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PMDA’s Efforts to Combat COVID-19
PMDA’s Efforts to Combat COVID-19
Statement by the Chief Executive Dr. FUJIWARA
| Issue # | Title | Date |
|---|---|---|
| 9 | Special Approval for Emergency on First COVID-19 Vaccine in Japan | February 16, 2021 |
| 8 | PMDA Reveals Principles on Evaluation of COVID-19 Vaccines | October 12, 2020 |
| 7 | PMDA to Offer Free Scientific Advice for COVID-19 Vaccines Development | October 6, 2020 |
| 6 | For Your Access to Japanese Clinical Trial/Clinical Research Information | June 4, 2020 |
| 5 | First Approval of Antigen Test for COVID-19 | May 13, 2020 |
| 4 | Special Approval for Emergency on Remdesivir for COVID-19 | May 8, 2020 |
| 3 | Four IVDs Approvals for COVID-19 and Response to the Increased Ventilator Demand | April 21, 2020 |
| 2 | PMDA Takes Further Steps to Speed up Clinical Development of COVID-19 Products | April 10, 2020 |
| 1 | PMDA pledge to tackle COVID-19 Pandemic | March 31, 2020 |
For other statements announced by Chief Executive Dr. FUJIWARA, including those on non COVID-19 topics, please access this page.
Other Information
- Principles for the Evaluation of Vaccines Against the Novel Coronavirus SARS-CoV-2
- Principles for the Evaluation of Vaccines Against the Novel Coronavirus SARS-CoV-2 (Appendix 1) Evaluation of vaccines against variants
- Principles for the Evaluation of Vaccines Against the Novel Coronavirus SARS-CoV-2 (Appendix 2) Ethical Considerations for Subjects in Placebo-Controlled Studies
Approved Medical Products for COVID-19
The following products were approved for COVID-19 by the Ministry of Health, Labour and Welfare after March 2020 with prior scientific review by the PMDA.
For information of products under review by the PMDA or development by sponsors, please contact sponsors or developers of the product.
Drugs
| Active Ingredient | Brand Name | Applicant Company | Approval Date |
Other Information |
|---|---|---|---|---|
| Remdesivir | VEKLURY for Intravenous Injection | Gilead Sciences K.K. | May 7, 2020 (approved based on article 14-3 of the PMD Act, i.e, Special Approval for Emergency) |
Review Report |
| Baricitinib | Olumiant Tablets 2 mg / Olumiant Tablets 4 mg |
Eli Lilly Japan K.K. | April 23, 2021 | Review Report |
| Casirivimab(Genetical Recombination) and Imdevimab(Genetical Recombination) | RONAPREVE for Intravenous Infusion Set | Chugai Pharmaceutical Co., Ltd. | July 19, 2021 (approved based on article 14-3 of the PMD Act, i.e, Special Approval for Emergency) |
Review Report |
| Sotrovimab(Genetical Recombination) | XEVUDY for Intravenous Injection | GlaxoSmithKline K.K. | September 27, 2021 (approved based on article 14-3 of the PMD Act, i.e, Special Approval for Emergency) |
Vaccines
| Non-proprietary Name | Brand Name | Applicant Company | Approval Date |
Other Information |
|---|---|---|---|---|
| Coronavirus Modified Uridine RNA Vaccine (SARS-CoV-2) | COMIRNATY intramuscular injection | Pfizer Japan Inc. | February 14, 2021 (approved based on article 14-3 of the PMD Act, i.e, Special Approval for Emergency) |
Review Report |
