Notifications issued by the MHLW related to safety measures for drugs are listed here.
| Date | Title | Original in Japanese |
|---|---|---|
| PMDA/CSO No.60 February 17, 2023 |
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 | |
| July 29, 2022 PMDA/OIMS Notification No.0729001 PMDA/OPI Notification No.0729001 PMDA/OPII Notification No.0729001 PMDA/OMQVMD Notification No.0729001 |
Points to Consider, etc. for Consultation associated with Revision, etc. of Package Inserts, etc. Note) Abolished on February 17, 2023. |
|
| May 31, 2022 Administrative Notice |
Questions and Answers (Qs and As) on Early Post-marketing Phase Vigilance for Prescription Drugs | |
| May 31, 2022 PSEHB/SD 0531 No.1 |
Implementation Method, etc. of Early Post-marketing Phase Vigilance for Prescription Drugs | |
| December 28, 2021 PSEHB/PED1228 No.1 PSEHB/PSD1228 No.1 |
Handling of Prescription Drugs, Guidance-Mandatory Drugs, OTC drugs, Quasi-drugs, and Cosmetics Containing Methylrozaniline Chloride | |
| 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 | |
| September 27, 2021 Administrative Notice |
Notice concerning "Standard Workflow for Consideration of Safety Measures such as Revision of Electronic Drug Product Package Inserts" Reference:Standard Workflow for Consideration of Safety Measures |
|
| September 6, 2021 PSEHB/PED0906 No.6 PSEHB/PSD0906 No.20 PSEHB/BBPD0906 No.1 |
Points to Consider for the use of Freeze-dried Human Fibrinogen for Acquired Afibrinogenemia which Has Newly Completed a Prior Evaluation for a Public Knowledge-based Application by the Pharmaceutical Affairs and Food Sanitation Council | |
| September 6, 2021 PSEHB/PED0906 No.2 PSEHB/PSD0906 No.16 |
Off-label Use of a Drug which Has Newly Completed a Prior Evaluation for a Public Knowledge-based Application by the Pharmaceutical Affairs and Food Sanitation Council | |
| July 26, 2021 PSEHB/PED0726 No.1 PSEHB/PSD0726 No.1 |
Addendum for Considerations for Use of the Coronavirus Modified Uridine RNA Vaccine (SARS-CoV-2) (COVID-19 Vaccine Moderna Intramuscular Injection) | |
| June 16, 2021 PSEHB/PED0616 No.13 PSEHB/PSD0616 No.1 |
Partial Revision of Precautions Included in Package Inserts, etc. for Cold Medicines, etc. Appendix: Precautions Included in Package Inserts, etc. for Cold Medicines, etc. |
|
| June 2, 2021 PSEHB/PED0602 No.3 PSEHB/PSD0602 No.1 |
Addendum for Considerations for Use of the Coronavirus Modified Uridine RNA Vaccine (SARS-CoV-2) (Comirnaty Intramuscular Injection) | |
| May 21, 2021 PSEHB/PED0521 No.9 PSEHB/PSD0521 No.9 |
Considerations for Use of the Coronavirus Vaccine(SARS-CoV-2) (recombinant chimpanzee adenovirus vector) (Vaxzevria Intramuscular Injection) | |
| May 21, 2021 PSEHB/PED0521 No.5 PSEHB/PSD0521 No.5 |
Considerations for Use of the Coronavirus Modified Uridine RNA Vaccine (SARS-CoV-2) (COVID-19 Vaccine Moderna Intramuscular Injection) *Addenndum Issued on July 26, 2021 |
|
| May 13, 2021 PSEHB/PED0513 No.1 PSEHB/PSD0513 No.2 |
Partial Revision of Precautions Included in Package Inserts, etc. for OTC Traditional Kampo Products Appendix: Partial Revision of Precautions Included in Package Inserts, etc. for OTC Traditional Kampo Products |
|
| March 31, 2021 HPB/GAD/MSPO0331 No.1 PSEHB/PSD0331 No.1 |
How to Start and Proceed with Improving Polypharmacy among the Elderly in Hospitals Appendix: How to Start and Proceed with Improving Polypharmacy among the Elderly in Hospitals Reference 1: Guidance concerning Appropriate Use of Medication by Elderly Patients (general) Reference 2: Guidance of Appropriate Medication for Elderly Patients [particular (by recuperation environment)] |
