SURVEY PROGRAM FOR SALES INFORMATION PROVISION ACTIVITIES

1. Purpose and operation of the program

The program seeks to identify inappropriate prescription-drug sales information activities at an early stage and promote appropriate information provision through publication of cases, awareness raising and administrative guidance where necessary. Advertising monitoring began in FY2016. In October 2019, the program expanded to receive general reports from healthcare professionals outside designated monitor institutions. The name changed from a monitoring program to a survey program in FY2024.

In FY2025, the program comprised monitor surveys, collection and evaluation of general reports, education for healthcare professionals, review of medical journals and pharmaceutical-company websites, and case review meetings. Monitors broadly report activities that raise questions or concerns. The secretariat organizes the information and seeks clarification as needed; the review meeting evaluates each case. MHLW makes the final administrative judgment, taking account of the meeting’s opinions, and determines appropriate action.

Source: FY2025 report, pp. 1–5.

2. Main reference materials used in the FY2025 report

The report identifies the following legislation, notices and industry standards among the materials used by monitor institutions and the secretariat.

• Articles 66–68 of the PMD Act and the Standards for Fair Advertising Practices for Drugs and Related Products: reference materials addressing false or exaggerated advertising, advertising restrictions for medicines intended for designated diseases, and advertising of unapproved products.
• JPMA guidelines for preparing prescription-drug product information brochures and related materials: an industry standard for preparing promotional materials. The report describes revisions through October 2023. Review considerations include approved indications and dosage, accurate data, graph presentation and balanced citation of source literature.
• MHLW guidelines on prescription-drug sales information provision activities and related Q&As: materials concerning advertising and similar activities. The report discusses the September 2018 guidelines and related Q&As, including Q&A No. 4 issued on February 21, 2024.
• Earlier annual reports and PMDA review reports: materials for examining previous cases and the assessment made when a product was approved.

Sources: pp. 13–21 (main reference materials) and pp. 5–6 (materials introduced to monitors).

3. FY2025 findings

(1) Report counts

These are cumulative counts. They do not represent numbers of people, distinct products after deduplication, or confirmed legal violations. More than one suspected-violation item may relate to a drug. Monitor and general reports have different reporting periods and collection methods and should be read separately.

Sources: p. 22, Table 9 (monitor reports) and p. 25, Table 13 (general reports). Item classifications have been added or amended across years, so simple comparisons of annual item totals require care.

(2) Suspected-violation items and their shares

Among monitor reports, explanations without supporting evidence were most common (4 items, 36.4%), followed by emphasis on efficacy alone (2 items, 18.2%). Among general reports, presentation of unapproved indications or dosage and administration was most common (5 items, 41.7%).

Multiple categories could be reported. Percentages use 11 suspected-violation items for monitor reports and 12 for general reports as their respective denominators; they are not percentages of all reports or of drug counts. Rounding may prevent displayed percentages from totaling 100%. Category names have been abbreviated by this site.

Sources: p. 23, Table 10 and p. 26, Table 14.

(3) Information channels in cases with suspected violations

Monitor reports (Table 11):

• Direct face-to-face contact with company personnel: 3 (50.0%)
• Online/Web individual meetings with company personnel: 1 (16.7%)
• Online/Web group meetings within the institution with company personnel: 1 (16.7%)
• Other: 1 (16.7%)

General reports (Table 15):

• Oral explanations by company personnel: 3 (37.5%)
• Printed materials provided by company personnel: 1 (12.5%)
• Data shown by company personnel and taken away: 1 (12.5%)
• Other: 5 (62.5%)

Both tables allow multiple responses; only categories with at least one response are listed here. Percentages use the cumulative drug counts with suspected violations: 6 for monitor reports and 8 for general reports. The general-report entries above sum to 10 and their shares to 125.0% because multiple channels could apply to the same case. The two reporting systems use different channel classifications, limiting direct comparison.

Sources: p. 24, Table 11 and p. 27, Table 15. The monitor-report narrative on p. 23 lists one email/telephone instance, whereas Table 11 lists zero in that category and one online/Web individual meeting. The summary above follows the figures and categories in Table 11.

(4) Drug categories with suspected violations

Monitor reports: other central nervous system drugs, ophthalmic drugs, psychotropic drugs and vaccines. The report identifies multiple reports involving the first two categories and states that all monitor-report drugs concerned were originator products.

General reports: other respiratory drugs, vaccines, metabolic drugs not elsewhere classified, other antineoplastic drugs, other biological products, gout treatments, thyroid/parathyroid hormone preparations and unapproved drugs.

The report also states that all 14 general reports concerned originator products rather than generics (printed page 25).

Categories and ordering follow the report. Sources: p. 24, Table 12 and p. 27, Table 16.

(5) Trends and issues highlighted by the report

• Fewer reports and recognition of improved practices: cumulative drug counts in reports raising concerns fell from 18 to 9 for monitors and from 16 to 14 for general reports compared with the previous year. The report recognizes wider understanding of the guidelines and proactive provision of risk and safety information. General-report drug counts with suspected violations rose from 7 to 8, so the decrease did not apply to every measure.
• Balance between efficacy and safety: concerns remain about omission of safety information because presentation time is short and insufficient information on risk management plans (RMPs). The report calls for thorough application of the guidelines’ principles.
• Changing information channels: the report highlights online meetings, information sent to individuals and information from wholesale-company personnel. It also identifies concerns where a presentation is framed as a response to healthcare professionals’ requests while the company appears to have arranged it as a coordinated sequence.
• Company-sponsored lectures: presentations commissioned from external physicians may constitute company sales information activities or advertising. The report calls for careful management and advance review of explanations involving unapproved indications, including differences between overseas and Japanese approvals.

This section summarizes the report’s conclusions. Source: pp. 53–56 (main findings and requests to pharmaceutical companies).

Author’s note on interpreting the figures: Report counts cannot establish a violation rate for sales information activities as a whole.