| Coronavirus Modified Uridine RNA Vaccine (SARS-CoV-2) | COVID-19 Vaccine Moderna Intramuscular Injection | Takeda Pharmaceutical Co., Ltd.. | May 21, 2021 (approved based on article 14-3 of the PMD Act, i.e, Special Approval for Emergency) |
Review Report |
| COVID-19 (SARS-CoV-2) Vaccine (recombinant chimpanzee adenovirus vector) | VAXZEVRIA Intramuscular Injection | AstraZeneca K.K. | May 21, 2021 (approved based on article 14-3 of the PMD Act, i.e, Special Approval for Emergency) |
Review Report |
Medical Devices
| Japanese Medical Device Nomenclature (JMDN) |
Brand Name | Applicant Company | Approval Date | Other Information |
|---|---|---|---|---|
| Ventilator for general purpose | NKV-550 Series Ventilator System | NIHON KOHDEN CORPORATION |
April 24, 2020
|
|
| Bi-level positive airway pressure unit | Philips Respironics E30 ventilator | Philips Japan, Ltd. | May 1, 2020 | |
| Adult ventilator | Philips Trilogy Evo Series | Philips Japan, Ltd. | May 12, 2020 | |
| Software for diagnostic X-ray imaging system workstation | COVID-19 Pulmonary image analyses AI program “InferRead CT Pneumonia” | CES Descartes Co., Ltd. | June 3, 2020 | Partial change was approved on August 11. |
| Adult ventilator | Puritan Bennett 560 | Covidien Japan, Inc. | June 12, 2020 | |
| Adult ventilator | ACOMA Ventilator ART-21EX | ACOMA Medical Industry Co., Ltd | June 19, 2020 | |
| Heparin-coated aortic cannula | NSH heparin cannulae | SENKO MEDICAL INSTRUMENT Mfg. CO., LTD. | June 25, 2020 | |
| Software for diagnostic X-ray imaging system workstation | COVID-19 Pneumonia Image Analysis Program Ali-M3 |
MIC Medical Corp | June 29, 2020 | |
| Heart-lung bypass system | Heart Lung Machine S5 | LivaNova Deutschland GmbH (designated MAH*1: LivaNova (Japan) K.K.) |
July 13, 2020 | |
| Multiparameter monitor with critical parameters | IntelliVue Patient Monitors MX750/850 | Philips Japan, Ltd. | July 31, 2020 | |
| Ventilator for general purpose | Evita V Series | Dräger Japan Ltd. | September 14, 2020 |
|
| Neonatal/ pediatric ventilator |
Babylog VN Series | Dräger Japan Ltd. | September 14, 2020 |
|
| Multiparameter monitor with critical parameters | IntelliVue Patient Monitors | Philips Japan, Ltd. | September 17, 2020 |
|
| Software for central monitor with analytic capability | Philips Information Center | Philips Japan, Ltd. | November 4, 2020 |
|
| Ventilator for general purpose | Puritan Bennett 980 series | Covidien Japan, Inc. | January 8, 2021 |
|
| Syringe with Needle for general purpose | TOP Syringe MV | TOP Corporation | February 10, 2021 |
|
| Syringe with Needle for general purpose | FN SYRINGE | Terumo Corporation | March 5, 2021 |
|
| Syringe with Needle for general purpose | Nipro VA Syringe | NIPRO CORPORATION | March 25, 2021 |
|
| Syringe with Needle for general purpose | LDS Syringe | Smiths Medical Japan Ltd. | May 20, 2021 |
|
| Software for general-purpose imaging system workstation | COVID-19 Pneumonia Image Analysis Program FS-AI693 | FUJIFILM Corporation | May 26, 2021 |
|
| Single-use gas-powered pulmonary resuscitator | MicroVent V3 | Newton Co.,Ltd. | June 24, 2021 |
|
| Adult ventilator | elisa 300/500 | IMI Co., Ltd. | July 1, 2021 |
|
| General-purpose infusion pump | CAFTY PUMP S | AIR WATER INC. | July 7, 2021 |