|
| 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.” Attachment : 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. | |
| February 16, 2021 Administrative Notice |
Partial Correction of Considerations for Use of the Coronavirus Modified Uridine RNA Vaccine (SARSCoV-2) (Comirnaty intramuscular injection) | |
| February 14, 2021 PSEHB/PED 0214 No.1 PSEHB/PSD 0214 No.1 |
Considerations for Use of the Coronavirus Modified Uridine RNA Vaccine (SARSCoV-2) (Comirnaty intramuscular injection) *The English version includes corrections made by the Administrative Notice of Partial Correction Issued on February 16 2021. |
|
| December 25, 2020 PSEHB/PED 1225 No.9 PSEHB/PSD 1225 No.1 |
Points for Consideration concerning the Partial Change Approval on Recombinant Adsorbed Quadrivalent Human Papillomavirus-like Particle Vaccine (yeast origin) (GARDASIL® Aqueous Suspension for Intramuscular Injection Syringes) for Prevention of Human Papillomavirus Infection | |
| October 29, 2020 PSEHB/GAD1029 No.1 PSEHB/PED1029 No.1 PSEHB/PSD1029 No.1 PSEHB/CND1029 No.1 |
Points for Consideration concerning the Use of Oxycodone Hydrochloride Extended Release Tablets Appendix: Overall Diagram of the Management System Using the Checkｌist |
|
| October 19, 2020 Administrative Notice |
Results of the Health Effect Assessment of the Use of Metformin Products in which N-nitrosodimethylamine Was Detected | |
| September 25, 2020 PSEHB/PED 0925 No.8 |
Points for Consideration concerning the Use of Ravulizumab (genetical recombination) | |
| September 25, 2020 PSEHB/PED 0925 No.3 PSEHB/PSD 0925 No.2 |
Points for Consideration concerning the Use of Paliperidone Palmitate Aqueous Suspension for IM Injection (Intramuscular Injection for 12-week Interval Administration) | |
| September 4, 2020 Administrative Notice |
Revision of Vaccination Intervals for Different Vaccines (Request for Circulation) Appendix: Notice of Revision of the Package Insert for Vaccine Products |
|
| 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 Reference material : Risk assessment of the use of ranitidine products and nizatidine products in which carcinogenic substance N-nitrosodimethylamine was detected |
|
| August 17, 2020 PSEHB/PED 0817 No.1 PSEHB/PSD 0817 No.1 |
Points for Consideration concerning the Use of Osimertinib Mesilate | |
| July 30, 2020 PSEHB/GAD0730 No.1 PSEHB/PED0730 No.9 PSEHB/PSD0730 No.1 PSEHB/CND0730 No.10 |
Extension of the Period for Transitional Measures on Modafinil (Modiodal® Tablet 100mg) due to the Covid-19 | |
| July 21, 2020 PSEHB/PED 0721 No.1 PSEHB/PSD 0721 No.1 |
Points for Consideration concerning the Administration of Recombinant Adsorbed 9-valent Human Papillomavirus-like Particle Vaccine (yeast origin) (SILGARD® Aqueous Suspension for Intramuscular Injection Syringes) for Prevention of Human Papillomavirus Infection | |
| May 27, 2020 PSEHB/GAD0527 No.1 PSEHB/PED0527 No.5 PSEHB/PSD0527 No.1 PSEHB/CND0527 No.1 |
Extension of the Period for Transitional Measures on Methylphenidate Hydrochloride Preparations (Concerta Tablets 18 mg, 27 mg, 36 mg) due to the Covid-19 | |
| May 7, 2020 PSEHB/PED 0507 No.12 PSEHB/PSD 0507 No.1 |
Points for Consideration concerning the Use of Remdesivir | |
| March 25, 2020 PSEHB/PED 0325 No.1 PSEHB/PSD 0325 No.1 |
