Held the "FY2024 Workshop for Persons Responsible for Product Information Outline Management and Practice Managers
On March 25, 2025, the "FY2024 Workshop for Persons Responsible for Product Information Overview Management and Practical Responsible Persons" was held. Approximately 550 people participated on the day, mainly those in charge of product information overview management and practical affairs at member companies, as well as those in charge of material review at their companies. Below is a report on the outline of this training session.
The venue
Program
| Moderator | Tomohiro Inoue, Member, Product Information Outline Review Committee, Pharmaceutical Manufacturers Association of Japan (PMAJ) |
|---|---|
| (1) Opening remarks | (6) Chairperson of the Pharmaceutical Manufacturers Association of Japan (PMAJ) Product Information Outline Review Committee |
| (2) Advertisement regulations and preparation guidelines | Masahiko Kimura, Member, Product Information Outline Review Committee, Japan Pharmaceutical Manufacturers Association (JPMA) |
| (3) Questions about the preparation guidelines | Yoichiro Kon Member, Product Information Outline Review Committee, Pharmaceutical Association of Japan
Tamiyo Yokoyama Member Kenichiro Sannomiya, Member |
| (4) Special lecture "How information should be provided from the viewpoint of medical professionals | Special Lecture Moderator: Kanae Ogiwara, Member, Product Information Outline Review Committee, Pharmaceutical Society of Japan
Speaker: Dr. Hideo Nakata, Drug Information Officer, Keio University Hospital |
| (5) Closing remarks | Mr. Yoshiyuki Ishida, Executive Director, Pharmaceutical Manufacturers Association of Japan |
(1) Opening remarks
(6) Chairperson of the Pharmaceutical Manufacturers Association of Japan (PMAJ) Product Information Outline Review Committee
At the outset, he expressed his gratitude to the member companies for their thorough compliance with the Guidelines for the Preparation of Product Information Summaries for Ethical Drugs (hereinafter referred to as "the Guidelines").
He concluded with a discussion on the importance of the topics covered in this workshop, and the importance of understanding the changes in surveillance projects, etc., and of taking a positive attitude toward those changes in order to provide accurate and appropriate drug information to medical professionals.
(2) Advertisement regulations and preparation guidelines
Masahiko Kimura, Member, Product Information Outline Review Committee, Japan Pharmaceutical Manufacturers Association (JPMA)
In the background of the guidelines, there are laws and regulations such as the Pharmaceutical Affairs Law, the Standards for Proper Advertisement of Drugs, the Guidelines for Activities to Provide Marketing Information, and the Pharmaceutical Manufacturers Association of Japan Code of Practice as voluntary standards of the Pharmaceutical Manufacturers Association of Japan (PMAJ). The importance of fully understanding these regulations and voluntary standards, as well as the guidelines, when preparing materials was explained. He also reminded the audience to take advantage of the e-learning 2023 version of the guidelines for understanding the guidelines.
Promotional materials and advertisements are under increasing scrutiny, and the review by the Pharmaceutical Manufacturers Association of Japan (PMAJ) is limited to "product information summaries" and "advertisements" created within three months after marketing approval. Therefore, it is most important for each member company to understand these laws, regulations, voluntary standards, and preparation procedures, and to conduct thorough internal reviews.
Finally, he requested that those responsible for managing the overview of ethical drug product information and those in charge of practical operations understand their respective responsibilities and continue to properly prepare promotional materials for their respective companies.
(3) Questions about the preparation guidelines
Efficacy (Statistics)
Yoichiro Kon, Member, Product Information Outline Review Committee, Pharmaceutical Manufacturers Association of Japan
In this session, we introduced our views on the following topics, which were asked by member companies, when the Pharmaceutical Manufacturers Association of Japan (PMAJ) Review Committee examines them.
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Nominal p-value
- Expression of nominal p-value as a basis
- The nominal p-value is a rule for clinical results.
- The "p-value of the analysis considering type 1 error" included in the validation framework -
Test Procedure
- Necessity of stating the end of the verification procedure
- Introduction of specific examples
Efficacy (Other)
Tamiyo Yokoyama, Member, Product Information Outline Review Committee, Japan Pharmaceutical Manufacturers Association (JPMA)
In this session, we introduced our views on the following topics, which were asked by member companies, when the Pharmaceutical Manufacturers Association of Japan (PMAJ) Review Committee examines them.
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Subgroup Analysis
- Regarding the description of "was consistent"
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Reference Information
- Regarding the concept of "clear and generalized definitions of evaluation indices and scores
- Handling of reference information for sub-scales of daily activities and QOL -
Limitation
- Regarding the tests subject to the description of "Limitation
- Background of "prominently displayed" in the Limitation
Safety
The Pharmaceutical Manufacturers Association of Japan (PMAJ) Product Information Outline Review Committee
In this session, we introduced our views on the following topics, which were asked by member companies, when the Pharmaceutical Manufacturers Association of Japan (PMAJ) Review Committee examines them.
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Safety
- Examples of expressions that "emphasize and assure safety
- In a clinical comparison study with a double-blind phase and a continuation phase (extension phase), the study design for switching to the drug in question should be described only in the continuation phase (extension phase).
Examples of describing safety results when only the continuation phase (extension phase) is introduced
- Example of the description in the table only
- Examples of "person-years" description
- Examples of descriptions of adverse reactions (or adverse events) when there are many event names
(4) Special Lecture
How information should be provided from the viewpoint of medical professionals
Hideo Nakata, Drug Information Officer, Keio University Hospital
In his speech, he discussed the changes in pharmacist work, the current status of "Drug Information Office" work, and the importance of information provided by pharmaceutical companies as follows.
- Regarding changes in pharmacist work, all pharmacists, not just those in charge of the Drug Information Office, are now required to respond to drug information, and ward pharmacists are also actively consulting and providing information on drugs.
- In the meantime, the role of the Drug Information Office is shifting to the ward pharmacists as the main provider of drug information in the hospital wards, and the Drug Information Office, as the hospital's information center, is responsible for collecting, evaluating, and managing a wide range of drug information and issuing information in cooperation with the ward pharmacists. It should also be expected to provide more specialized consultation services.
- The request to pharmaceutical companies is that they also utilize review reports in the field because of the need to provide information on changes in dosage form and because the information in the package inserts is sometimes limited and insufficient.
Lastly, the purpose of handling drug information is not to "handle itself," but to use it to "contribute to the improvement of the quality and efficiency of medical care," and that it is a means to "lead to operations that are conscious of outcomes for patients. He concluded that it is important to provide "necessary and sufficient information" for proper use of the product and especially information on what kind of person needs what kind of caution.
(5) Closing remarks
Mr. Yoshiyuki Ishida, Executive Director, Pharmaceutical Manufacturers Association of Japan
It is important for pharmaceutical companies to correctly convey drug information to healthcare professionals so that they can use drugs appropriately. The first half of today's workshop focused on how to create (promotional materials) and the second half on how to deliver (drug information). He asked for the continued understanding and cooperation of each member company and concluded the meeting by saying that everyone involved in drug information should think about the creation and delivery of drug information as a set and work to see whether the drug information along with promotional materials are really being delivered correctly to medical professionals and whether they are being used appropriately by medical professionals. He concluded the meeting by asking for the continued understanding and cooperation of member companies.
(Hiroe Takeuchi and Emi Kan, Product Information Outline Review Committee)