The following notifications and administrative notices issued by the Ministry of Health, Labor and Welfare (MHLW) or the PMDA were selected for translation among those related to safety measures for drugs in consideration of priority for translation.
| Date/ Notification No. |
Title |
|---|---|
| August 10, 2023 Administrative Notice |
Questions and Answers (Qs & As) on the Guidance for Provision of Dear Healthcare Professional Letters of Emergent/Rapid Safety Communications English-translated administrative notice [66.9 KB] Original administrative notice in Japanese [87.32 KB] |
| Date/ Notification No. |
Title |
|---|---|
| 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. English-translated notification [252 KB] Original notification in Japanese [1,024 KB] |
| 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] |
| Date/ Notification No. |
Title |
|---|---|
| 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] |
| Date/ Notification No. |
Title |
|---|---|
| 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] |
| Date/ Notification No. |
Title |
|---|---|
| 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] |
| Date/ Notification No. |
Title |
|---|---|
| September 29, 2014 PFSB/SD Notification No. 0929-2 |
Guideline on Revision of Precautions and other information English-translated notification [95KB] Original notification in Japanese [242KB] |
| Date/ Notification No. |
Title |
|---|---|
| December 2, 2013 PFSB/SD Notification No.1202-1 |
Good Vigilance Practice Ordinance to be complied by Marketing Authorization Holders English-translated notification [64KB] Original notification in Japanese [145KB] |