Pmda - Pharmaceuticals and Medical Devices Agency

Regulatory Science/The Science Board/Standard Development

Innovative Manufacturing Technology WG (IMT-WG)


As QbD (Quality by Design(Note))-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.

(Note) 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 to V (Quality)
Office of Cellular and Tissue-based Products
Office of Vaccines and Blood Products
Office of Generic Drugs
Office of Manufacturing Quality for Drugs
Office of Review Management
Office of Regulatory Science Coordination



Past Presentations (Last 5 years)

The 4th Symposium of the International Consortium for Advanced Medicines Manufacturing, Cambridge, USA , April 2023


NIFDS-DIA Conference 2022, Seoul, Korea, November 2022


DIA-USFDA-PMDA-TGA-CDSCO Advanced Manufacturing Workshop, Mumbai, India (Web), September 2022


NMPA Training on Continuous Manufacturing, Beijing, China(Web), August 2022


Joint MHLW/PMDA-USP Workshop “Role of Quality in Pharmaceuticals”, Tokyo (Web), June 2021


ISPE Singapore Affiliate Conference and Exhibition 2020, Singapore (Web), December 2020


The 4th FDA/PQRI Conference on Advancing Products Quality, Rockville, USA, April 2019


  • Control strategy and methods for continuous direct compression processes

Asian J Pharm Sci. 16 (2):253-262, 2021

  • Approach to Establishment of Control Strategy for Oral Solid Dosage Forms Using Continuous Manufacturing

Chem Pharm Bull. 69 (2):211-217, 2021