"FY 2026 Meeting of Code Management Officers and Practitioners" Held
On September 18, 2026, the JPMA Code Compliance Committee held the “FY2026 Code Management Officers and Practitioners Meeting” according to the program below.A total of 184 participants (107 in-person and 77 online), primarily code management officers and code staff, attended from 68 member companies. The following is a summary of the meeting.
Program for the “FY 2026 Meeting of Code Management Officers and Practitioners”
| Part 1: For Code Practitioners |
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| Part 2: For code administration managers and practitioners |
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Part 1
Group Discussion
A group discussion was held for code compliance officers from various companies on the theme “Proper Management of Company-Sponsored (or Co-Sponsored) Seminars.”
Participants shared their companies’ initiatives and challenges regarding explanations provided when inviting speakers, preliminary meetings, slide reviews, on-site management, and post-event follow-ups. They also engaged in a lively exchange of ideas and points to note for ensuring the proper management of these seminars.
Part 2
Opening remarks
Kaoru Ouchi Chairperson, JPMA Code Compliance Committee
Chairperson Kaori Ouchi stated that the fundamental purpose underlying the codes, rules, and governance of pharmaceutical companies is to secure the trust of patients, healthcare professionals, and their families, and to contribute to the realization of appropriate medical care.She also explained that Code Management Officers and operational staff play a crucial role as the cornerstone of that trust; they are expected to accurately grasp industry trends and case studies, implement them within their own companies, and make recommendations to senior management as necessary.She further called on participants to take the knowledge and insights gained at this meeting back to their respective companies to help enhance trust in the industry as a whole.
Information Session by the Code Compliance Committee
Masato Wakai, Chairperson, JPMA Code Compliance Committee
Masato Wakai, Chairperson of the Working Committee, provided an explanation regarding “Measures Taken Following the Publication of the Report on the Survey of Sales Information Provision Activities” and “Measures Taken Following the Issuance of Notifications Concerning the Provision of Information Related to Clinical Trials, etc.”
Regarding the Report on the Survey of Sales Information Provision Activities, it was noted that the number of suspected violations in Reiwa 7 decreased significantly from the previous fiscal year, reflecting the effectiveness of the Guidelines for Sales Information Provision Activities and the ongoing efforts of each company.On the other hand, since cases such as the provision of unapproved information under the guise of requests from healthcare professionals and the dissemination of inappropriate information at company-sponsored lectures continue to be identified, he reiterated the request for strict compliance with the Guidelines for Sales Information Provision Activities, the accompanying Q&A, and the JPMA Code of Conduct.
Furthermore, in response to the Ministry of Health, Labor and Welfare’s notification issued in March of this year regarding the provision of information related to clinical trials, it was reported that the JPMA’s “Guidelines on Posting Content on Websites” (formerly “Guidelines on Posting Content on Homepages”) had been revised.We explained the comprehensive revision of the Q&A on clinical trial information and the creation of a new Q&A on providing information to patient groups and other organizations, and called on each company to ensure awareness among relevant departments, review internal regulations and screening procedures, and inspect existing websites and clinical trial information provided to patient groups.
Japan Pharmaceutical Regulatory Framework
Go Matsumura, Vice Chairperson, Code Compliance Committee, JPMA
Vice Chairperson Go Matsumura provided an explanation of the “Japan Pharmaceutical Regulatory Framework” prepared by the Global Code Compliance Subcommittee.
This tool systematically organizes the overall landscape of legal regulations and industry rules governing commercial activities in Japan’s pharmaceutical industry and was created as a common resource for explaining these matters to overseas employees and stakeholders.In particular, focusing on post-approval commercial activities, the content is designed to facilitate a structured understanding of the regulatory framework from the two perspectives of “provision of product information” and “transfer of value.”
In addition, explanatory scripts in both Japanese and English have been prepared, and it was noted that these should be utilized in various contexts, such as global training sessions and discussions with overseas stakeholders. Furthermore, it was stated that the document will be continuously updated based on feedback and requests from member companies.
About the JPMA Code Awareness Month
Daisuke Ishii, Working Member, JPMA Code Compliance Committee
Daisuke Ishii, a member of the Practical Affairs Committee, explained the initiatives for the FY2026 JPMA Code Awareness Month.
This year’s theme is “From Understanding to Action: Each of Our Actions Builds Trust.” He explained that this initiative takes a step beyond last year’s activities—which focused on understanding and disseminating the revised JPMA Code—and aims to translate that understanding into appropriate judgment and actions in daily work.