Points for Consideration concerning the Use of Trastuzumab Deruxtecan (genetical recombination) | |
| February 28, 2020 PSEHB/PSD 0228 No.5 |
Revisions of Precautions in Package Inserts concerning the Dosing Intervals between Different Vaccines doses *Related Administrative Notice Issued on September 4, 2020 |
|
| February 25, 2020 HSB/HSD 0225 No.3 PSEHB/PSD 0225 No.8 PSEHB/CND 0225 No.5 |
Resolution of the Delayed Supply of Haemophilus influenzae type b Conjugate Vaccine (conjugate to tetanus toxoide) (branded name ActHIB) | |
| February 21, 2020 PSEHB/GAD0221 No.1 PSEHB/PED0221 No.5 PSEHB/PSD0221 No.1 PSEHB/CND0221 No.1 |
Points for Consideration concerning the Use of Modafinil (MODIODAL Tablets 100mg) Appendix: Summary of the Guidance of Appropriate Medication for MODIODAL Tablets *Related Notification Issued on July 30, 2020 |
|
| January 27, 2020 HSB/HSD 0127 No.2 PSEHB/PSD 0127 No.2 PSEHB/CND 0127 No.4 |
Measures concerning the Temporarily Delayed Supply of Haemophilus influenzae type b Conjugate Vaccine (Conjugate to Tetanus Toxoid) (branded name: ActHIB) *Related Notification Issued on Februaly 25, 2020 |
|
| December 26, 2019 Administrative Notice |
Handling of Solvent Containers Bundled with Haemophilus influenzae type b Conjugate Vaccine (Conjugate to Tetanus Toxoid) (branded name: ActHIB) (points to be considered) | |
| December 9, 2019 Administrative Notice |
Measures for the Detection of Carcinogenic Substances from Metformin Hydrochloride | |
| December 6, 2019 PSEHB/PED1206 No.5 |
Points to be Considered concerning the Use of Panobinostat Lactate Preparations | |
| December 6, 2019 PSEHB/PED1206 No.1 PSEHB/PSD1206 No.1 |
Points to be Considered concerning the Use of Crizotinib Preparations | |
| November 21, 2019 Administrative Notice |
Issuance of Briefing Material for Package Inserts of Generic Prescription Drugs (information provision) | |
| November 21, 2019 PSEHB/PSD1121 No.2 |
Efforts to Raise Awareness of Precautions regarding Anti-Influenza Drugs | |
| September 17, 2019 Administrative Notice |
Measures for the Detection of Carcinogenic Substances from Ranitidine Hydrochloride | |
| September 4, 2019 PSEHB/GAD0904 No.1 PSEHB/PED0904 No.3 PSEHB/PSD0904 No.1 PSEHB/CND0904 No.1 |
Points for Consideration concerning the Use of Methylphenidate Hydrochloride Preparations (Concerta Tablets 18 mg, 27 mg, 36 mg) Appendix: Outline of Logistic Management Implemented by Marketing Authorization Holder |
|
| July 30, 2019 PSEHB/PED0730 No.5 PSEHB/PSD0730 No.5 |
Points for Consideration concerning the Use of Erlotinib Hydrochloride Preparations Indicated for Non-small Cell Lung Cancer (NSCLC) and Unresectable Pancreatic Cancer | |
| July 30, 2019 PSEHB/PED0730 No.1 PSEHB/PSD0730 No.4 |
Points for Consideration concerning the Use of Everlorimus Preparations Indicated for Renal Cell Carcinoma and Neuroendocrine Tumour | |
| July 9, 2019 PSEHB/PSD0709 No.11 PSEHB/PSD0709 No.12 |
Dissemination of Information concerning the Revisions of Precautions for Medicines Containing Codeine Phosphate Hydrate, Dihydrocodeine Phosphate, or Tramadol Hydrochloride (request) | |
| July 9, 2019 PSEHB/PED0709 No.9 PSEHB/PSD0709 No.13 |
Partial Revision of Precautions Included in Package Inserts, etc. of Cold Medicines, etc. Appendix: Precautions included in Package Inserts, etc. for Cold Medicines, etc. |
|
| July 9, 2019 PSEHB/PED0709 No.5 PSEHB/PSD0709 No.1 |
