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What's New（Regulatory Science/The Science Board/Standard Development）

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What's New（Regulatory Science/The Science Board/Standard Development）

March 7, 2023 JP Drafts (March 2023) No.1 posted
March 7, 2023 JP Drafts (March 2023) No.2 posted
March 1, 2023 PDG (Pharmacopoeial Discussion Group) Stage 2 Drafts (March, 2023) posted
February 28, 2023 PDG October 2022 Videoconference Meeting Press Release (Sign-offs) posted
February 28, 2023 PDG October 2022 Videoconference Meeting Highlights posted
February 27, 2023 The 44th Science Board Meeting
February 27, 2023 The 4th Subcommittee on Software as a Medical Device Utilizing AI and Machine Learning
February 20, 2023 The 3rd Subcommittee on Software as a Medical Device Utilizing AI and Machine Learning
January 17, 2023 The 45th Science Board Meeting
January 17, 2023 The Science Board has prepared Points to Consider for Gut Bacterial Products Based on Microbiome Research.
January 13, 2023 Recent Publications by PMDA Staffs updated
December 28, 2022 JP 18th Edition Supplement I (Japanese version) posted
December 28, 2022 Schedule of JP18-II Publication posted
December 28, 2022 JP Frequently Asked Questions Q3 updated
December 7, 2022 JP Drafts (December 2022) posted
November 30, 2022 The 2nd Subcommittee on Software as a Medical Device Utilizing AI and Machine Learning
November 15, 2022 The 6th Subcommittee on Therapeutic Products Based on Extracellular Vesicles (EVs) Including Exosomes
September 28, 2022 The 1st Subcommittee on Software as a Medical Device Utilizing AI and Machine Learning
August 22, 2022 The 5th Subcommittee on Therapeutic Products Based on Extracellular Vesicles (EVs) Including Exosomes
August 2, 2022 The 43rd Science Board Meeting
July 20, 2022 Implementation of PDG harmonized texts into Japanese Pharmacopoeia (General Chapters) updated
April 11, 2022 The 4th Subcommittee on Therapeutic Products Based on Extracellular Vesicles (EVs) Including Exosomes
March 30, 2022 The 42nd Science Board Meeting
March 1, 2022 Implementation of PDG harmonized texts into Japanese Pharmacopoeia (Monographs)
March 1, 2022 PDG Harmonization Policy and PDG Working Procedure updated
February 15, 2022 Recent Presentation by PMDA Staffs updated
January 24, 2022 The 41st Science Board Meeting
January 24, 2022 The 3rd Subcommittee on Therapeutic Products Based on Extracellular Vesicles (EVs) Including Exosomes
December 24, 2021 The 40th Science Board Meeting
December 7, 2021 JP Drafts (December 2021) posted
November 8, 2021 JP Drafts (November 2021) posted
November 8, 2021 JP Drafts (September 2021) No.2 updated
November 2, 2021 PMDA Guidance on Patient Participation
October 8, 2021 The 2nd Subcommittee on Therapeutic Products Based on Extracellular Vesicles (EVs) Including Exosomes
October 5, 2021 The 7th Subcommittee on Microbiome
September 7, 2021 JP Drafts (September 2021) No.1 posted
August 13, 2021 The 1st Subcommittee on Therapeutic Products Based on Extracellular Vesicles (EVs) Including Exosomes
August 3, 2021 The 6th Subcommittee on Microbiome
June 7, 2021 JP Drafts (June 2021) No.2 posted
June 7, 2021 JP Drafts (June 2021) No.1 posted
May 19, 2021 Update the page for RWD WG：MHLW notifications on Registry utilization and data reliability
May 19, 2021 The 5th Subcommittee on Microbiome
May 12, 2021 The 39th Science Board Meeting
April 7, 2021 Information on implementation of ICH-Q3D into the Japanese Pharmacopoeia posted
March 31, 2021 The 38th Science Board Meeting
March 12, 2021 The 4th Subcommittee on Microbiome
March 5, 2021 JP Drafts (March 2021) posted
January 27, 2021 The 3rd Subcommittee on Microbiome