*1 designated holder of marketing authorization for foreign-manufactured products
In Vitro Diagnostics
| Japanese Medical Device Nomenclature (JMDN) |
Brand Name | Applicant Company | Approval Date | Other Information |
|---|---|---|---|---|
| SARS-CoV-2 nucleic acid kit | 2019-nCoV Fluorescence Detection Real-time RT-PCR Kit | Sysmex Corporation | March 27, 2020 | *2 partial change was approved on June 2. |
| SARS-CoV-2 nucleic acid kit | Loopamp Novel Coronavirus 2019 (SARS-CoV-2) Detection Kit | Eiken Chemical Co., Ltd. | March 31, 2020 | *2 partial change was approved on June 2. |
| SARS-CoV-2 nucleic acid kit | cobas SARS-CoV-2 | Roche Diagnostics K.K. | April 7, 2020 | *2 partial change was approved on June 2. |
| SARS-CoV-2 nucleic acid kit | TaqPath Real Time PCR Reagent Kit for SARS-CoV-2 | Life Technologies Japan Ltd. | April 20, 2020 | *2 partial change was approved on June 2. |
| SARS-CoV-2 nucleic acid kit | Xpert Xpress SARS-CoV-2 ‘Cepheid’ | Beckman Coulter, Inc. | May 8, 2020 | *2 partial change was approved on June 2. |
| SARS-CoV-2 antigen kit | ESPLINE SARS-CoV-2 | Fujirebio Inc. | May 13, 2020 | Review Summary |
| SARS-CoV-2 nucleic acid kit | MEBRIGHT SARS-CoV-2 Kit | Medical & Biological Laboratories Co., Ltd. | May 21, 2020 | *2 partial change was approved on June 2. |
| SARS-CoV-2 nucleic acid kit / Virus Nucleic Acid Isolation Kit / Bacterial Nucleic Acid Isolation Kit |
FilmArray Respiratory Panel 2.1 | bioMérieux Japan Ltd. | June 2, 2020 | |
| SARS-CoV-2 antigen kit | Lumipulse SARS-CoV-2 Ag | Fujirebio Inc. | June 19, 2020 | |
| SARS-CoV-2 nucleic acid kit | GENECUBE SARS-CoV-2 | TOYOBO CO., LTD. | July 2, 2020 | |
| SARS-CoV-2 nucleic acid kit | TRCReady SARS-CoV-2 | Tosoh Corporation | July 31, 2020 | |
| SARS-CoV-2 antigen kit | QuickNavi-COVID19 Ag | Denka Co., Ltd. | August 11, 2020 |
|
| SARS-CoV-2 nucleic acid kit | SmartAmp SARS-CoV-2 | K.K. DNAFORM | August 17, 2020 |
|
| SARS-CoV-2 nucleic acid kit | Aptima SARS-CoV-2 | Hologic Japan, Inc. | August 18, 2020 |
|
| SARS-CoV-2 nucleic acid kit | Ampdirect 2019-nCoV Detection Kit | SHIMADZU CORPORATION | September 8, 2020 |
|
| SARS-CoV-2 nucleic acid kit | i-densy Pack SARS-CoV-2 | ARKRAY Factory, Inc. | September 8, 2020 |
|
| SARS-CoV-2 antigen kit | ImunoAce SARS-CoV-2/ Capilia SARS-CoV-2 | TAUNS LABORATORIES, INC. | October 13, 2020 |
|
| SARS-CoV-2 antigen kit | Lumipulse Presto SARS-CoV-2 Ag | Fujirebio Inc. | October 16, 2020 |
|
| SARS-CoV-2 nucleic acid kit | ID NOW COVID-19 | Abbott Diagnostics Medical Co., Ltd | October 20, 2020 |
|
| SARS-CoV-2 nucleic acid kit | GENECUBE HQ SARS-CoV-2 | TOYOBO CO., LTD. | October 23, 2020 |
|
| SARS-CoV-2 nucleic acid kit / Influenza virus nucleic acid kit |
SGNP nCoV/Flu PCR Detection Kit | SUDx-Biotec Corporation | October 23, 2020 |
|
| SARS-CoV-2 nucleic acid kit | Takara SARS-CoV-2 Direct PCR detection kit | Takara Bio Inc. | October 27, 2020 |
|
| Influenza virus kit | Lumipluse Flu- A&B |
Fujirebio Inc. | November 10, 2020 |
|
| SARS-CoV-2 antigen kit | HISCL SARS-CoV-2 Ag Assay Kit | Sysmex Corporation | November 10, 2020 |
|
| SARS-CoV-2 nucleic acid kit / Influenza virus nucleic acid kit |