Points for Consideration concerning the Use of Erlotinib Hydrochloride Preparations Indicated for Non-small Cell Lung Cancer (NSCLC) and Unresectable Pancreatic Cancer *Abolished on July 30, 2019 |
|
| July 9, 2019 PSEHB/PED0709 No.1 PSEHB/PSD0709 No.2 |
Points for Consideration concerning the Use of Everlorimus Preparations Indicated for Renal Cell Carcinoma and Neuroendocrine Tumour *Abolished on July 30, 2019 |
|
| Jun 18, 2019 PSEHB/PED0618 No.9 |
Points for Consideration concerning the Use of Ravulizumab (genetical recombination) Preparations | |
| June 18, 2019 PSEHB/PSD0618 No.2 |
Revisions of Precautions in Package Inserts concerning "glaucoma" etc. as a contraindication for anticholinergic drugs | |
| June 14, 2019 HPB/GAD/MSPO0614 No.1 PSEHB/PSD0614 No.1 |
Guidance of Appropriate Medication for Elderly Patients [particular (by recuperation environment)] | |
| May 30, 2019 PSEHB/PED0530 No.11 PSEHB/PSD0530 No.2 |
Partial Revision of Precautions included in Package Inserts, etc. for Cold Medicines, etc. | |
| March 26, 2019 PSEHB/GAD0326 No.1 PSEHB/PED0326 No.1 PSEHB/PSD0326 No.8 PSEHB/CND0326 No.50 |
Points for Consideration concerning the Use of Lisdexamfetamine Mesilate Preparations Appendix: Outline of Proper Logistic Management of Vyvanse Capsules |
|
| March 26, 2019 PSEHB/PSD0326 No.1 |
Direct Patient Reporting of Adverse Drug Reactions Appendix: Plan and Procedures for Implementation (Attachment) Reporting Form |
|
| March 15, 2019 Administrative Notice |
Issuance of Briefing Material for Instructions for Package Inserts of Prescription Drugs (information provision) Reference 1: Instructions for Package Inserts of Prescription Drugs (PSEHB Notification NO. 0608-1 by Director-General Pharmaceutical Safety and Environmental Health Bureau, Ministry of Health, Labour and Welfare dated June 8, 2017) Reference 2: Instructions for Package Inserts of Vaccines (PSEHB Notification NO. 1227 by Director-General Pharmaceutical Safety and Environmental Health Bureau, Ministry of Health, Labour and Welfare dated December 27, 2017 |
|
| February 28, 2019 PSEHB/PSD0228 No.1 PSEHB/PSD0228 No.2 |
Results of the Interim Report on the Use Results Surveys of Osimertinib Mesilate Preparations (request for circulation) | |
| January 29, 2019 HPB/GAD0129 No.2 HPB/EAD0129 No.1 PSEHB/GAD0129 No.2 PSEHB/CND0129 No.1 |
Efforts to Ensure Identification etc. of Pharmaceuticals | |
| November 26, 2018 PSEHB/PSD1126 No.2 |
Efforts to Raise Awareness of Precautions regarding Anti-Influenza Drugs | |
| November 14, 2018 Administrative Notice |
Handling of Freeze-dried BCG Vaccines (for percutaneous use; for single dose) (points for consideration) | |
| November 9, 2018 PSEHB/PED1109 No.6 PSEHB/PSD1109 No.4 PSEHB/CND1109 No.1 |
Establishment of Management Indicators for Carcinogenic Substances contained in Angiotensin II-receptor Antagonists (request) | |
| November 8, 2018 Administrative Notice |
Quality of Diluent for Reconstitution of Freeze-dried BCG Vaccines (for percutaneous use; for single dose) | |
| October 5, 2018 Administrative Notice |
Results of Deliberation of the FY 2018 Subcommittee on Drug Safety of the Committee on Drug Safety (the 8th meeting) on the Detection of Carcinogenic Substances from Valsartan Preparations | |
| May 29, 2018 HPB/GAD/MSPO 0529 No.1 PSEHB/PSD0529 No.1 |
Guidance concerning Appropriate Use of Medication by Elderly Patients (general) | |
| May 25, 2018 PSEHB/PED0525 No.3 PSEHB/PSD0525 No.1 |
Points for Consideration concerning the Use of Tofacitinib Citrate Preparations | |
