Regulatory Challenge againstCOVID‐19
Transcript of Regulatory Challenge againstCOVID‐19
Regulatory Challengeagainst COVID‐19
1
MATSUKURA YujiDeputy Director,
Office of International Regulatory Affairs,Pharmaceutical Safety and Environmental Health Bureau,
MHLW
8th Joint Conference of Taiwan and Japan on Medical Products Regulation on October 15, 2020
Contents
3)Approved Medical Products for COVID‐19
2)Regulatory Flexibilities/Agilities during COVID‐19
1)Situation of COVID‐19 in Japan
4) International Cooperation under ICMRA
5) Challenges for COVID‐19 Vaccines
8th Joint Conference of Taiwan and Japan on Medical Products Regulation on October 15, 20202
Situation of COVID‐19 in JapanNumber of Cases (As of 0:00, September 28, 2020)
State of Emergency Declared on April 7
‐ The areas were Saitama, Chiba, Tokyo, Kanagawa, Osaka, Hyogo and Fukuoka Prefectures.‐ The areas were expanded to all 47 prefectures, on April 16.
Lifted on May 25‐ The analysis and assessment was conducted and the implementation of emergency measures are deemed no longer necessary.
Number of CasesPCR tested 1,957,973
PCR tested positive 82,131
Need inpatient treatment (current) 5,579
Death 1,548(54 cases under confirmation)
https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/newpage_00032.html
8th Joint Conference of Taiwan and Japan on Medical Products Regulation on October 15, 20203
Regulatory Flexibilities/Agilities during COVID‐19Clinical Trial, GCP
Document Title (Links are only in Japanese) Summary of Flexibilities/Agilities
Handling on clinical trial notifications of COVID‐19 (Administrative Notice dated March 19, 2020)https://www.mhlw.go.jp/hourei/doc/tsuchi/T200323I0040.pdf
Clinical trials on COVID‐19 can be started without waiting 30 days after the submission of clinical trial notification if investigation by PMDA is completed.
Handling on review of COVID‐19 clinical trials by Institutional Review Board (IRB) (Administrative Notice dated April 1, 2020)https://www.pmda.go.jp/files/000234902.pdf
The IRB meeting of each medical institution can be held by e‐mail and online basis other than face‐to‐face. It can be applied only when the review is urgently needed. The details of meeting must be recorded and stored.
Handling on the storage of informed consent forms during clinical trials (Administrative Notice dated April 7, 2020)https://www.mhlw.go.jp/hourei/doc/tsuchi/T200408I0010.pdf
The following documents can be regard as original documents if it is difficult to store the signed informed consent.1. Copies – when they are making the signed informed consent in writing, the copies certified as having made based on the process that is established to guarantee the identity with the original. 2. Electric signature – Only when the documents with the sign can be stored based on the prepared procedure manual with keeping their readability, and in case it is possible to deliver its copy to the subject.
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Regulatory Flexibilities/Agilities during COVID‐19Clinical Trial, GCP (continued)
Document Title (Links are only in Japanese) Summary of Flexibilities/Agilities
Handling of implementation guidelines for document‐based conformity inspection and GCP on‐site inspection for the time being associated with COVID‐19 (Administrative Notice dated May 12, 2020)https://www.pmda.go.jp/files/000235011.pdf
1. Considering the infection risk, GLP/GCP document‐based conformity inspection and GCP on‐site inspection can be postponed.2. The Authority can conduct remote inspections to Sponsors.3. Confirmation of management on clinical trial sites by sponsor can be done without GCP on‐site inspection. However, when there are any serious concern, sponsor should undergo on‐site inspection after the pandemic is settled.4. Sealing on documents is not needed.
Q&A on clinical trial of drugs, medical devices, and regenerative medical products under the influence of COVID‐19https://www.pmda.go.jp/files/000235164.pdf
Will be updated occasionally1. Delivery of the investigational medicinal products2. IRB 3. On‐site monitoring4. protocol deviations5. Examinations specified in the clinical trial protocoletc.
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Regulatory Flexibilities/Agilities during COVID‐19Marketing Approval
Document Title (Links are only in Japanese) Summary of Flexibilities/Agilities
Handling on regulatory reviews of drugs, medical devices, IVDs, and regenerative medical products for the time being associated with COVID‐19 (Administrative Notice dated April 13, 2020)https://www.mhlw.go.jp/hourei/doc/tsuchi/T200415I0010.pdf
1. Prioritize examination, investigation and inspection of Covid‐19 medicines2. Promote IT means for exchange of information, communication and documentation with applicants and manufacturers due to Covid‐19 pandemic3. Promote the IT measures for all medicines under evaluation
Handling on regulatory reviews of disinfectant as newly designated quasi‐drugs for the time being associated with COVID‐19 (Administrative Notice dated April 24, 2020) https://www.pmda.go.jp/files/000234940.pdf
In order to expedite the regulatory reviews on disinfectant, the sponsor which request for the expedited regulatory process must inform MHLW when they apply for an approval. Also, they must respond to query from PMDA as soon as possible.