January 26, 2021 The 7th Subcommittee on Computer Simulation
November 17, 2020 The 6th Subcommittee on Computer Simulation
November 5, 2020 The 2nd Subcommittee on Microbiome
October 12, 2020 The 5th Subcommittee on Computer Simulation
September 11, 2020 The 37th Science Board Meeting
September 7, 2020 JP Drafts (September 2020) posted
August 24, 2020 The 4th Subcommittee on Computer Simulation
August 18, 2020 The 1st Subcommittee on Microbiome
July 8, 2020 The 3rd Subcommittee on Computer Simulation
June 23, 2020 The 36th Meeting of the Science Board
June 5, 2020 JP Drafts (June 2020) posted
May 14, 2020 JP17 Updated Errata, JP17-1 Errata, and JP17-2 Errata Posted
March 11, 2020 The 2nd Subcommittee on Computer Simulation
March 11, 2020 The 1st Subcommittee on Computer Simulation
March 6, 2020 JP Drafts (March 2020) No.1 posted
March 6, 2020 JP Drafts (March 2020) No.2 posted
February 17, 2020 The 35th Meeting of the Science Board
December 6, 2019 JP Drafts (December 2019) posted
November 8, 2019 JP Drafts (November 2019) posted
November 5, 2019 The 5th Subcommittee on Genome Editing
October 16, 2019 The 34th Meeting of the Science Board
October 16, 2019 The 33th Meeting of the Science Board
October 16, 2019 The 32th Meeting of the Science Board
October 4, 2019 JP Drafts (September 30, 2019) posted
September 6, 2019 JP Drafts (September 2, 2019) posted
August 5, 2019 The PDG 30th Anniversary Symposium - The History and Future Perspective of PDG - Registration started
July 24, 2019 The 3rd Subcommittee on AMR
June 7, 2019 JP Drafts (June, 2019) posted
June 3, 2019 The 4th Subcommittee on Genome Editing
April 23, 2019 Regulatory Science Research in PMDA updated
March 5, 2019 The 3rd Subcommittee on Genome Editing
January 30, 2019 The 31th Meeting of the Science Board
January 9, 2019 The 2nd Subcommittee on Genome Editing
November 22, 2018 The 1st Subcommittee on Genome Editing
October 19, 2018 The 2nd Subcommittee on AMR
October 3, 2018 The 1st Subcommittee on AMR
September 26, 2018 The 30th Meeting of the Science Board
September 7, 2018 JP Drafts (September, 2018) posted
July 17, 2018 The 29th Meeting of the Science Board
July 13, 2018 The 28th Meeting of the Science Board
July 13, 2018 The 27th Meeting of the Science Board
June 7, 2018 JP Drafts (June, 2018) posted
April 3, 2018 "PMDA Views on Applying Continuous Manufacturing to Pharmaceutical Products for Industry (provisional draft)" posted
March 7, 2018 JP Drafts (March, 2018) posted
December 7, 2017 JP Drafts (December, 2017) posted
September 7, 2017 JP Drafts (September, 2017) posted
June 7, 2017 JP Drafts (June, 2017) posted
January 23, 2017 ICH Q12 WG
January 4, 2017 Information about Columns for JP draft monographs (Crude drug) posted
October 11, 2016 Report of the Japanese Pharmacopoeia 130th Anniversary Symposium (Held on September 15, 2016)
September 7, 2016 JP Drafts (September, 2016) posted
June 8, 2016 JP Drafts (June, 2016) posted
March 31, 2016 The website of standards for Medical Devices is revised based on PMD act
March 7, 2016 JP Drafts (March, 2016) posted
December 7, 2015 JP Drafts (December, 2015) posted
September 24, 2015 The 5th Meeting of the Subcommittee on Placebo-controlled Studies
September 7, 2015 JP Drafts (September, 2015) posted
July 17, 2015 The 4th Meeting of the Subcommittee on Evaluation of Medical Devices in Pediatric Use
June 5, 2015 JP Drafts (June, 2015) posted
May 22, 2015 The 6th CPC (Cell Processing Center) Subcommittee Meeting
May 22, 2015 The 5th Subcommittee on Non-clinical Studies
May 21, 2015 The 4th Meeting of the Subcommittee on Placebo-controlled Studies
March 10, 2015 The 3rd Meeting of the Subcommittee on Placebo-controlled Studies

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