MSA Guidelines Q&A — Hub | MSA Guidelines Q&A | Advertising Regulation in Japan (Promotional Material Review) and Artificial Intelligence

What you'll learn

MHLW issued the MSA Guidelines Q&A across four separate administrative notices — not as a single document — and this hub consolidates all 80 questions in one place.
Part 2 covers unapproved and off-label drugs, the highest-compliance-risk topic in the entire Q&A series.
Part 3 addresses the interview form specifically: MR documentation obligations are treated as a distinct operational category, separate from advertising or promotion rules.
Part 4 covers inter-company product comparisons, which carry their own restriction risks under the Guidelines and are not governed by the same rules as general promotional materials.
Each Q&A is reproduced verbatim from the official administrative notice, then paired with so-what / so-why commentary explaining the operational impact for MR activities.

To support the operation of the Guidelines on Medical Drug Sales Information Provision Activities (MSA Guidelines), MHLW issued Q&A in four administrative notices (Parts 1–4). This hub organizes all 80 questions into four parts, reproduces each one faithfully, and adds a so-what / so-why commentary. Part 1 covers general matters, Part 2 unapproved/off-label drugs, Part 3 the interview form, and Part 4 comparison with other companies' products.

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MSA Guidelines Q&A — Hub

Q&A Part 1 +39

▸ Part top (commentary & cases)Q1 Is information provision under GCP/GPSP/GVP outside the scope?Q2 Does 'expecting sales promotion' equal customer inducement?Q3 Is pre-approval communication by clinical development teams exempt?Q4 Can internal rules separating MA/MSL from sales avoid the Guidelines?Q5 Is disease awareness activity under proper advertising standards exempt?Q6 Is information provision to contracted healthcare professionals exempt?Q7 Are external expert lectures at company-sponsored events covered?Q8 Does the Guideline apply to non-sales employees' activities?Q9 Can review reports justify off-label information provision?Q10 Does the approved-scope limit apply only to own products?Q11 May off-label adverse event data be shared as safety alerts?Q12 Is balanced provision including unfavorable information required?Q13 Must peer-reviewed articles also allow objective evaluation and verification?Q14 May pre-Clinical Trials Act external studies be cited in materials?Q15 May non-Japanese external studies outside the Clinical Trials Act be cited?Q16 Is best-effort confirmation of ethical guideline compliance sufficient?Q17 If a paper lacks a COI disclosure, can companies record only what they know?Q18 What specific negative information must be provided?Q19 Can review and monitoring be handled by separate organizational units?Q20 Can sales staff serve as monitoring practitioners in the supervisory department?Q21 Can the Medical Affairs department serve as the supervisory department?Q22 Can the supervisory department be composed of multiple existing departments?Q23 Can the review and supervisory committee be placed outside the supervisory department?Q24 What degree of independence is required for a person "independent from the company"?Q25 Can an external expert who reviews materials also serve as the independent member of the committee?Q26 Does a person in a global organization outside the Japanese president's authority qualify as independent?Q27 Can the review and supervisory committee's functions be outsourced to an external body?Q28 What does it mean in practice for management to reflect promotional conduct in employee evaluations?Q29 Is there a recommended frequency for monitoring and committee reporting?Q30 Are there mandatory items that must be covered in the SOPs?Q31 Is a simplified record sufficient for verbal explanations during visits?Q32 Is there a recommended retention period for business records?Q33 Is there a prescribed method for publicizing the complaints contact externally?Q34 Can existing customer inquiry channels be repurposed as the complaints contact?Q35 Can MRs provide information on unapproved or off-label drugs?Q36 Is there a recommended retention period for records on unapproved/off-label drug information?Q37 Do the Guidelines apply to media seminars and press releases?Q38 What bodies are covered by the term "related associations"?

Q&A Part 2 +28

▸ Part top (commentary & cases)Q1 Scope of off-label/unapproved drug information that may be provided on request Q2 Scope of information on overseas indications/dosages not approved domestically Q3 Providing information on indications/dosages whose approval was revoked after re-evaluation Q4 Scope of clinical trial data that may be provided for unapproved/off-label drugs Q5 Providing information on pediatric use not explicitly described in the package insert Q6 Scope of development status information (clinical trial information) for unapproved drugs and new indications Q7 Providing unapproved quality information such as single-dose packaging stability and compatibility Q8 Providing information on simple suspension method not covered by approval Q9 Whether pre-prepared response documents for frequently requested off-label information are permissible Q10 Whether a treatment guideline containing off-label information may be provided Q11 Whether published post-marketing surveillance results containing unapproved dosage information may be provided Q12 Whether a peer-reviewed original article containing off-label information may be provided Q13 Whether companies may proactively provide off-label information based on a healthcare professional's known area of interest Q14 Whether information provided to one requesting physician may be distributed to other non-requesting physicians or pharmacists Q15 Whether off-label information may be proactively provided to physicians with prior use experience Q16 Responding to requests during in-person discussions with healthcare professionals Q17 Use of unapproved drug data in internal development meetings attended by contracted physicians Q18 Providing unapproved drug information to healthcare professionals for co-authoring academic articles Q19 Precautions when providing off-label information orally by telephone at a medical information center Q20 Providing information to additional healthcare professionals who join an ongoing session Q21 Whether to answer an off-label question publicly in a multi-physician departmental briefing Q22 Whether information may be provided to another staff member when the requesting physician or pharmacist is absent Q23 Responding to requests for off-label information at an academic conference exhibition booth Q24 Whether attendance at an overseas affiliate's lecture constitutes information provision by the Japanese parent company Q25 Whether Medical Affairs employees may present trial data at academic conferences Q26 Providing information on indications approved only for the originator drug but not the generic (gap indications)Q27 Scope of clinical trial information that may be provided to patient organizations upon request

Q&A Part 3 +2

▸ Part top (commentary & cases)Q1 May stability data for simple suspension/crushing be included in the Interview Form for provision?

Q&A Part 4 +15

▸ Part top (commentary & cases)Q1 Can information on competing products or comparative data be provided when requested by physicians or pharmacists?Q2 Can comparative information drawn from package inserts, IFs, or treatment guidelines be provided?Q3 Can comparative efficacy information be provided when requested?Q4 Can efficacy comparative data from conference presentations not yet published as papers be provided?Q5 Can a comparative efficacy table be provided when specifically requested?Q6 Can comparative safety (adverse event) information be provided when requested?Q7 Can comparative data on contraindications, precautions, interactions, or specific adverse events be provided when requested?Q8 Can switching dose information from a competing product to one's own, drawn from unpublished conference data, be provided?Q9 Can comparative drug pricing information be provided when requested?Q10 Is comparative information completely prohibited when no request is made by physicians or pharmacists?Q11 Can off-label use information be provided on the spot when requested in real time?Q12 Can the latest conference presentation data also be provided as off-label use information?Q13 Can a treatment guideline containing information on domestically unapproved drugs be provided when requested?Q14 Can information confirming that off-label use is listed on public government/insurer websites be provided?

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