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April 11, 2024
RS
Recent Publications by PMDA Staffs updated
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April 9, 2024
JP
Press Release regarding international activities related to Pharmacopoeia posted
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March 7, 2024
Pub cmt
JP Drafts (March 2024) posted
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February 22, 2024
JP
PDG October 2023 Meeting Highlights posted
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December 27, 2023
JP
Implementation of PDG harmonized texts into Japanese Pharmacopoeia (General Chapters) updated
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December 7, 2023
Pub cmt
JP Drafts (December 2023) posted
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December 7, 2023
Sci board
The 4th Subcommittee on Cell and Gene Therapy Products Produced in vivo
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December 1, 2023
JP
PDG (Pharmacopoeial Discussion Group) Stage 2 Drafts (December, 2023) posted
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October 27, 2023
JP
PDG October 2023 Press Release posted
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October 6, 2023
JP
JP Frequently Asked Questions Q11~Q13 updated
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October 6, 2023
Sci board
The 3rd Subcommittee on Cell and Gene Therapy Products Produced in vivo
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September 11, 2023
Sci board
The 2nd Subcommittee on Cell and Gene Therapy Products Produced in vivo
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September 7, 2023
Pub cmt
JP Drafts (September 2023) posted
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August 29, 2023
Sci board
The 1st Subcommittee on Cell and Gene Therapy Products Produced in vivo
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August 28, 2023
Sci board
The 6th Subcommittee on Software as a Medical Device Utilizing AI and Machine Learning
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August 4, 2023
Sci board
The 46th Science Board Meeting
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July 7, 2023
JP
Implementation of PDG harmonized texts into Japanese Pharmacopoeia (Monographs) updated
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June 30, 2023
JP
JP 18th Edition Supplement I (English version) posted
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May 17, 2023
Sci board
The 4th Subcommittee on Software as a Medical Device Utilizing AI and Machine Learning
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April 11, 2023
Sci board
The 5th Subcommittee on Software as a Medical Device Utilizing AI and Machine Learning
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March 7, 2023
Pub cmt
JP Drafts (March 2023) No.1 posted
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March 7, 2023
Pub cmt
JP Drafts (March 2023) No.2 posted
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February 27, 2023
Sci board
The 44th Science Board Meeting
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February 20, 2023
Sci board
The 3rd Subcommittee on Software as a Medical Device Utilizing AI and Machine Learning
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January 17, 2023
Sci board
The 45th Science Board Meeting
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December 28, 2022
JP
Schedule of JP18-II Publication posted
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December 21, 2022
Sci board
The 1st Subcommittee on Software as a Medical Device Utilizing AI and Machine Learning
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December 7, 2022
Pub cmt
JP Drafts (December 2022) posted
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November 30, 2022
Sci board
The 2nd Subcommittee on Software as a Medical Device Utilizing AI and Machine Learning
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November 15, 2022
Sci board
The 6th Subcommittee on Therapeutic Products Based on Extracellular Vesicles (EVs) Including Exosomes
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August 22, 2022
Sci board
The 5th Subcommittee on Therapeutic Products Based on Extracellular Vesicles (EVs) Including Exosomes
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August 2, 2022
Sci board
The 43rd Science Board Meeting
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April 11, 2022
Sci board
The 4th Subcommittee on Therapeutic Products Based on Extracellular Vesicles (EVs) Including Exosomes
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March 30, 2022
Sci board
The 42nd Science Board Meeting
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February 15, 2022
RS
Recent Presentation by PMDA Staffs updated
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January 24, 2022
Sci board
The 41st Science Board Meeting
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January 24, 2022
Sci board
The 3rd Subcommittee on Therapeutic Products Based on Extracellular Vesicles (EVs) Including Exosomes
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December 24, 2021
Sci board
The 40th Science Board Meeting
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December 7, 2021
Pub cmt
JP Drafts (December 2021) posted
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November 8, 2021
Pub cmt
JP Drafts (November 2021) posted
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November 8, 2021
Pub cmt
JP Drafts (September 2021) No.2 updated
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November 2, 2021
RS
PMDA Guidance on Patient Participation
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October 8, 2021
Sci board
The 2nd Subcommittee on Therapeutic Products Based on Extracellular Vesicles (EVs) Including Exosomes
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October 5, 2021
Sci board
The 7th Subcommittee on Microbiome
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September 7, 2021
Pub cmt
JP Drafts (September 2021) No.1 posted
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August 13, 2021
Sci board
The 1st Subcommittee on Therapeutic Products Based on Extracellular Vesicles (EVs) Including Exosomes
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August 3, 2021
Sci board
The 6th Subcommittee on Microbiome
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June 7, 2021
Pub cmt
JP Drafts (June 2021) No.2 posted
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June 7, 2021