cobas SARS-CoV-2 & Flu A/B | Roche Diagnostics K.K. | November 13, 2020 |
|
| SARS-CoV-2 nucleic acid kit | Illumina COVIDSeq Test | Illumina K.K. | December 8, 2020 |
|
| SARS-CoV-2 antigen kit | SARS-CoV-2 Antigen Rapid Test Kit Rapiim SARS-CoV-2-N PRT-C2N01A | CANON MEDICAL SYSTEMS CORPORATION | December 8, 2020 |
|
| SARS-CoV-2 nucleic acid kit | TaqPath SARS-CoV-2 Real Time PCR Reagent Kit HT | Life Technologies Japan Ltd. | December 17, 2020 |
|
| Influenza virus nucleic acid kit | GENECUBE FluA/B | TOYOBO CO., LTD | December 21, 2020 |
|
| Influenza virus kit | Lumipulse Presto Flu-A&B | Fujirebio Inc. | December 22, 2020 |
|
| Interferon-λ3 kit | HISCL IFN-λ3 Assay Kit | Sysmex Corporation | December 22, 2020 |
|
| SARS-CoV-2 nucleic acid kit | TRCReady SARS-CoV-2 i | TOSOH CORPORATION | January 19, 2021 |
|
| SARS-CoV-2 antigen kit | LumiraDx SARS-CoV-2 Ag Test Strip | LumiraDx Japan Co., Ltd. | January 19, 2021 |
|
| SARS-CoV-2 antigen kit | Panbio COVID-19 Ag Rapid Test Device (NASOPHARYNGEAL)/ PanbioTM COVID-19 Ag Rapid Test Device (NASAL) | Abbott Diagnostics Medical Co., Ltd. | January 22, 2021 |
|
| SARS-CoV-2 antigen kit | BD Veritor System for Rapid Detection of SARS-CoV-2 | Becton, Dickinson and Company | January 26, 2021 |
|
| SARS-CoV-2 antigen kit | PRORAST SARS-CoV-2 Ag ADTest SARS-CoV-2 |
ADTEC Corporation/LSI Medience Corporation | January 29, 2021 |
|
| Influenza virus nucleic acid kit | Loopamp Influenza B virus Detection Kit | Eiken Chemical Co., Ltd. | February 2, 2021 |
|
| SARS-CoV-2 antigen kit | SARS-CoV-2 Rapid Antigen Test | Roche Diagnostics K.K. | February 9, 2021 |
|
| SARS-CoV-2 nucleic acid kit | Simprova SARS-CoV-2 Detection Kit | Eiken Chemical Co., Ltd. | February 15, 2021 |
|
| SARS-CoV-2 nucleic acid kit | Takara SARS-CoV-2 & Flu Direct PCR detection kit | Takara Bio Inc. | February 15, 2021 |
|
| SARS-CoV-2 antigen kit | FUJI DRI-CHEM IMMUNO AG HANDY COVID-19 Ag | FUJIFILM Corporation | February 15, 2021 |
|
| Influenza virus nucleic acid kit | Simprova Influenza A virus Detection Kit | Eiken Chemical Co., Ltd. | February 15, 2021 |
|
| Influenza virus nucleic acid kit | Simprova Influenza B virus Detection Kit | Eiken Chemical Co., Ltd. | February 15, 2021 |
|
| SARS-CoV-2 nucleic acid kit | Smart Gene SARS-CoV-2 | MIZUHO MEDY Co.,Ltd | February 18, 2021 |
|
| SARS-CoV-2 antigen kit | Sofia SARS Antigen FIA | Quidel Corporation | February 18, 2021 |
|
| Influenza virus kit | HISCL Influenza Assay Kit | Sysmex Corporation | February 18, 2021 |
|
| SARS-CoV-2 nucleic acid kit | Alinity m system SARS-CoV-2 | Abbott Japan LLC | February 24, 2021 |
|
| SARS-CoV-2 antigen kit | Quick Chaser Auto SARS-CoV-2 | MIZUHO MEDY Co.,Ltd | March 2, 2021 |
|
| SARS-CoV-2 antigen kit | FUJI DRI-CHEM IMMUNO AG CARTRIDGE COVID-19 Ag | MIZUHO MEDY Co.,Ltd | March 2, 2021 |
|
| SARS-CoV-2 nucleic acid kit / Influenza virus nucleic acid kit | cobas Liat SARS-CoV-2 & Flu A/B | Roche Diagnostics K.K | March 12, 2021 |
|
| SARS-CoV-2 antigen kit | ALSONIC COVID-19 Ag | Alfresa Pharma Corporation | March 12, 2021 |
|
| SARS-CoV-2 antigen kit | KBM LineCheck nCoV (Stick Type) | KOHJIN BIO CO., LTD. | March 17, 2021 |
