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- PMDA’s Efforts to Combat COVID-19
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PMDA’s Efforts to Combat COVID-19
PMDA’s Efforts to Combat COVID-19
- For Your Access to Japanese Clinical Trial/Clinical Research Information
- First Approval of Antigen Test for COVID-19
- Special Approval for Emergency on Remdesivir for COVID-19
- Four IVDs Approvals for COVID-19 and Response to the Increased Ventilator Demand
- PMDA Takes Further Steps to Speed up Clinical Development of COVID-19 Products
- PMDA pledge to tackle COVID-19 Pandemic
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 |
|---|---|---|---|
| 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 |
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 Kitv | Sysmex Corporation | March 27, 2020 | |
| SARS-CoV-2 nucleic acid kit | Loopamp Novel Coronavirus 2019 (SARS-CoV-2) Detection Kit | Eiken Chemical Co., Ltd. | March 31, 2020 | |
| SARS-CoV-2 nucleic acid kit | cobas SARS-CoV-2 | Roche Diagnostics K.K. | April 7, 2020 | |
| SARS-CoV-2 nucleic acid kit | TaqPath Real Time PCR Reagent Kit for SARS-CoV-2 | Life Technologies Japan Ltd. | April 20, 2020 | |
| SARS-CoV-2 nucleic acid kit | Xpert® Xpress SARS-CoV-2 ‘Cepheid’ | Beckman Coulter, Inc. | May 8, 2020 | |
| 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 |