Pub cmt
JP Drafts (June 2021) No.1 posted
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May 19, 2021
RS
Update the page for RWD WG：MHLW notifications on Registry utilization and data reliability
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May 19, 2021
Sci board
The 5th Subcommittee on Microbiome
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May 12, 2021
Sci board
The 39th Science Board Meeting
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April 7, 2021
JP
Information on implementation of ICH-Q3D into the Japanese Pharmacopoeia posted
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March 31, 2021
Sci board
The 38th Science Board Meeting
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March 12, 2021
Sci board
The 4th Subcommittee on Microbiome
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March 5, 2021
Pub cmt
JP Drafts (March 2021) posted
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January 27, 2021
Sci board
The 3rd Subcommittee on Microbiome
-
January 26, 2021
Sci board
The 7th Subcommittee on Computer Simulation
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November 17, 2020
Sci board
The 6th Subcommittee on Computer Simulation
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November 5, 2020
Sci board
The 2nd Subcommittee on Microbiome
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October 12, 2020
Sci board
The 5th Subcommittee on Computer Simulation
-
September 11, 2020
Sci board
The 37th Science Board Meeting
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September 7, 2020
Pub cmt
JP Drafts (September 2020) posted
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August 24, 2020
Sci board
The 4th Subcommittee on Computer Simulation
-
August 18, 2020
Sci board
The 1st Subcommittee on Microbiome
-
July 8, 2020
Sci board
The 3rd Subcommittee on Computer Simulation
-
June 23, 2020
Sci board
The 36th Meeting of the Science Board
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June 5, 2020
Pub cmt
JP Drafts (June 2020) posted
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May 14, 2020
JP
JP17 Updated Errata, JP17-1 Errata, and JP17-2 Errata Posted
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March 11, 2020
Sci board
The 2nd Subcommittee on Computer Simulation
-
March 11, 2020
Sci board
The 1st Subcommittee on Computer Simulation
-
March 6, 2020
Pub cmt
JP Drafts (March 2020) No.1 posted
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March 6, 2020
Pub cmt
JP Drafts (March 2020) No.2 posted
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February 17, 2020
Sci board
The 35th Meeting of the Science Board
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December 6, 2019
Pub cmt
JP Drafts (December 2019) posted
-
November 8, 2019
Pub cmt
JP Drafts (November 2019) posted
-
November 5, 2019
Sci board
The 5th Subcommittee on Genome Editing
-
October 16, 2019
Sci board
The 34th Meeting of the Science Board
-
October 16, 2019
Sci board
The 33th Meeting of the Science Board
-
October 16, 2019
Sci board
The 32th Meeting of the Science Board
-
October 4, 2019
Pub cmt
JP Drafts (September 30, 2019) posted
-
September 6, 2019
Pub cmt
JP Drafts (September 2, 2019) posted
-
August 5, 2019
JP
The PDG 30th Anniversary Symposium - The History and Future Perspective of PDG - Registration started
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July 24, 2019
Sci board
The 3rd Subcommittee on AMR
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June 7, 2019
Pub cmt
JP Drafts (June, 2019) posted
-
June 3, 2019
Sci board
The 4th Subcommittee on Genome Editing
-
April 23, 2019
RS
Regulatory Science Research in PMDA updated
-
March 5, 2019
Sci board
The 3rd Subcommittee on Genome Editing
-
January 30, 2019
Sci board
The 31th Meeting of the Science Board
-
January 9, 2019
Sci board
The 2nd Subcommittee on Genome Editing
-
November 22, 2018
Sci board
The 1st Subcommittee on Genome Editing
-
October 19, 2018
Sci board
The 2nd Subcommittee on AMR
-
October 3, 2018
Sci board
The 1st Subcommittee on AMR
-
September 26, 2018
Sci board
The 30th Meeting of the Science Board
-
September 7, 2018
Pub cmt
JP Drafts (September, 2018) posted
-
July 17, 2018
Sci board
The 29th Meeting of the Science Board
-
July 13, 2018
Sci board
The 28th Meeting of the Science Board
-
July 13, 2018
Sci board
The 27th Meeting of the Science Board
-
June 7, 2018
Pub cmt
JP Drafts (June, 2018) posted
-
April 3, 2018
RS
"PMDA Views on Applying Continuous Manufacturing to Pharmaceutical Products for Industry (provisional draft)" posted
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March 7, 2018
Pub cmt
JP Drafts (March, 2018) posted
-
December 7, 2017
Pub cmt
JP Drafts (December, 2017) posted
-
September 7, 2017
Pub cmt
JP Drafts (September, 2017) posted
-
June 7, 2017
Pub cmt
JP Drafts (June, 2017) posted
-
January 23, 2017
RS
ICH Q12 WG
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January 4, 2017
JP
Information about Columns for JP draft monographs (Crude drug) posted
-
October 11, 2016
JP
Report of the Japanese Pharmacopoeia 130th Anniversary Symposium (Held on September 15, 2016)
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September 7, 2016
Pub cmt
JP Drafts (September, 2016) posted
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June 8, 2016
Pub cmt
JP Drafts (June, 2016) posted
-
March 31, 2016
Standard
The website of standards for Medical Devices is revised based on PMD act
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March 7, 2016
JP
JP Drafts (March, 2016) posted
-
December 7, 2015
JP
JP Drafts (December, 2015) posted
-
September 24, 2015
Sci board
The 5th Meeting of the Subcommittee on Placebo-controlled Studies
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September 7, 2015
JP
JP Drafts (September, 2015) posted
-
July 17, 2015
Sci board
The 4th Meeting of the Subcommittee on Evaluation of Medical Devices in Pediatric Use
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June 5, 2015
JP
JP Drafts (June, 2015) posted
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May 22, 2015
Sci board
The 5th Subcommittee on Non-clinical Studies
-
May 22, 2015
Sci board
The 6th CPC (Cell Processing Center) Subcommittee Meeting
-
May 21, 2015
Sci board
The 4th Meeting of the Subcommittee on Placebo-controlled Studies
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March 10, 2015
Sci board
The 3rd Meeting of the Subcommittee on Placebo-controlled Studies
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