| April 13, 2018 PSEHB0413 No.4 |
Self-inspections of Pharmaceuticals, etc. Manufactured from Materials, etc. Derived from Species of the Finnish Cervidae Family | |
| March 29, 2018 PSEHB/PED0329 No.17 PSEHB/PSD0329 No.1 |
Precautions Included in Package Inserts, etc. of OTC Crude Drug Products | |
| March 27, 2018 PSEHB/PSD0327 No.1 |
Revisions of Precautions for Antimicrobials | |
| February 1, 2018 PSEHB/PSD0201 No.1 PSEHB/BBPD0201 No.1 |
Dissemination of Safety Measures Applicable when Using Blood Products for Transfusion | |
| January 24, 2018 PSEHB/PSD0124 No.1 PSEHB/PSD0124 No.2 |
Results of the Interim Report on the Use Results Surveys of Osimertinib Mesilate Preparations (request for circulation) | |
| January 19, 2018 PSEHB/PED0119 No.1 PSEHB/PSD0119 No.1 |
Points for Consideration concerning the Use of Inotuzumab Ozogamicin (genetical recombination) Preparations | |
| January 16, 2018 PSEHB/PED0116 No.1 PSEHB/PSD0116 No.1 |
Correction of the "Partial Revision of Precautions Included in Package Inserts, etc. for Cold Medicines, etc." Appendix: Precautions included in Package Inserts, etc. for Cold Medicines, etc. |
|
| December 25, 2017 PSEHB/PED1225 No.5 PSEHB/PSD1225 No.1 |
Points for Consideration concerning the Use of Olanzapine Preparations | |
| December 25, 2017 PSEHB/PED1225 No.1 |
Points for Consideration concerning the Use of Eculizumab (genetical recombination) Preparations | |
| December 4, 2017 PSEHB/PSD1204 No.2 PSEHB/BBPD 1204 No.1 |
Dissemination of Safety Measures concerning the Use of Concentrated Human Platelet Preparations | |
| November 28, 2017 PSEHB/PSD1128 No.2 PSEHB/PSD1128 No.3 |
Dissemination of Information concerning the Revisions of Precautions for Gadolinium-based Contrast Agents (request) | |
| November 27, 2017 PSEHB/PSD1127 No.8 |
Efforts to Raise Awareness of the Precautions for Anti-Influenza Drugs | |
| October 17, 2017 PSEHB/PED1017 No.2 PSEHB/PSD1017 No.3 |
Partial Revision of Precautions Included in Package Inserts, etc. for Cold Medicines, etc. Appendix: Precautions included in Package Inserts, etc. for Cold Medicines, etc. * Abolished on Jan. 16, 2018 |
|
| September 27, 2017 PSEHB/PED0927 No.11 |
Request for Cooperation in Post-marketing Surveillance and Proper Use of Glecaprevir Hydrate/Pibrentasvir Preparations | |
| September 27, 2017 PSEHB/PED0927 No.7 |
Points for Consideration concerning the Use of Cedar Pollen Extract Tablets for Sublingual Administration | |
| September 27, 2017 PSEHB/PED0927 No.4 PSEHB/PSD0927 No.1 |
Points for Consideration concerning the Use of Bezlotoxumab (genetical recombination) | |
| July 4, 2017 PSEHB/SD0704 No.2 PSEHB/SD0704 No.3 |
Dissemination of Information concerning the Revisions of Precautions for Medicines Containing Codeine Phosphate or Dihydrocodeine Phosphate (request) | |
| July 4, 2017 PSEHB/SD0704 No.8 PSEHB/PED0704 No.5 |
Partial Revision of Precautions Included in Package Inserts, etc. of Cold Medicines, etc. Appendix: Precautions included in Package Inserts, etc. for Cold Medicines, etc. * Abolished on Oct. 17, 2017 |
|
| July 3, 2017 PSEHB/PED0703 No.4 PSEHB/SD0703 No.1 |
Points for Consideration concerning the Use of Quetiapine Fumarate Extended Release Preparations | |
| March 30, 2017 PSEHB/PED0330 No.1 |
Points for Consideration concerning the Use of Forodesine Hydrochloride Preparations | |
| March 21, 2017 PSEHB/SD0321 No.2 PSEHB/SD0321 No.3 |
