Notifications issued by the MHLW related to safety measures for drugs are listed here.
| Date | Title |
|---|---|
| FY2022 | |
| February 17, 2023 PSEHB Notification No. 0217-1 |
Amendment of the Instructions for Electronic Package Inserts Regarding Results of Studies Using Medical Information English-translated notification [107 KB] Original notification in Japanese [109 KB] |
| February 17, 2023 PSEHB/PSD Notification No.0217-1 |
Points to Consider for Describing the Results of Studies Using Medical Information Database in Electronic Package Inserts English-translated notification [97.1 KB] Original notification in Japanese [104 KB] |
| February 17, 2023 PMDA/CSO No.60 |
Points to Consider, etc. for Consultation Associated With Revision, etc. of Package Inserts, etc. |
| September 13, 2022 HPB/DPMM 0913 No.1 PSEHB/PSD 0913 No.1 |
Labeling of Codes on Containers to Identify Prescription Drugs English-translated notification [234 KB] Original notification in Japanese [247 KB] |
| May 31, 2022 Administrative Notice |
Questions and Answers (Qs and As) on Early Post-marketing Phase Vigilance for Prescription Drugs English-translated administrative notice [146 KB] Original administrative notice in Japanese [268 KB] |
| May 31, 2022 PSEHB/SD 0531 No.1 |
Implementation Method, etc. of Early Post-marketing Phase Vigilance for Prescription Drugs English-translated notification [44.3 KB] Original notification in Japanese [142 KB] |
| FY2021 | |
| October 8, 2021 PSEHB/PED1008 No.1 PSEHB/PSD1008 No.1 PSEHB/CND1008 No.1 |
Self-inspection on Risks of Contamination with Nitrosamines in Drugs English-translated notification [67.2 KB] Original notification in Japanese [160 KB] |
| September 27, 2021 Administrative Notice |
Notice concerning "Standard Workflow for Consideration of Safety Measures such as Revision of Electronic Drug Product Package Inserts" English-translated administrative notice [110 KB] Original administrative notice in Japanese [282 KB] Reference material: Standard Workflow for Consideration of Safety Measures English-translated reference material [230 KB] Original reference material in Japanese [130 KB] |
| FY2020 | |
| February 19, 2021 Administrative Notice June 11, 2021 (1st Amendment) July 14, 2021 (2nd Amendment） |
Questions and Answers (Qs and As) regarding “Provision of Information on Precautions for Drugs, etc.” English-translated administrative notice [19.2 KB] Attachment: English-translated attachment [114 KB] Original administrative notice in Japanese (February 19, 2021) [543 KB] 1st amendment in Japanese (June 11, 2021) [26.0 KB] 2nd amendment in Japanese (July 14, 2021) [279 KB] The original Japanese version was established on February 19 and revised on June 11 and July 14, 2021. The English version includes these corrections. |
| February 19, 2021 PSEHB/PSD 0219 No.1 |
Provision of Information on Precautions, etc. for Drugs, etc. English-translated notification [129 KB] Original notification in Japanese [139 KB] |
| February 14, 2021 PSEHB/PED 0214 No.1 PSEHB/PSD 0214 No.1 |
Considerations for Use of the Coronavirus Modified Uridine RNA Vaccine (SARS-CoV-2) (Comirnaty intramuscular injection) English-translated notification [122 KB] Original notification in Japanese [156 KB] Administrative notice of partial correction in Japanese (February 16, 2021) [163 KB] The English version includes corrections made by the administrative notice of partial correction issued on February 16, 2021. |
| September 1, 2020 Administrative Notice |
Results of the Health Effect Assessment of the Use of Ranitidine Hydrochloride Products or Nizatidine Products in Which N-dimethylnitrosamine Was Detected English-translated administrative notice [199 KB] Original administrative notice in Japanese [328 KB] Reference material: Risk assessment of the use of ranitidine products and nizatidine products in which carcinogenic substance N-nitrosodimethylamine was detected English-translated reference material [305 KB] |
| May 7, 2020 PSEHB/PED 0507 No.12 PSEHB/PSD 0507 No.1 |
Points to Consider for Use of Remdesivir English-translated notification [45.7 KB] Original notification in Japanese [132KB] |
| FY2018 | |
| May 29, 2018 HPB/GAD/MSPO 0529 No.1 PSEHB/PSD0529 No.1 |
Guidance on Appropriate Medication for Elderly Patients (general) English-translated notification [1,354 KB] Original notification in Japanese [1,503 KB] |