Held the "2025 Meeting of Code Administration Managers and Practitioners

The Pharmaceutical Manufacturers Association of Japan (PMAJ) Code Compliance Promotion Committee held the "2025 Meeting of Code Administration Managers and Practitioners" on September 17, 2025, in accordance with the following program. A total of 199 people, mainly code management officers and code practice managers from 69 member companies, attended the meeting. The following is a summary of the meeting.

The venue  

Program of the "FY2025 Meeting for Code Administration Managers and Practitioners

Moderator: Mr. Toshiyuki Yamano, Practice Committee Member, Code Compliance Promotion Committee, Pharmaceutical Manufacturers Association of Japan

Part 1: Group Discussion for Code Administration Officers

Theme: "Initiatives for Appropriate Marketing Information Provision Activities - Appropriate Operation of Company Sponsored (Co-sponsored) Lectures

Part 2: For Code Administration Managers and Practitioners

  1. Opening remarks

    Kaoru Ouchi, Chairperson of the Pharmaceutical Association of Japan (PAK) Code Compliance Promotion Committee

  2. Code violation action case studies

    Hiroaki Mizoguchi, Practice Committee Member

  3. Revision of the Pharmaceutical Association of Japan Code

    Masato Wakai, Chairperson, Practice Committee

  4. Measures for the month to promote understanding of the Pharmaceutical Association of Japan (PAK) Code

    Hyoue Kawai, Practice Committee Member

  5. Special lecture on "Survey Project on Activities to Provide Sales Information

    Taichi Shinohara, Chief, Supervisory Guidance and Narcotics Control Division, Pharmaceutical Affairs Bureau, Ministry of Health, Labour and Welfare

  6. Acknowledgments

    Mr. Yoshiyuki Ishida, Executive Director, Pharmaceutical Manufacturers Association of Japan

Part 1

Group Discussion

The participants were divided into eight groups and exchanged opinions on the theme of "Efforts for appropriate marketing information provision activities - Appropriate operation of company-sponsored (co-sponsored) lecture meetings". In this opinion exchange, with the aim of effectively guaranteeing the appropriate operation of lectures, discussions were held on the devising of sufficient explanations at the time of role requests, prior meetings, slide reviews, and so on.

Part 2

Opening remarks

Kaoru Ouchi, Chairperson of the Pharmaceutical Association of Japan (PAK) Code Compliance Promotion Committee

Ms. Kaoru Ouchi, Chairperson of the Pharmaceutical Manufacturers Association of Japan (PMAJ) Code Compliance Promotion Committee, made the following comments in her first speech: "I believe that all of you here are the key players in maintaining and promoting compliance systems at your companies. I know that you see compliance as an obligation, but I believe that you can achieve greater results by promoting it with a sense of fulfillment," she said. I believe that this will enhance the value and credibility of Japanese pharmaceutical products, reassure patients and their families, and contribute to the realization of patient-centered medicine. I hope that today's meeting will be a meaningful opportunity to exchange information and build relationships with colleagues who share the same objectives," he said in his opening remarks.

Cases of Code Violation Measures

(Hiroaki Mizoguchi, Practice Member, Code Compliance Promotion Committee, Pharmaceutical Manufacturers Association of Japan)

Mr. Hiroaki Mizoguchi, a working member of the Pharmaceutical Association of Japan (PAK) Code Compliance Promotion Committee, explained the following points

  1. Concept of the measures taken by the Pharmaceutical Manufacturers Association of Japan

    In the "Regulations on Measures against Violations of the Pharmaceutical Association of Japan Code of Practice," the term "measures" is defined as a request by the Code Compliance Promotion Committee to the violating company for voluntary improvement. In other words, the JCPA does not impose sanctions on companies that violate the Code, but focuses on the efforts of the company to improve. The committee reaffirmed that the level of action is determined based on the two axes of "whether or not the violation is minor" and "whether or not the violation has been stopped and/or measures have been sufficiently taken to prevent recurrence" at the deliberation stage.

  2. Case Studies of Actions Taken by the Pharmaceutical Manufacturers Association of Japan

    The first case is "the use of personal information for purposes other than the intended use without the consent of medical personnel, and the second case is "the use of personal information for purposes other than the intended use without the consent of medical personnel, and the use of personal information for purposes other than the intended use without the consent of medical personnel, and the use of personal information for purposes other than the intended use without the consent of medical personnel. The second case was "an inappropriate lecture containing recommendations for unapproved use and slander and defamation of other companies' products.

  3. Preventing the Erroneous Dissemination of Information on In-House Drugs Prior to Approval

    Since similar cases continued to occur even after the issuance of the notice in 2023 and the request for reemphasis at the plenary session in 2024, we reminded the member companies that even in cases caused by the negligence of the outsourcing company, the outsourcing company cannot escape responsibility and to take necessary actions (thorough understanding, inspection, etc.) to the relevant departments both inside and outside of the company. The revised policy includes the following points.

Revision of the Pharmaceutical Association of Japan Code

Masato Wakai, Chairperson of the Code Compliance Promotion Committee, Pharmaceutical Manufacturers Association of Japan

Mr. Masato Wakai, Chairperson of the Pharmaceutical Association of Japan Code and Compliance Promotion Committee, explained about the Pharmaceutical Association of Japan Code of Practice (hereinafter referred to as the "Pharmaceutical Association of Japan Code") revised in May 2025 as follows

  1. Key Points of the Revision

    Two key points of the revision were the revision of the "definition of promotion" and the revision of the "Code of Conduct for MRs" to "Basics of Promotion Activities. The definition of "promotion" was defined as a wide range of activities, including sales promotion, consistent with the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) Code of Practice and Guidelines for Sales Information Provision Activities. The reason for the change from "MR Code of Conduct" to "Basics of Promotional Activities" is that any "director or employee of a member company" can be responsible for promotional activities, not just MRs, if they engage in activities that fall under the definition of promotion. The revised definition clarifies that not only MRs but also any "director or employee of a member company" can be a promoter of promotional activities.

