Intermediate-gate decision criteria — "submit" / "send back" / "hold"

01What the Intermediate Gate Is — The Door Before Internal Review

A piece of promotional material passes several checkpoints before it reaches the public: the vendor's own quality control, the owner's receipt and verification, the company's formal material review (sign-off by legal, regulatory, and medical), and post-release monitoring where needed. The "intermediate gate" this issue addresses sits before that third formal review. It is the door where the owner, having completed verification, decides whether the deliverable may go up to internal review.

It must not be confused with formal material review. Formal review is the final judgment of the organization's approval body, and its record is subject to audit under the Pharmaceutical and Medical Device Act and the sales information provision guideline. The intermediate gate is one step upstream — a readiness call made on the owner's (or brand team's) own responsibility about whether the material is fit to be reviewed. Whatever passes here goes up. The gate is therefore the owner's distinctive duty to provide a first-line guarantee of the quality of material that reaches the review body.

02Why Three Branches — A Binary Breaks the Floor

Make the gate a binary "send up / don't send up" and the floor distorts every time. Because "don't send up" effectively means "kick it back to the vendor to remake," deadline pressure tips even minor gaps toward "send up." Conversely, an over-cautious owner returns to the vendor even cases that a little more information would resolve, draining the relationship. A binary bends to the judge's psychological cost, and the bar drifts from person to person.

So split the decision into three: Pass (send to internal review), Return (send back to the vendor to fix), and Hold (wait in the owner's hands for additional information or confirmation). The third branch matters most. When the problem lies not in the vendor's production quality but in the owner's missing information or unsettled internal matters, returning it to the vendor is misdirected. Holding Hold as its own branch lets the owner route by where responsibility actually sits.

03The Non-Compensatory Rule — No Minor Virtue Buys Off a Major Defect

The heart of this gate is that it is non-compensatory. A superb design or scrupulously accurate citations do not offset a regulatory-critical defect. You do not pass on a total score; rather, if even one critical item is tripped, no amount of strength elsewhere yields a Pass. That is the decisive break from deduction- or addition-based scoring.

To make the rule work, split verification items into two layers. The critical layer (any single NG blocks Pass) and the improvement layer (compatible with Pass, but recorded). The critical layer holds: departure from the approved range (indication, efficacy, dosage), §66 exaggeration or misleading superiority, §68 pre-approval advertising, reference to unapproved or off-label use, omission or understatement of adverse reactions and contraindications, and fabricated or altered sources. None of these can be bought back with points.

04Criteria for the Critical Layer — Where a Trip Means Stop

Tie the critical layer directly to statute and standard. Banish the vague "somehow uneasy"; only when you can name which clause of which norm is touched does an item qualify as critical. If judges declare "critical" on subjective hunches, Holds and Returns swell and the floor stalls.

Check the approved range against the structure of the Act and the Standards for Fair Advertising, and the validity of information provision against the Sales Information Provision Guideline. Misciting the article voids the judgment itself — exaggeration is §66, pre-approval is §68, the duty of effort in information provision is §68-2; do not conflate them.

05Return vs. Hold — Decide by Where Responsibility Sits

Once a critical defect is found, whether it becomes a Return or a Hold turns on which side caused it. If the cause lies in the vendor's production, Return; if it lies in information the owner failed to supply or in unsettled internal matters, Hold. Get this wrong and you either force a blameless vendor into a fix, or dump homework the owner should carry onto the vendor.

1. Route to Return when: the defect is fixable within the brief and materials given to the vendor — miscited sources, invented wording beyond the approved range, missing mandatory statements in layout. The subject of the fix is the vendor.
2. Route to Hold when: the fix needs additional information or a judgment from the owner. Example — the basis data for a comparison claim is not yet cleared internally, the product's approval status is under review so advertisability is undecided, or interpretation of the internal Code of Practice differs across departments. The subject of the fix is the owner.
3. When both are entangled: resolve the owner side first via Hold, then hand the settled information to the vendor before Returning. Reverse the order and the vendor reworks again and again.

The sister series Production Quality Management covers vendor-side quality control, but a Return's effectiveness depends on the vendor's capacity to fix. Telling the vendor concretely "which clause of which norm was touched" at the moment of Return is the precondition for triggering the sister side's correction flow correctly.

06The Decision Template — A Three-Way Call That Leaves a Record

The decision must not be settled in a spoken word or a one-line email. Capture it in a record format that can later explain, at material review or audit, "why was this sent up in this state." Below is the minimum set of fields for the intermediate gate's decision record.

07Handling Borderline Cases — Don't Pass Gray on Nerve

The roughest territory in practice is gray: "not clearly critical, but not reassuring either." Tipping this toward Pass on the judge's nerve or deadline pressure is what costs the most later. As a rule, route gray to Hold, settle the deciding facts, and re-judge. Let passing gray become routine and the gate becomes a formality.

Record the basis for borderline calls connected to external norms wherever possible. Cite the relevant passages of the JPMA Code and JPMA Creation Guide, and the interpretations in the MSA-G Q&A, to leave "why we judged it gray and why we held it." Reproducibility of the same conclusion across different judges is the condition for keeping the gate from becoming person-dependent.

08Operating Discipline — Hold the Quality Without Losing Speed

A non-compensatory gate, being strict, draws pressure from the floor that it is "slow." But the slowness is usually a stall on gray calls or hesitation over the Return/Hold split. Both can be absorbed by writing the criteria down and standardizing verification items in the upstream receipt flow (Issue 3, Receipt Flow). It is thinking up the items for the first time at the gate that makes it slow.

Fix three points of operating discipline. First, the critical layer is identical regardless of judge — open it to individual discretion and non-compensation collapses. Second, every Hold carries a deadline so nothing rots in neglect. Third, the decision record is kept in a form the downstream formal review can reference, so review need not re-scan the points the gate already examined. The series' closing issue on documentation (Issue 10, Documentation (in preparation)) covers how to turn these gate records into an organizational asset.

The intermediate gate is where the owner most concretely exercises the series' core — "production was outsourced, responsibility was not." Rather than passing the vendor's output through untouched, the owner makes the call — Pass, Return, or Hold — as their own judgment and leaves their name on the record. Holding this single door non-compensatory is how the owner's hand sustains the quality of material that reaches the public.