Dissemination of Information concerning the Revisions of Precautions for Hypnotic-sedatives, Anxiolytics, and Antiepileptics (request) | |
| November 25, 2016 PSEHB/SD1125 No.2 |
Dissemination of Information concerning the Revisions of Precautions for Milnacipran Hydrochloride, Duloxetine Hydrochloride, and Venlafaxine Hydrochloride (request) | |
| November 22, 2016 PSEHB/SD1122 No.2 PSEHB/SD1122 No.3 |
Dissemination of Information concerning the Revisions of Precautions for Polaprezinc (request) | |
| November 18, 2016 PSEHB/SD1118 No.8 |
Efforts to Raise Awareness of the Precautions for Anti-Influenza Drugs | |
| October 24, 2016 PSEHB/SD1024 No.1 PSEHB/SD1024 No.2 PSEHB/SD1024 No.3 |
Dissemination of Information concerning Fulminant Type 1 Diabetes when Using Pembrolizumab (genetical recombination) Preparations | |
| October 18, 2016 PSEHB/SD1018 No.4 |
Dissemination of Information concerning the Revisions of Precautions for Warfarin Potassium and Azole Antifungal Agents (oral and injectable dosage forms) (request) | |
| October 18, 2016 Administrative notice |
Revisions of Precautions for Preparations Containing Pioglitazone Hydrochloride | |
| September 28, 2016 PSEHB/PED0928 No.1 |
Points for Consideration concerning the Use of Ponatinib Hydrochloride Preparations | |
| July 22, 2016 PSEHB/SD0722 No.3 PSEHB/SD0722 No.4 |
Precautions concerning Interstitial Lung Disease when Administering Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (request) | |
| May 31, 2016 PSEHB/SD0531 No.3 |
Revisions of Precautions | |
| May 31, 2016 PSEHB/SD0531 No.2 |
Revisions of Precautions for Local Antimicrobial Agents Containing Chlorhexidine Gluconate | |
| May 19, 2016 PSEHB/PED0519 No.1 PSEHB/SD0519 No.1 |
Dissemination of Information concerning Safety Management on Teratogenicity of Mycophenolate Mofetil Preparations | |
| April 21, 2016 Administrative Notice |
Revisions of Precautions for OTC Drugs Containing Pseudoephedrine Hydrochloride or Pseudoephedrine Sulfate | |
| January 28, 2016 PSEHB/SD0128 No.1 PSEHB/SD0128 No.2 PSEHB/SD0128 No.3 |
Dissemination of Information concerning Fulminant Type 1 Diabetes when Using Nivolumab (genetical recombination) Preparations (request) | |
| October 13, 2015 PSEHB/SD1013 No.1 |
Revision of the Package Insert for Injections Containing Benzyl Alcohol as an Excipient | |
| April 23, 2015 Administrative Notice |
Q&A concerning Precautions Included in Package Inserts etc. of Cold Medicines etc. | |
| April 6, 2015 Administrative Notice |
Revisions of Precautions | |
| April 1, 2015 PFSB/SD0401 No.2 PFSB/ELD0401 No.9 |
Partial Revision of Precautions Included in Package Inserts, etc. of Cold Medicines etc. Appendix: Precautions included in Package Inserts, etc. for Cold Medicines, etc. * Abolished on July 4, 2017 |
|
| January 22, 2015 Administrative Notice |
Concerning Changes to the Content of Revisions of Precautions | |
| October 21, 2014 PFSB/SD1021 No.1 |
Revisions of Precautions for Acetaminophen (prescription drugs) | |
| December 2, 2013 PFSB/SD1202 No.2 |
Compliance with the Ministerial Ordinance on Good Vigilance Practices for Marketing Authorization Holders (MAHs) (to relevant organizations such as the Federation of Pharmaceutical Manufacturers' Associations of Japan [FPMAJ]) | |
| December 2, 2013 PFSB/SD1202 No.1 |
Compliance with the Ministerial Ordinance on Good Vigilance Practices for Marketing Authorization Holders (MAHs) (to prefectural governors) | |
| August 6, 2013 Administrative Notice |
