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Innovative Manufacturing Technology WG (IMT-WG)


As QbD (Quality by Design*)-based approaches are being widely adopted in pharmaceutical development, manufacturing and control, emerging technologies are being increasingly introduced into pharmaceutical manufacturing.
The purpose of this WG is to discuss regulatory issues related to quality assessment and GMP inspection to facilitate the introduction of innovative manufacturing technologies while ensuring appropriate quality.
Continuous manufacturing is our primary target.

* Quality by Design; A systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management.


July, 2016


Office of New Drug I-V (Quality)
Office of Cellular and Tissue-based Products
Office of Generic Drugs
Office of Manufacturing/Quality and Compliance
Office of Research Promotion


PMDA Views on Applying Continuous Manufacturing to Pharmaceutical Products for Industry (provisional draft) (Mar. 30, 2018)


Past Presentations

Date Presentation Title Place
Nov. 2022 Development of continuous manufacturing process (Q13) NIFDS-DIA Conference 2022,  Seoul, Korea
Sep. 2022 PMDA perspective on Continuous Manufacturing DIA-USFDA-PMDA-TGA-CDSCO Advanced Manufacturing Workshop, Mumbai, India (Web)
Aug. 2022 Continuous manufacturing experiences from regulatory perspectives in Japan NMPA Training on Continuous Manufacturing, Beijing, China(Web)
Jun. 2021 PMDA/JP Perspective on Continuous Manufacturing Joint MHLW/PMDA-USP Workshop “Role of Quality in Pharmaceuticals”, Tokyo (Web)
Dec. 2020 Update on ICH Q13 ISPE Singapore Affiliate Conference and Exhibition 2020, Singapore (Web)
Apr. 2019 PMDA Perspective The 4th FDA/PQRI Conference on Advancing Products Quality, Rockville, USA
Dec. 2018 The Landscape of Continuous Manufacturing in Japan CMC Strategy Forum Japan 2018,Tokyo
Nov. 2018 Current Regulatory Considerations and Challenges for Continuous Manufacturing of Pharmaceuticals 15th DIA Japan Annual Meeting 2018,Tokyo
Oct. 2018 PMDA Update 3rd International Symposium on Continuous Manufacturing of Pharmaceuticals, London, UK
Jun. 2018 PMDA Activities for Implementation of Continuous Manufacturing 2018 ISPE Continuous Manufacturing Workshop, Arlington, USA
May. 2018 The landscape of continuous manufacturing in Japan 2018 Annual Meeting ISPE Japan Affiliate,Tokyo,Japan
Mar. 2018 Current Regulatory Considerations for Continuous Manufacturing of Pharmaceuticals in Japan 2018 PDA Annual Meeting, Orlando, USA
Feb. 2018 CM Research Outcomes IFPAC 2018, Bethesda, USA
May. 2017 PMDA’s Perspectives on Continuous Manufacturing 2017 Annual Meeting 15th Anniversary ISPE Japan Affiliate, Toyama, Japan
Apr. 2017 PMDA Update DIA CMC Workshop, Rockville, USA
Mar. 2017 PMDA’s Perspectives on Continuous Manufacturing 3rd PQRI/FDA Conference on Advancing Product Quality, Rockville, USA
Nov. 2016 PMDA Perspective on Continuous Manufacturing 13th Annual Meeting, DIA Japan 2016, Tokyo, Japan
Sep. 2016 Continuous Manufacturing
PMDA's Perspective
2nd International Symposium on Continuous Manufacturing of Pharmaceuticals, Cambridge, USA



Date Title Journal Title
Mar. 2021 Control strategy and methods for continuous direct compression processes Asian J Pharm Sci. 16 (2):253-262, 2021
Feb. 2021 Approach to Establishment of Control Strategy for Oral Solid Dosage
Forms Using Continuous Manufacturing
Chem Pharm Bull. 69 (2):211-217, 2021


JCN 3010005007409

Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki,
Chiyoda-ku, Tokyo 100-0013 Japan

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Innovative Manufacturing Technology WG (IMT-WG)