The "2024 Meeting of Code Administration Managers and Practitioners" was held

Prior to the opening of the meeting, Ms. Chika Hirata, Chairperson of the Pharmaceutical Manufacturers Association of Japan (PMAJ) Code Compliance Promotion Committee, gave a brief introduction of the surveillance program and its objectives, followed by the following remarks

The activities of our pharmaceutical companies to create an environment in which pharmaceuticals are used appropriately through the surveillance project system will indeed serve the public interest of all citizens and patients. The proper management of this project will also enhance the trust in the system and in the various stakeholders, including the regulatory authorities, medical professionals, and pharmaceutical companies that participate in the system.

However, the surveillance project is reported once a year. We should review whether we have an environment in which we can always communicate with medical professionals as well as within the company, whether we have an environment in which we can grasp pointed out cases through communication with medical professionals, whether we have a system in which employees can easily voice their opinions, and whether we have a system in place to respond to such cases. I hope that this seminar will be a good opportunity for you to check whether your company has a system in place to respond to these questions and to review whether it is functioning properly. Since today's meeting is a hybrid of on-site and web-based participation, I hope that participants will be able to build a network with colleagues who share the same objectives.

Mr. Goh Matsumura, Chairperson of the Code Compliance Promotion Committee, explained four points, focusing on various notices and communications issued after April 2024.

(1) "Request for prevention of misdelivery of information on in-house pharmaceutical products prior to approval

The notices were issued as a reminder to the relevant departments both inside and outside the company to take necessary actions (thorough understanding, inspections, etc.) because similar cases have continued to occur even after the issuance of the notice in 2023, and the outsourcing company cannot escape liability even when the cause is the negligence of the outsourcing company.

(2) "Compliance with the Pharmaceutical Manufacturers Association Code

This notice was issued in response to the release of the report on the FY2023 Monitoring Project for Provision of Marketing Information, requesting member companies to review the report and correctly understand the Guidelines for Provision of Marketing Information, as well as to comply with the Pharmaceutical Manufacturers Association (PMA) Code.
In addition, the committee requested member companies to deepen their understanding of the Guidelines, especially with regard to the first basic concept, "2 Scope of Application," "3 Principles of Marketing Information Provision Activities," and "3 Provision of Information on Unapproved and Off-label Drugs," as well as to deepen their understanding of Q&A (Part 4) and devise ways to provide information in an appropriate manner to the medical community. (1) "Information on in-house drugs before approval

Mr. Kazuhiro Shinonaga, Practice Committee Member of the Code Compliance Promotion Committee, explained the measures for the Pharmaceutical Manufacturers Association of Japan (PMAJ) Code Understanding Promotion Month in FY 2024.

First of all, the theme for FY2024 was set as "Meeting Society's Expectations through Sincere Actions" again this year, as it was highly rated by member companies in questionnaires, etc., and the sub-theme was set as "Trust built by Code Compliance".

The poster depicts the employees of the member companies of the Pharmaceutical Manufacturers Association of Japan (PMAJ) in their various decisions and actions as they aim to earn society's trust by adhering to the "Pharmaceutical Manufacturers Association of Japan Code". The image is also expressed as "a pharmaceutical company employee with a code book in his hand and a cityscape in the background that conjures up images of society as a whole. The "Pharmaceutical Cooperation Code" can be referred to from the 2D code.

He then explained the display of the poster, inspection items, and electronic media for the poster. He also introduced a collection of examples of inspection items and the Pharmaceutical Manufacturers Association Code of Practice explanatory materials.

About the "Monitoring and Supervision of Marketing Information Provision Activities

Mr. Yasushi Ohira, Advertising Guidance Officer, Monitoring and Guidance and Narcotics Control Division, Pharmaceutical Affairs Bureau, Ministry of Health, Labour and Welfare

After explaining the background and overview of the "Surveillance Project on Sales Information Provision Activities of Ethical Drugs," Dr. Ohira gave an overview of the results of the "FY2023 Report on the Surveillance Project on Sales Information Provision Activities," saying, "Although the overall picture cannot be estimated from this project, even though new-type coronavirus infection was moved to Class 5 infection and sales information provision activities became more active, there was no significant increase in inappropriate cases. However, the number of inappropriate cases did not increase significantly even after the new coronavirus infection became a category 5 infectious disease and sales information provision activities became active. On the other hand, the number of general reports has increased for three consecutive years, partly due to increased awareness. We will continue to monitor the changes that will occur as a result of the new style of sales information provision that combines face-to-face and online activities," he said.

He then explained the main points of the cases of questionable reporting, which were "explanations without evidence," "emphasis on efficacy only," and "slandering or defaming other companies' products.

Yoshiyuki Ishida, Executive Director of the Pharmaceutical Manufacturers Association of Japan (PMAJ), expressed his appreciation for the participation in the meeting by code administration managers and code practitioners, and thanked Mr. Ohira, the special lecturer speaker, for his presentation.

Although the number of guidance cases in this surveillance project report has decreased considerably, I have heard that the awareness of the guidelines among medical professionals is about 30%. We are concerned about whether we are truly identifying cases that are considered inappropriate. As for general reporting, the number of reports from highly sensitive medical professionals is increasing and the environment is becoming more conducive. To this end, companies need to train their medical representatives to speak scientifically, but this is not limited to that. I hope that code administrators and code practitioners will be the starting point of this trend.