|
| SARS-CoV-2 antigen kit | Elecsys SARS-CoV-2 Antigen | Roche Diagnostics K.K. | March 17, 2021 |
|
| SARS-CoV-2 nucleic acid kit / Influenza virus nucleic acid kit | Xpert Xpress SARS-CoV-2/Flu‘Cepheid’ | Beckman Coulter, Inc. | April 14, 2021 |
|
| SARS-CoV-2 nucleic acid kit | DetectAmp SARS-CoV-2 RT-PCR Kit | Sysmex Corporation | April 14, 2021 |
|
| SARS-CoV-2 antigen kit / Influenza virus kit | COVID-19 and Influenza A+B Antigen Combo Test (NichireiBio) | Nichirei Biosciences Inc. | April 14, 2021 |
|
| SARS-CoV-2 antigen kit | ImmunoArrow SARS-CoV-2 | TOYOBO CO., LTD. | May 12, 2021 |
|
| SARS-CoV-2 antigen kit | VITROS SARS-CoV-2 Antigen | ORTHO-CLINICAL DIAGNOSTICS K.K | May 12, 2021 |
|
| SARS-CoV-2 nucleic acid kit | DELBio Dagane G1 SARS-CoV-2 Detection Kit | DELTA ELECTRONICS (JAPAN), INC. | May 27, 2021 |
|
| SARS-CoV-2 nucleic acid kit | SGNP nCoV PCR detection kit | SUDx-Biotec Corporation | May 27, 2021 |
|
| SARS-CoV-2 antigen kit | Check MR-COV19 | ROHTO Pharmaceutical Co., Ltd. | May 27, 2021 |
|
| SARS-CoV-2 nucleic acid kit | Swiftgene SARS-CoV-2 KAINOS | KAINOS Laboratories, Inc. | May 31, 2021 |
|
| SARS-CoV-2 nucleic acid kit | TRexGene SARS-CoV-2 Detection kit | TOYOBO CO., LTD. | June 3, 2021 |
|
| Th2 chemokine, TARC Kit | HISCL TARC Assay Kit | SHIONOGI & CO., LTD. | June 7, 2021 |
|
| SARS-CoV-2 antigen kit | RapidTesta SARS-CoV-2 | SEKISUI MEDICAL CO., LTD. | June 9, 2021 |
|
| SARS-CoV-2 antigen kit | AFIAS COVID-19 Ag Test Cartridge | TOKYO BOEKI MEDISYS INC. | June 16, 2021 |
|
| SARS-CoV-2 nucleic acid kit / Influenza virus nucleic acid kit | QuickNavi-Flu+COVID19 Ag | Denka Co., Ltd. | June 16, 2021 |
|
| SARS-CoV-2 nucleic acid kit | ELITe MGB SARS-CoV-2 PCR Detection Kit | Precision System Science Co., Ltd. | June 21, 2021 |
|
| SARS-CoV-2 nucleic acid kit | KANEKA Direct RT-PCR kit SARS-CoV-2 | KANEKA CORPORATION | June 25, 2021 |
|
| Interleukin-6 kit | Chemilumi IL6 (ADVIA Centaur/Atellica IM IL6) |
Siemens Healthcare Diagnostics K.K. |
July 2, 2021 |
|
| SARS-CoV-2 antigen kit | STANDARDTM Q COVID-19 Ag Test |
MALCOM COMPANY LIMITED | August 13, 2021 |
|
| SARS-CoV-2 antigen kit / Influenza virus kit | ESPLINE SARS-CoV-2&FLU A+B | FUJIREBIO INC. | August 13, 2021 |
|
| SARS-CoV-2 antigen kit | Quampas COVID-19 Antigen Test Kit | Cellspect Co.,Ltd. | September 14, 2021 |
|
| SARS-CoV-2 antigen kit | Immunofine SARS-COV-2 | Nichirei Biosciences Inc. | September 14, 2021 |
|
| SARS-CoV-2 antigen kit | CL AIA-PACK SARS-CoV-2-Ag | TOSOH CORPORATION | September 14, 2021 |
*2 Due to the addition of specimen types to COVID-19 Manual by the National Institute of Infectious Diseases, partial change was approved on June 2 to add saliva as a specimen type to those already approved, e.g, specimen obtained from bronchoalveolar lavage and nasopharyngeal swabs.
International Cooperation
The PMDA has been discussing the regulatory considerations for anticipated medical products for COVID-19 under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA). The ICMRA is a voluntary, executive-level, strategic coordinating, advocacy and leadership entity of regulatory authorities that work together.