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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
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
Remdesivir VEKLURY for Intravenous Injection Gilead Sciences K.K. May 7, 2020
(approved based on article 14-3 of the PMD Act)

 

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
 

*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
 

*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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