Revisions of Precautions for OTC Drugs Containing Pseudoephedrine Hydrochloride or Pseudoephedrine Sulfate | |
| March 26, 2013 Administrative Notice |
Co-administration of Angiotensin-converting Enzyme Inhibitors (ACE Inhibitors) or Angiotensin II Receptor Blockers (ARB) with Aliskiren Fumarate | |
| March 11, 2013 PFSB 0311 No.7 |
Enforcement of the Ministerial Ordinance on Partial Revision of Ministerial Ordinance on Good Vigilance Practice (GVP) for Drugs, Quasi-drugs, Cosmetics, and Medical Devices, and Ministerial Ordinance on Good Post-marketing Study Practice (GPSP) for Drugs | |
| January 25, 2013 Administrative Notice |
Language related to Renal Impairment in the Precautions for OTC Drugs (Response) | |
| December. 11, 2012 PFSB 1211 No.8 |
Self-inspection of Pharmaceuticals and Medical Devices, etc. Manufactured using Materials Derived from Bovine Specimens, etc. Originating from Brazil | |
| June 6, 2012 Administrative Notice |
Additional Ingredient Labeling Requirements for Drugs, Quasi-drugs, and Cosmetics Containing Cochineal-derived Substances, etc. | |
| May 11, 2012 PFSB/ELD0511 No.5 PFSB/SD0511 No.3 PFSB/CND0511 No.2 |
Medicated Gelatin, etc. Containing Chromium Exceeding the Maximum Safe Level Standard in China (Attention: Commissioners of Prefectural Health Supervising Departments, Commissioners of Prefectural/Municipal/Special Ward Health Departments (Bureaus) Reference: (Chairmen of the Federation of Pharmaceutical Manufacturers' Associations of JAPAN, Japan Pharmaceutical Manufacturers Association (JPMA), Japan Bulk Pharmaceutical Manufacturers Association, The Pharmaceutical Research and Manufacturers of America (PhRMA) Japan-based Executive Committee (JBEC), American Chamber of Commerce in Japan (ACCJ) Pharmaceuticals Subcommittee, European Federation of Pharmaceutical Industries and Associations (EFPIA) Japan, Japan Cosmetic Industry Association (JCIA), The Japan Federation of Medical Devices Associations (JFMDA), American Medical Devices and Diagnostics Manufacturers' Association (AMDD), and the European Business Council in Japan Medical Equipment & Diagnostics Committee) |
|
| May 11, 2012 PFSB/ELD0511 No.1 PFSB/SD0511 No.1 |
Ingredient Labeling Requirements for Drugs, Quasi-drugs, and Cosmetics Containing Cochineal-derived Substances, etc. | |
| April 19, 2012 PFSB/ELD0419 No.18 PFSB/SD0419 No.4 PFSB/CND0419 No.1 |
Quality and Safety Assurance of Pharmaceuticals etc. using Gelatin Capsules (Attention to: Commissioners of Prefectural Health Supervising Departments, Commissioners of Cities with Public Health Centers and Special Wards) Reference: (Chairmen of the Federation of Pharmaceutical Manufacturers' Associations of JAPAN, Japan Pharmaceutical Manufacturers Association (JPMA), Japan Bulk Pharmaceutical Manufacturers Association, The Pharmaceutical Research and Manufacturers of America (PhRMA) Japan Based Executive Committee (JBEC), The American Chamber of Commerce in Japan Pharmaceuticals subcommittee, European Federation of Pharmaceutical Industries and Associations (EFPIA) Japan) |
|
| February 14, 2012 PFSB/SD0214 No.9 |
Efforts to Raise Awareness of the Precautions for Anti-Influenza Drugs | |
| January 20, 2012 PFSB/ELD0120 No.1 PFSB/CND0120 No.1 |
Points for Consideration concerning the Use of Lysozyme Hydrochloride Preparations | |
| December 12, 2011 PFSB/ELD1212 No.1 PFSB/SD1212 No.1 PFSB/CND1212 No.2 |
Points for Consideration concerning the Use of Warfarin Potassium Preparations | |
