Drug Evaluation Committee Explanation of RMP Mark (Revised 2024) Toward identification of materials based on additional risk minimization activities
Pharmacovigilance Subcommittee
July 2024
In 2013, the system of the Risk Management Plan (RMP) for pharmaceuticals began, and as part of the activities to minimize the risk of pharmaceuticals under the RMP, pharmaceutical companies prepare and provide information on materials for healthcare professionals and for patients.
As the use of RMPs in the medical field has progressed, some healthcare professionals have voiced their concerns that it is difficult for them to recognize which materials are created based on RMPs. In order to make it easier for healthcare professionals to recognize "materials based on additional risk minimization activities" in the RMP, an industry standard mark (RMP mark) will be displayed on materials for healthcare professionals and patients, etc., starting in June 2017. and colors, but as an aid for the actual creation of materials, a logo set (sample) of the RMP Mark and image files (AI files) for printing were first created and published in June 2017.
In June 2024, it became possible to create RMP materials as a single entity that includes information not directly related to additional risk minimization activities, such as information that contributes to proper use (hereafter referred to as "voluntary collateralized sections "2)3). In line with this change, we have updated the "RMP Mark logo set (catalog)" and "image file for printing (AI file)" required for the description of the voluntarily secured areas. Since this is just an example, we would appreciate it if each company could use them at their own discretion according to the color, size, and other characteristics of their materials. In addition, as it may be difficult to interpret the background and contents of the notice alone, we have prepared an explanation of the setting of voluntary collateralized areas.
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As of December 2023Please [save] once to local disk and then open.
(If you "Open" directly, the ppt file may not be displayed properly.) -
As of December 2023Please download and utilize the printable data (AI file) at the bottom of the page.
Related Notices.
| Notification No. etc. | Title |
|---|---|
| (1) June 8, 2024 Office Notification | Labeling on Materials Prepared and Distributed for Additional Risk Minimization Activities in the Drug Risk Management Plan (RMP)
https://www.pmda.go.jp/safety/info-services/drugs/items-information/rmp/0002.html |
| (2) June 2024, Ministry of Health, Labour and Welfare, Pharmaceuticals Bureau, Drug Evaluation and Control Division and Drug Safety Division, jointly issued by the two divisions. | Partial Revision of Questions and Answers (Q&A) on the Drug Risk Management Plan https://www.pmda.go.jp/safety/info-services/drugs/items-information/rmp/0002.html |
| (3) June 24, 2024 Safety Committee of the Federation of Pharmaceutical Manufacturers' Associations of Japan | Revision of "Voluntary Guidelines for Labeling on Materials Prepared and Distributed for Additional Risk Minimization Activities in the Drug Risk Management Plan (RMP) |
For Healthcare Professionals (Prepared in 2018)
We have prepared the following guidance document explaining the RMP mark. Please refer to it for proper use of pharmaceutical products.
Pharmaceutical Companies (Prepared in 2018)
We have prepared a document explaining the RMP Mark, which we hope you will also use when providing information on materials with the RMP Mark to medical professionals.
RMP Mark Q&A Collection
Q&A for RMP Mark" has been prepared. Please make use of it when creating materials.
Data for printing (AI file) (updated version for 2024)
After checking the above Logo Set Catalog, please download the illustrator file (AI file) for printing below and use it when creating materials.
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As of December 2023The AI files are embedded in the PPT files 1-8 below (Illustrator CS3 version).
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As of December 2023Please save the files to your local disk and then open them. (If you "Open" directly, the ppt file may not be displayed properly.)
| RMP Mark (Blue)(22.7MB) | For white and light-colored backgrounds |
| RMP Mark (black)(22.7MB) | For white and light-colored backgrounds |
| RMP Mark (blue + white)(22.7MB) | Black on dark background |
| RMP mark (white + transparent) (22.6MB) | Black on light-colored background |
| RMP Mark (blue) small, for cards (17.4MB) | For white and light-colored backgrounds |
| 6.RMP Mark (black) small size, for cards (17.3MB) | For white and light-colored backgrounds |
| 7.RMP mark (blue + white) small, for cards (17.4MB) | Black on dark background |
| 8. RMP mark (white + transparency) small, for cards | Black on dark background |
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As of December 2023This table shows images of "Pattem2-2 (with annotations2)," "Pattem3-2 (with self-secured sections2)," and "Acronyms only" in the font (UD Shin Go-M + Helvetica (with border decoration)) as samples.
Last updated in July 2024 (First created in June 2017; updated in April 2018 and June 2024)
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Continuing Issues Response Team 1 (KT1)
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