Meeting of Code Administration Managers and Practitioners for 2025

The JPMA Code Compliance 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 persons participated in the meeting, mainly code management managers and code practice managers from 69 member companies. A summary of the meeting is reported below.

The venue  

Program of the "2025 Meeting of Code Administration Managers and Practitioners

Moderator: Mr. Toshiyuki Yamano, JPMA Code Compliance Committee, Practice Committee Member

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, JPMA Code Compliance Committee

  2. Case Studies of Code Violation Actions

    Hiroaki Mizoguchi, Practice Committee Member

  3. Revision of the JPMA Code

    Masato Wakai Chairperson

  4. Measures for the JPMA Code Understanding Promotion Month

    Hyoue Kawai, Practice Committee Member

  5. Special Lecture: "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. Acknowledgements

    Mr. Yoshiyuki Ishida, Executive Director, JPMA

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, JPMA Code Compliance Committee

Ms. Kaoru Ouchi, Chairperson of the JPMA Code Compliance Committee, made the following remarks in her first speech: "I believe that all of you here are the key players in maintaining and promoting compliance systems at your respective companies. I know that you see compliance as an obligation, but I believe that you can achieve greater results by promoting it in a rewarding manner," 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, JPMA Code Compliance Committee, Practice Member)

Mr. Hiroaki Mizoguchi, JPMA Code Compliance Committee member, explained the following points

  1. JPMA's Approach to Measures

    In the "JPMA Code of Practice: Rules on Measures against Violations," the term "measures" is defined as a request by the Code Compliance Committee to the violating company to voluntarily make improvements. In other words, the JPMA does not impose sanctions on a company that violates the Code, but focuses on the company's efforts toward improvement. 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 JPMA Code

Masato Wakai, Chairperson, JPMA Code Compliance Committee

Mr. Masato Wakai, Chairperson of the JPMA Code Compliance Committee, explained about the JPMA Code of Practice, which was revised in May 2025.

  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 Pharmaceuticals Association's Code of Practice

    The JPMA Code, which will be revised in May 2025 and come into effect in October, is to be reflected in each JPMA company's own code, and we requested that all member companies make sure that they are well informed of the revised JPMA Code. We also asked member companies to cooperate in a questionnaire conducted by the Code Compliance Promotion Committee to understand the status of compliance with the revised Pharmaceutical Manufacturers Association of Japan (PMAJ) Code and any questions they may have.

Measures for the Code Understanding Promotion Month

JPMA Code Compliance Committee: Hyoe Kawai, Practice Committee Member

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

He explained that the theme for 2025 was set as "Code Revision 2025! - Our New Standard" with the aim of spreading the JPMA Code, which was revised for the first time in six years, to all member companies and encouraging compliance with it. 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 JPMA member companies, expressing their strong determination to comply with the new standard, the revised JPMA 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 JPMA codes.

Special lecture: "Survey Project on Sales 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. Company-sponsored seminars, etc., should be carefully explained and thoroughly discussed in advance when requesting speakers to avoid inappropriate sales information provision activities.

In addition, some Explanations were given on the 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.

Acknowledgements

Mr. Yoshiyuki Ishida, Executive Director, JPMA

Mr. Yoshiyuki Ishida, JPMA's Executive Director, expressed his appreciation for the participation of code administration managers and code practitioners in the meeting, and thanked Mr. Shinohara, the special speaker, for his presentation.

In relation to the first part of the seminar, "Efforts for Appropriate Provision of Marketing Information - Appropriate Operation of Company Sponsored (Co-sponsored) Lecture Meetings", we would like to request each member company to ask medical professionals to chair or speak at a lecture meeting sponsored or co-sponsored by a pharmaceutical company in order to reduce the burden on the role players. 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 that they are aware of the importance of the lecture when requesting a lecture, accepting inquiries about unclear points when preparing slides, and requesting 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 Committee, Keiko Yoshida and Shingo Inoue, Practice Members)

Back to 2025

Share this page

TOP

Site Search