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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
- PMDA Reveals Principles on Evaluation of COVID-19 Vaccines
- PMDA to Offer Free Scientific Advice for COVID-19 Vaccines Development
- 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
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 | |
| Multiparameter monitor with critical parameters | IntelliVue Patient Monitors | Philips Japan, Ltd. | September 17, 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 |
*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 |
*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.