  2. Reflection in the in-house code

    The committee also requested member companies to cooperate in a survey to be conducted by the Code Compliance Promotion Committee to ascertain the status of member companies' compliance with the revised Pharmaceutical Affairs Association (PAA) Code and to identify any questions that may arise. We also asked member companies to cooperate in a questionnaire conducted by the Code Compliance Promotion Committee to ascertain the status of compliance with the revised Pharmaceutical Affairs Association (PAA) Code and any questions they may have.

(5) Measures for the Month to Promote Understanding of the Code

Hyoue Kawai, Practice Committee Member, Code and Compliance Promotion Committee, Pharmaceutical Affairs Bureau, Ministry of Health, Labour and Welfare

Mr. Hyoue Kawai, Practice Committee Member of the Pharmaceutical Association of Japan Code Compliance Promotion Committee, explained the measures to be taken during the "Pharmaceutical Association of Japan Code Understanding Promotion Month" ("Understanding Promotion Month") to be held in November 2025.

He explained that the theme for FY2025 has been set as "Code Revision 2025! - Our New Standard" with the aim of spreading the Pharmaceutical Association of Japan Code, which has been revised for the first time in six years, to all member companies and encouraging compliance. Posters and training materials are available as tools to help member companies implement the measures of the Month for Promoting Understanding. The posters feature illustrations of four pharmaceutical company employees on a white background, with the theme of the Month for Promoting Understanding prominently displayed. The "we" in the theme refers to all executives and employees of pharmaceutical association member companies, and expresses their strong determination to comply with the new standard, the revised Pharmaceutical Manufacturers Association Code. As for the training materials, it was explained that previously only "I-1 Code of Practice" had been available, but that it has been updated to reflect the recent revision, and that new training materials for "I-2 Prescription Drug Promotion Code" have also been created. Finally, he strongly urged the participants to make effective use of these posters and training materials to raise awareness of the Pharmaceutical Affairs Association (PAA) Code.

Special Lecture: "Survey Project on Marketing Information Provision Activities

Mr. Taichi Shinohara, Chief, Supervisory Guidance and Narcotics Control Division, Pharmaceutical Affairs Bureau, Ministry of Health, Labour and Welfare

Mr. Shinohara began his presentation with an overview of the background and outline of the "Survey Project on Sales Information Provision Activities of Ethical Drugs. He then gave an overview of the results of the "Survey Report on Sales Information Provision Activities in FY2024," stating that "In FY2024, a total of 18 cases of suspected advertising violations were confirmed in the provision of information on drugs," and that the most common suspected violations were "use of expressions that may misrepresent facts," followed by "explanation without evidence" and "use of other companies' products. The most common suspected violations were "use of expressions that may misrepresent facts," followed by "use of explanations without evidence" and "use of expressions that slander or defame the products of other companies," among others. The companies reported that they had submitted improvement reports after confirming the facts internally and considering future countermeasures. It was explained that, depending on the content of the guidance, follow-up may be conducted even after the report is submitted.

The following five requests were made to pharmaceutical companies and industry associations.

  1. Provide balanced information on efficacy and safety
  2. Further education for MRs
  3. Ensure thorough compliance with the Code, as inappropriate cases are more likely to occur in the highly competitive pharmaceutical industry.
  4. Provide sufficient information on drug risk management plans (RMPs).
  5. Careful explanations and sufficient prior meetings should be conducted when requesting speakers for company-sponsored seminars, etc., to avoid inappropriate sales information provision activities.

In addition, some explanations were given on Q&A (Part 4). Finally, the participants were asked to understand the "Appropriate Advertising Standards," "Guidelines for Sales Information Provision Activities," and "Surcharge System," and to continue to conduct appropriate sales information provision activities. He then concluded his presentation by answering questions that had been submitted in advance.

Acknowledgments

Mr. Yoshiyuki Ishida, Executive Director, Pharmaceutical Manufacturers Association of Japan

Yoshiyuki Ishida, Executive Director of the Pharmaceutical Manufacturers Association of Japan (PMAJ), expressed his appreciation for the participation of code management officers and code practitioners in this meeting and thanked Mr. Shinohara, the special speaker.

In relation to the first part of the meeting's theme, "Efforts for Appropriate Marketing Information Provision Activities - Appropriate Operation of Company Sponsored (Co-sponsored) Lecture Meetings," each member company asked medical professionals and others to participate in the discussion by providing information on the chairpersons and speakers (hereinafter referred to as "Speakers") of lectures sponsored or co-sponsored by pharmaceutical companies. When member companies ask medical professionals, etc. to serve as chairpersons or speakers (hereafter referred to as "role players") at lectures hosted or co-hosted by pharmaceutical companies, we explain the importance of careful explanation and sufficient communication to reduce the burden on the role players, such as by ensuring a thorough understanding at the time of the request, accepting inquiries on unclear points when preparing lecture slides, and asking for final confirmation and revision of slides with enough time to spare. We explained the importance of such careful explanations and sufficient communication, and requested the implementation of such measures.

He concluded his speech by saying, "In order to ensure a compliance system, the three elements of "organizational culture," "internal systems," and "individual skills of employees" must be in place without any deficiencies. He concluded the meeting by expressing his expectations for further promotion of compliance to code administrators and practitioners.

(Code Compliance Promotion Committee, Practice Members Keiko Yoshida and Shingo Inoue)

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