Workshop for Persons Responsible for Product Information Overview Management and Practical Responsibility for Product Information Overview Management in 2025" was held.

(6) Chairperson, JPMA Review Board of Ethical Drug Product Information Brochure Mitsuhiro Kondo

The members expressed their gratitude for their cooperation in complying with the Guidelines for the Preparation of Product Information Summaries for Ethical Drugs (hereinafter referred to as "the Guidelines").

In this workshop, a special lecture will be given on "Current Status and Future of Regulations on Advertisements of Drugs", and in the latter half of the workshop, the JPMA Board will introduce some specific examples of such regulations. In his opening remarks, Mr. Kato said that he hoped that the workshop would be meaningful for each company to take back the contents of the workshop to improve the quality of their daily Review Board of Ethical Drug Product Information Brochure and other review work.

Mr. Daisaku Sato, Deputy Director-General (Pharmaceuticals), Minister's Secretariat, Ministry of Health, Labour and Welfare

In his speech, he emphasized the importance of compliance with advertising regulations such as the Act on Quality, Efficacy and Safety Assurance of Pharmaceuticals and Medical Devices and the Guidelines for Marketing Information Provision Activities of Ethical Drugs, as the provision of information by pharmaceutical companies plays an important role directly related to the quality of healthcare and patient outcomes.

Using specific examples of questionable reports from the FY2024 "Investigation Project on Sales Information Provision Activities of Ethical Drugs," he explained the risks posed by inappropriate expressions and biased presentation of evidence, such as "using expressions that may misrepresent facts" and "providing explanations without evidence," and stated, "Recently, the number of obvious He added, "Recently, the number of obvious violations has been decreasing, but the number of difficult-to-judgment violations has been increasing," and that "even other companies' cases should be taken as a lesson from others.

Maki Nakamura, Member, Review Board of Ethical Drug Product Information Brochure, JPMA

He also introduced the results of a questionnaire survey conducted by JPMA member companies to visualize the current status of their organizations and review systems related to material review, as well as the roles of the person in charge of product information overview management and the person in charge of practical affairs.

Mr. Yoshiyuki Ishida, Executive Director, JPMA

As the date of this workshop was the 15th anniversary of the Great East Japan Earthquake, the importance of accurate information dissemination in unexpected situations was mentioned again, looking back on that time.

In terms of information dissemination, he expressed his gratitude for the fact that no serious problems have arisen in recent years in the provision of information by MRs, which he attributed to the daily efforts of member companies to prepare appropriate materials and provide information.

On the other hand, he also mentioned that not everything is perfect and that there are still some issues related to material preparation, and that while it is important for participants to understand and take home with them the technical points introduced in today's workshop, sometimes it is also important to consider whether the intention of the material may cause unexpected discomfort to others and to imagine how others may receive it. The workshop was concluded by expressing the expectation that the person in charge of product information management/practice should exercise leadership in this issue to the department that prepares the materials.