As part of these initiatives, in addition to paper and digital posters, new videos providing explanation on the purpose of Awareness Month and guidance on conducting workplace discussions were created.It was also explained that discussion materials have been prepared to help each workplace implement the initiative through four steps: “Review the JPMA Code,” “Identify risks,” “Consider preventive actions,” and “Post a declaration of commitment on the poster and put it into practice.”
The importance of putting the JPMA Code into practice in daily operations was emphasized, with each department and division recognizing the risks inherent in their own work and sharing preventive actions as a “declaration of commitment.”
Information from the Association
Yoshiyuki Ishida, Executive Director, JPMA
Yoshiyuki Ishida provided an explanation regarding the provision of information on unapproved and off-label uses related to gestational diabetes, as requested by the Japan Diabetes Society, the Japan Society for Diabetes and Pregnancy, and the Japan Society of Obstetrics and Gynecology.
Following confirmation with the Surveillance, Guidance, and Narcotics Control Division, it was announced that, provided the content falls within the scope described in the “Examples of Information Provision for Medical Fee Review,” presenters at seminars hosted or co-hosted by companies would not be considered to be engaging in inappropriate sales information activities when providing such information.
However, he also explained operational considerations, noting that companies are not permitted to proactively provide such information or create related slides; instead, presenters must explain that the use is unapproved or off-label and that it may be subject to review under insurance-covered medical care.
Special Lecture: "Survey Project on Activities to Provide Sales Information
Ryotaro Sakaniba, Senior Inspector, Surveillance, Guidance, and Narcotics Control Division, Pharmaceutical Affairs Bureau, Ministry of Health, Labor and Welfare
Chairman Ryotaro Sakaniba delivered a presentation on the “Sales Information Provision Activities Survey Project” and explained the survey results for Reiwa 7 and key case examples.
The survey results for Reiwa 7 reported that there were 6 cases where impropriety was suspected in monitor reports and 11 items where violations were suspected, representing a significant decrease from the previous year’s 18 cases and 23 items.While this suggests that information provision activities are becoming more appropriate due to the widespread adoption of the Guidelines for Sales Information Provision Activities and companies’ ongoing efforts, it was explained that “explanations lacking evidence” remained the most common issue, followed by “information that emphasized efficacy alone.”
Furthermore, the report provided explanations of specific cases, including explanations lacking evidence, defamation or slander of competitors’ products, references to unapproved indications and effects, and the provision of information that emphasized efficacy alone.Among these, regarding cases where speakers at company-sponsored lectures referred to unapproved indications and effects, it was emphasized that even if the speaker is a physician, such actions may constitute sales promotion activities by the company and, in some cases, may violate the prohibition on advertising unapproved pharmaceuticals under Article 68 of the Act on Pharmaceutical and Medical Devices.Furthermore, regarding cases of inappropriate information provision by pharmaceutical wholesalers, while it was acknowledged that the entity providing the information bears responsibility, the view was expressed that it is important for pharmaceutical companies—upon becoming aware that inappropriate content is being widely disseminated—to strive to correct the information, such as by disseminating information on proper use themselves.
Moving forward, pharmaceutical companies were urged to provide information that strikes a balance between efficacy and safety, as well as to appropriately disclose safety information, including Risk Management Plans (RMPs). In addition, a particularly strong warning was issued regarding the planning and operation of company-sponsored seminars, emphasizing the need for strict compliance with laws, regulations, and guidelines.
Acknowledgments and Closing Remarks
Yoshiyuki Ishida, Executive Director, JPMA
Yoshiyuki Ishida expressed his gratitude to Chair Ryotaro Sakaniba, who delivered a special lecture. He noted that while the number of suspected violations had decreased according to the Sales Information Provision Activities Survey Report,cases potentially in violation of Article 68 of the Act on Pharmaceutical and Medical Devices were reported, and he called on member companies to further improve the propriety of their information-provision activities.
He also urged member companies not to view such cases as problems exclusive to other firms, but rather to recognize them as issues that could occur within their own organizations, and to use this as an opportunity to review their organizational management and oversight systems and pursue continuous improvement.Furthermore, taking the “JPMA Code Awareness Month” in November as an opportunity, we once again emphasized the importance not only of understanding the JPMA Code and the Guidelines for Sales Information Provision Activities but also of putting them into practice in daily operations, and concluded with closing remarks.
(Megumi Muraoka and Junko Ota, Working Committee Members, Code Compliance Committee)