So what: Presenting a foreign-approved indication as "reference information," or using language that suggests a dosing method not covered by the domestic approval, both violate this requirement. The approved scope is strictly the Japanese domestic approval — no geographic exceptions.

So why: Japan's regulatory approval evaluates efficacy, safety, and quality in the context of domestic clinical practice. Circulating unapproved information can prompt uses that have not been through that evaluation, exposing patients to risks the approval process was designed to prevent. Respecting the approved scope is the first line of defence for the safety framework established by regulators.

So what: Featuring a response rate prominently while burying serious adverse event rates in fine print, or reporting only the trial with the most statistically significant result when several comparable trials exist, both breach this requirement.

So why: Prescribers need to weigh benefit against risk in the same informational context. A presentation that leaves a strong efficacy impression while relegating safety information to the background distorts that risk-benefit comparison. Banning arbitrary selection preserves the informational symmetry that sound prescribing decisions require.

So what: Citing numbers from a conference abstract alone, presenting trial results that exist only in an internal database, or referencing proprietary analyses whose methodology is undisclosed — none of these meet the "demonstrable evidence" standard. Peer-reviewed original articles and regulatory approval review reports are the practical baseline for evidence in materials.

So why: Companies have an inherent incentive to conduct and cite analyses that favour their products. Requiring third-party-reviewed evidence moves the verification of information quality outside the company's own judgment, and places prescribers in a position where they can independently assess the credibility of what they are being told.

So what: A reference list at the end of a material may not be enough. When the data come from research that received company funding, the type and scope of that support (goods, money, how much, etc.) must be disclosed specifically. Data from external research that did not comply with applicable ethical guidelines cannot be used regardless of how favourable the results are.

So why: Multiple studies have documented that industry-funded research is more likely to yield positive results. Conflict-of-interest disclosure enables prescribers to calibrate the credibility of evidence for themselves. Barring non-compliant research protects both study participants and the scientific integrity of the data being relied upon.