| November 22, 2011 PFSB/SD1122 No.7 |
Efforts to Raise Awareness of the Precautions for Anti-Influenza Drugs | |
| July 29, 2011 PFSB/SD0729 No.1 |
Meeting to Exchange Opinions concerning Promotion of the use of the PMDA medi-navi (request) Appendix: Summary of the Meeting to Exchange Opinions concerning Promotion of the use of the Pharmaceutical and Medical Device Information E-mail Alert Service |
|
| July 15, 2011 PFSB/SD0715 No.3 |
Provision of Drug Safety Information | |
| March 1, 2011 PFSB/SD0301 No.1 PFSB/SD0301 No.2 |
Efforts to Promote Proper Use of Gemtuzumab Ozogamicin (genetical recombination) Reference: Report on investigation results regarding the safety of pharmaceutical products, etc. Related information: Regulatory actions taken in the US related to Mylotarg for Injection 5mg (nonproprietary name: gemtuzumab ozogamicin) (June 22, 2011) |
|
| January 7, 2011 PFSB/SD0107 No.1 |
Change in Category Listing for OTC Drugs | |
| December 22, 2010 PFSB/GAD 1222 No.1 PFSB/SD1222 No.1 |
Precautions concerning Marketing of OTC Cold Medicines with Pediatric Use (Internal Use), Antitussive and Expectorant Drugs (Internal use), and Medicines for Rhinitis (request for circulation) | |
| October 26, 2010 PFSB/SD1026 No.3 |
Periodic Report on the Safety of Drugs and Quasi-drugs Containing DEET | |
| June 14, 2010 PFSB/ELD0614 No.10 |
Revision of Package Inserts concerning Continuous Use of Atomoxetine Hydrochloride Preparations in ADHD Patients from Childhood to Adulthood | |
| June 1, 2010 PFSB/GAD 0601 No.6 PFSB/SD0601 No.3 |
Points for Consideration regarding Marketing of OTC Antitussives and Expectorants (internal use) Containing Codeine Phosphate Hydrate and Dihydrocodeine Phosphate | |
| March 1, 2010 PFSB/ELD0301 No.1 PFSB/SD0301 No.5 PFSB/CND 0301 No.6 |
Points for Consideration concerning the Use of Distigmine Bromoide Preparations (internal use) | |
| January 13, 2010 PFSB/SD0113 No.1 |
Efforts to Raise Awareness of the Precautions of Peramivir Preparations and Request regarding the Precautions After the Start of Treatment for Influenza A (H1N1) | |
| January 13, 2010 PFSB/ELD0113 No.1 PFSB/SD0113 No.2 |
Post-marketing Safety Measures, etc. related to Peramivir Preparations | |
| January 13, 2010 PFSB/ELD0113 No.2 PFSB/SD0113 No.3 |
Request for Cooperation in Determining Total Usage Statistics for Peramivir Preparations | |
| November 30, 2009 Administrative Notice |
Precautions After the Start of Influenza A (H1N1) Treatment | |
| October 9, 2009 PFSB/SD1009 No.1 |
Safety Measures related to Influenza A (H1N1) Vaccines | |
| September 4, 2009 PFSB/SD0904 No.1 PFSB/SD0904 No.2 PFSB/SD0904 No.3 |
Safety Measures related to Anti-Influenza Drugs in connection with the Influenza A (H1N1) Epidemic | |
| September 4, 2009 PFSB/SD0904 No.4 PFSB/SD0904 No.5 PFSB/SD0904 No.6 |
Efforts to Raise Awareness of the Precautions for Anti-Influenza Drugs | |
| March 24, 2006 PFSB/SD No.0324006 |
Efforts to Optimize the Provision of Information concerning Generic Drugs | |
| October 16, 2008 PFSB/ELD No.0716001 |
Points for Consideration concerning the Use of Pirfenidone Preparations | |
| July 16, 2008 PFSB/ELD No.0716001 |
Points for Consideration concerning the Use of Sodium Risedronate Hydrate Preparations | |
| October 26, 2007 PFSB/GAD No.1026001 PFSB/ELD No.1026002 PFSB/SD No.1026001 PFSB/CND No.1026003 |
Points for Consideration concerning the Use of Methylphenidate Hydrochloride Preparations | |