Handling on regulatory reviews of medical products against COVID‐19 (PSEHB/PED Notification No. 0512‐4, PSEHB/MDED Notification No.0512‐1 May 12, 2020)https://www.pmda.go.jp/files/000235010.pdf
The notice describes priority review and flexibility on review process and dossiers of clinical data for medical products against COVID‐19.MA applicants can submit, instead of the clinical trial data conducted in compliance with the related law, the clinical study data funded by public sector such as MHLW,
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Clinical trials for COVID‐19 products are allowed to start before expiration of waiting period of 30 days
Submission of Initial Clinical Trial
Notification Start Clinical Trial
Normal candidate product
COVID-19 candidate product
30days are
required
<30days are
allowed
Early Patient Access
Administrative Notice issued on 19th March, 2020by the Pharmaceutical Evaluation Div. / the Medical Device Evaluation Div.
Pharmaceutical Safety and Environmental Health Bureau MHLW
https://www.pmda.go.jp/english/int-activities/0001.pdf
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Approved Medical Products for COVID‐19
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 “Special Approval for Emergency” of the PMD Act)
Drugs
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Special Approval for Emergency on Remdesivir
Thai-Japan Bilateral Meeting (2020.07.15) 9
Novel InfluenzaNovel Influenza
Regulatory Submission by Gilead Sciences
Under article 14-3 of the PMD Act, a certain medical product may be approved under when① an emergency situation requires an unapproved medical product to be used to prevent damage to the public
health caused by the spread of diseases② such emergency situation cannot be managed appropriately by any means other than the use of the
unapproved product, and③ such product is legally available in a country with a regulatory system for medical products that is
equivalent to Japan
Cabinet Order was amended to expand the scope of Special Approval for Emergency to include the drugs for novel coronavirus
COVID-19COVID-19
May 2nd
May 4th
May 7th Discussed by Pharmaceutical Affairs and Food Sanitation Council of the MHLW
Special Approval for Emergency on Remdesivir
PMDA prepared the report for the available information, approval conditions etc..
https://www.pmda.go.jp/english/int-activities/0004.pdf
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Approved Medical Products for COVID‐19Medical DevicesJapanese Medical DeviceNomenclature (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
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
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
8th Joint Conference of Taiwan and Japan on Medical Products Regulation on October 15, 202010
Approved Medical Products for COVID‐19Medical Devices (continued)Japanese Medical DeviceNomenclature (JMDN) Brand Name Applicant Company Approval Date
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 S5LivaNova 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
8th Joint Conference of Taiwan and Japan on Medical Products Regulation on October 15, 202011
Approved Medical Products for COVID‐19In Vitro DiagnosticsJapanese Medical DeviceNomenclature (JMDN) Brand Name Applicant Company Approval Date
SARS‐CoV‐2 nucleic acid kit 2019‐nCoV Fluorescence Detection Real‐time RT‐PCR Kit 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
SARS‐CoV‐2 nucleic acid kit MEBRIGHT SARS‐CoV‐2 Kit Medical & Biological Laboratories Co., Ltd. May 21, 2020
8th Joint Conference of Taiwan and Japan on Medical Products Regulation on October 15, 202012
Approved Medical Products for COVID‐19In Vitro Diagnostics (continued)Japanese Medical DeviceNomenclature (JMDN) Brand Name Applicant Company Approval Date
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, 2020SARS‐CoV‐2 nucleic acid kit GENECUBE SARS‐CoV‐2 TOYOBO CO., LTD. July 2, 2020SARS‐CoV‐2 nucleic acid kit TRCReady SARS‐CoV‐2 Tosoh Corporation July 31, 2020SARS‐CoV‐2 antigen kit QuickNavi‐COVID19 Ag Denka Co., Ltd. August 11, 2020SARS‐CoV‐2 nucleic acid kit SmartAmp SARS‐CoV‐2 K.K. DNAFORM August 17, 2020SARS‐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
8th Joint Conference of Taiwan and Japan on Medical Products Regulation on October 15, 202013
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International Cooperation under ICMRA*
Meetings: Global regulatory workshop on COVID‐19 vaccine development
http://www.icmra.info/drupal/news/22june2020_2http://www.icmra.info/drupal/news/22june2020
Global regulatory workshop on COVID‐19 therapeutic developmenthttp://www.icmra.info/drupal/news/20july2020
Global regulatory workshop on COVID‐19 Real‐World Evidence and Observational Studieshttp://www.icmra.info/drupal/news/22july2020
*The International Coalition of Medicines Regulatory Authorities
Statements: ICMRA statement on COVID‐19: International regulators pledge
collective support to combat COVID‐19http://www.icmra.info/drupal/news/statement_on_COVID‐19
ICMRA statement on clinical trials: International regulators provide guidance on prioritization of COVID‐19 clinical trialshttp://www.icmra.info/drupal/news/statement_on_clinical_trials
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Challenges for COVID‐19 Vaccines Rapid and equitable access to the COVID‐19 vaccines, while ensuring
their effectiveness, safety and quality
Guidance on the COVID‐19 Vaccines (PMDA)https://www.pmda.go.jp/files/000236327.pdf
(Only in Japanese. English version is under preparation.)
Government of Japan has decided to join the COVAX facility mechanism.
Enhanced post‐marketing monitoring (safety, effectiveness)
International collaboration through ICMRA/WHO
8th Joint Conference of Taiwan and Japan on Medical Products Regulation on October 15, 202015
Thank you for your attention!多謝
8th Joint Conference of Taiwan and Japan on Medicinal Products Regulation8th Joint Conference of Taiwan and Japan on Medical Products Regulation on October 15, 202016