Information Publications
| Title | Guide to the Preparation of "Drug Information Sheet for Ethical Drugs -Corresponding to the guideline in 2009 -August, 2020 |
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| Edited by | Drug Evaluation Committee, Pharmacovigilance Subcommittee | |
| Month of issue | August 2020 | |
| Size Page | A4 size, 218 pages | |
| Code | BB2001 | |
| Price | Members 3,800 yen + tax, General 5,800 yen + tax | |
| Contents | This time, "Guidelines for the Description of the Package insert of Ethical Drugs" (Notification of the Director-General of the Pharmaceuticals and Life Sanitation Bureau, Ministry of Health, Labour and Welfare No. 0608-1 dated June 8, 2009) and "Points to Consider in the Description of the Package insert of Ethical Drugs" (Notification of the Director of the Safety Measures Division, Pharmaceuticals and Life Sanitation Bureau, Ministry of Health, Labour and Welfare No. 0608-1 dated June 8, 2009) were published in the "Pharmaceutical Affairs Bureau of the Ministry of Health, Labour and Welfare". (Notification of the Director-General of the Safety Measures Division, Pharmaceutical and Life Sanitation Bureau, Ministry of Health, Labour and Welfare, dated June 8, 2017), "Guidelines for the Description in the Appendix of Vaccines" (Notification of the Director-General of the Pharmaceutical and Life Sanitation Bureau, Ministry of Health, Labour and Welfare, dated December 27, 2017, Pharmaceutical Affairs Bureau, No. 1227-7) and "Guidelines for the Description in the Appendix of Vaccines" (Notification of the Director-General of the Pharmaceutical and Life Sanitation Bureau, Ministry of Health, Labour and Welfare, dated December 27, 2017, Pharmaceutical Affairs Bureau, No. 1227-11) (collectively, the "Guidelines"). In accordance with the "Guidelines for the Preparation of Attached Documents for Ethical Drugs" (the "Guidelines for the Preparation of Attached Documents for Ethical Drugs"), the Ministry of Health, Labour and Welfare (MHLW) has decided to publish the "Guide to the Preparation of Attached Documents for Ethical Drugs: Compliance with the Guidelines for the Preparation of Attached Documents for Ethical Drugs - August 2020. In addition to the aforementioned notifications, this document contains examples of descriptions corresponding to several Q&A issued by the Pharmaceuticals and Medical Devices Bureau of the Ministry of Health, Labour and Welfare, the Pharmaceuticals and Medical Devices Agency, and the Safety Committee of the Federation of Pharmaceutical Manufacturers' Associations of Japan (FPMAJ), as well as a "Commentary" with points to keep in mind in each section. The attached document is the "Explanation" for the Guidelines for the Registration of Pharmaceuticals and Medical Devices. We hope you will find it useful in preparing the attached document in compliance with the Guideline for the Description of Pharmaceutical Drugs in 2009. |
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| Booklet Contents | Chapter 1 | Attachments under the Pharmaceuticals and Medical Devices Act |
| Chapter 2 | Guidance for Preparation of Attached Documents for the New Description Guideline | |
| Chapter 3 | Guidance for Preparation of Attachment Documents for Biologically Derived Products | |
| Chapter 4 | Procedures for Revising Attachments | |
| Chapter 5 | Procedures for Transferring Attachment Information at the Time of Marketing Authorization Succession | |
| Chapter 6 | Interlocking with Other Materials when Adapting to New Guidelines for Attached Documents | |
| Appendix CD | PDF file of this document | |
| Sales | Japan Pharmaceutical Information Center (JAPIC) Please apply for the book from the "Pharmaceutical Cooperative Association Book Purchase Application". Please apply for it from the following link. |
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