, not permitted
Review weighs the approved scope and citation accuracy heavilyReview weighs whether it stirs misunderstanding or anxiety, or asserts effects, heavily
Main risks are off-label indications and exaggeration (Article 66)Main risks are unapproved status and general-public advertising rules (Article 68)

The idea of changing how you provide information according to the audience is not a new one. In its 1988 "Ethical Criteria for Medicinal Drug Promotion," the World Health Organization (WHO) held that promotion should be accurate, fair, and substantiated, and called for consideration according to whether the reader is a prescriber or a member of the general public. Apply that old principle, as is, to generative AI's tailoring too. Being able to make it fast and being able to make it correctly for the audience are separate matters.

06Effect and limits ── AI up to the first sieve, judgment to people

Put this mechanism in place, and review does get faster. Detecting prohibited words, matching citations, cross-checking against the approved scope ── machines handle the first sieve tirelessly, and people need look only at what falls through. You can meet the rising volume without adding more human eyes. This is the effect.

But you need to look honestly at the limits.

Which way to tilt the sieve: what you most want to avoid in review is the miss that passes what should be stopped. So tilt AI's first sieve toward "send it to a person" when in doubt. Increase misses for the sake of speed, and review itself loses its meaning. What you entrust to AI is not the role of waving through "the clearly fine," but the role of gathering "the doubtful" for people.

07Connections to other chapters ── the measure of regulation, and the design of speed

The asymmetry this volume took up ── the "making side" and the "verifying side" ── connects to other chapters on this site. Read together, the place of material review comes into three dimensions.

Conclusion

Generative AI changed the speed of making materials by an order of magnitude. But the speed of verifying them has not changed. Leave this asymmetry alone, and one of two things happens: the review department clogs, or the checking goes lax. The answer this volume presented is simple ── stop having people read everything, and narrow down where you verify. Fit the frame at the entrance, let machines narrow at the middle, and have people verify what matters at the exit. Combine the three checkpoints with machine fences, and apply the PMD Act's three measures (exaggeration Article 66, unapproved Article 68, information provision Article 68-2) without mixing them up.

What must not be forgotten is this one point: what AI carries is only up to the first sieve. Judgment and responsibility remain with people to the end. Make the verifying process thicker by exactly as much as you can make faster ── think of the purpose of raising speed as freeing up time to put back into review, and you will not mistake the order. Next time, we step into a particularly troublesome adversary in this review ── how to find, with AI, the deviations that slip into materials. Exaggeration, off-label, missing citations. How far can a machine pick up errors that wear a plausible face?

Key Points ── three to take away
  1. Generative AI made it possible to produce materials in minutes, but the speed of the material review they must pass before publication has not changed. The asymmetry where only the making side gets faster clogs the review department. Mass production has three traps ── plausible falsehoods, the number of small deviations, copying the same mistake ── all of which slip in while "perfect in appearance."
  2. The answer is neither "people read everything" nor "hand everything to AI," but narrowing down across three checkpoints: entrance (embed the frame in the instruction), middle (the machine's first sieve), and exit (the final human review). Machine guardrails (matching the approved scope, verifying the existence of citations, detecting prohibited words, removing intruded commercial information) free human eyes and concentrate them on what matters.
  3. The measure review applies does not change even when AI drafts ── exaggeration is PMD Act Article 66, unapproved is Article 68, and the proper conduct of information provision is Article 68-2. The center of gravity of regulation also shifts depending on whether the audience is a healthcare professional or a patient / member of the general public. What AI carries is only up to the first sieve; to avoid misses, send it to a person when in doubt. Judgment and responsibility remain with people to the end.
Sources / References
  1. Ministry of Health, Labour and Welfare. Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (PMD Act), Articles 66, 68, and 68-2. (The respective articles on the prohibition of exaggerated advertising, the prohibition of advertising unapproved drugs and the like, and the proper conduct of information provision in sales information provision activities.)
  2. Director-General, Pharmaceutical Safety and Environmental Health Bureau, Ministry of Health, Labour and Welfare. On the Guidelines for Sales Information Provision Activities for Prescription Drugs. September 25, 2018, Yakuseihatsu 0925 No. 1 (applied from April 1, 2019; the primary source of the sales-information-provision guidelines).
  3. Director-General, Pharmaceutical Safety and Environmental Health Bureau, Ministry of Health, Labour and Welfare. On the Standards for Proper Advertising of Drugs and the Like. September 29, 2017, Yakuseihatsu 0929 No. 4 (the main notification of the proper advertising standards).
  4. Director, Surveillance and Guidance / Narcotics Control Division, Pharmaceutical Safety and Environmental Health Bureau, Ministry of Health, Labour and Welfare. On the Commentary and Points to Note Regarding the Standards for Proper Advertising of Drugs and the Like. September 29, 2017, Yakuseikanmahatsu 0929 No. 5 (the commentary showing the concrete line for exaggerated and prohibited expressions).
  5. World Health Organization. Ethical Criteria for Medicinal Drug Promotion. Geneva: WHO, 1988. (The ethical criteria for medicinal drug promotion; an international standard calling for accuracy and fairness in promotion and consideration according to the audience.)