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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

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.
 

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PMDA’s Efforts to Combat COVID-19
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