Pmda - Pharmaceuticals and Medical Devices Agency

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Joint MHLW/PMDA-USP Workshop “Role of Quality in Pharmaceuticals”

This Joint MHLW/PMDA-USP Workshop has ended. Thank you for attending.


 The critical importance of quality for pharmaceutical medicines has never been more evident than it has been as the result of the COVID-19 public health crisis.  Supply chains to bring quality medicines to patients have faced significant challenges, for example, the shutdown of certain manufacturing facilities, disruptions in transportation infrastructure and weaken urgent needs to find alternative sources of medicines.  As a result, traditional approaches to bringing quality medicines to patients have undergone rapid change.  Pharmacopeias, including the United States Pharmacopeia (USP) and the Japanese Pharmacopoeia (JP) have been working together on these critical issues facing medicine quality including setting specifications for wide variety of active pharmaceutical ingredients (APIs), formulations, excipients, and packages, as well as their standard test methods, with the goal to ensure that patients have trust in their medicines.  USP and JP/the Ministry of Health Labour, and Welfare (MHLW)/Pharmaceutical and Medical Devices Agency (PMDA) have a long history of collaboration and cooperation, and have developed an effective working partnership in the contribution to global public health.  As such, USP and MHLW/PMDA would like to promote a workshop on the topic of “Role of Quality in Pharmaceuticals” in East Asia including Japan by introducing our activities to ensure quality of medicines, the role we have played in the response to the current crisis and changes including global COVID-19 pandemic, and what this means for the future of the intersection of pharmacopeias, regulators, and industry in responding to a public health emergency, and how this may change our operations in the future. 

 Potential topics for the workshop include an analysis of supply chain vulnerabilities, and the roles that USP and MHLW/PMDA/JP can play in ensuring resilient supply chain.  In addition, new and emerging areas for USP and MHLW/PMDA/JP collaboration may be explored, including examples such as Impurities Management, qNMR, and Biotechnological standards such as monoclonal antibodies and oligonucleotides.  Furthermore, the workshop will explore ICH Quality Topics that intersect with USP and MHLW/PMDA/JP, specifically in the areas of Pharmaceutical Continuous Manufacturing, Analytical Method Validation, and Impurities (including mutagenic impurities). 

 USP and MHLW/PMDA look forward to your participation in our joint workshop!

Date and Time

JST Jun. 16 - 17, 2021 (EST Jun. 15 - 16, 2021)

Workshop Format

Virtual Meeting

Target Audience

Industry, academia, and regulator from Japan and East Asia. Doctors, medical workers, and patients are hopefully expected.


Organizer: MHLW, PMDA and USP / Facilitator: PDA Japan


English-Japanese Simultaneous Translation Available


 <Day 1: JST June 16>

Time Contents, Speakers
8:30~8:40 Opening Remarks Dr. Hiroyuki Arai, PMDA


Opening Session: Role of Pharmacopeia in the Pandemic Era 
Medicines quality throughout the COVID-19 pandemic: Collaboration and Trust”

Dr. Ronald T Piervincenzi, USP

Session 1: Introduction of each Pharmacopeia
Moderator: Dr. Kevin T Moore, USP
- USP Now and in the Future
- Introduction of the Japanese Pharmacopoeia
- PMDA’s activity against COVID-19
15 min
15 min
 5 min
Mr. Mario Sindaco, USP
Dr. Yukihiro Goda, NIHS
Mr. Kenichi Mikami, PMDA
9:50~10:05 Break
10:05~10:45 Session 1 contd.
- Over Three Decades of Partnering in Public Health: USP-MHLW/PMDA Collaboration
- Expectation from industry
- Q&A

15 min

10 min
15 min

Dr. Kevin T Moore, USP

Dr. Makoto Ono, FPMAJ




Session 2: New Technologies and Modalities
Moderator: Dr. Kenichi Izutsu, NIHS
(1) Continuous manufacturing
- PMDA/JP Perspective on Continuous Manufacturing
- Supporting Continuous Manufacturing: Ongoing USP Initiatives
- Q&A
(2) qNMR
- Implementation of qNMR in the Japanese Pharmacopoeia

20 min

20 min

  5 min

20 min

Dr. Yoshihiro Matsuda, PMDA
Dr. Atul Dubey, USP

Dr. Nahoko Uchiyama, NIHS
11:50~12:50 Lunch Break
12:50~13:15 Session 2 (2) contd.
- Lifecycle Approach to Quantitative NMR Analytical Procedure
- Q&A

20 min
5 min

Dr. Toru Miura, USP
(3) Performance Testing
- New performance tests for formulations in Japanese Pharmacopoeia
- USP updates on Performance Tests

- Q&A

20 min

20 min

5 min

Dr. Hiroyuki Yoshida, NIHS
Dr. Margareth Marques, USP
14:00~14:15 Break
14:15~15:45 Session 3: Standards for Biologics
Moderator: Dr. Akiko Ishii-Watabe, NIHS
- Current trends and future perspectives of JP standards for biologics

-  General Information: Bacterial Endotoxins Test and Alternative Methods using Recombinant Protein-reagents for Endotoxin Assay <G4-4-180>
- Evolving USP Biologics Standards
- Q&A
20 min

20 min

40 min
10 min
Dr. Akiko Ishii-Watabe,
Dr. Hiroko Shibata
Dr. Yutaka Kikuchi, JP (Chiba Prefectural University of Health Sciences)
Dr. Fouad Atouf, USP
15:45~16:00 Break
Session 4: Impurities: Mutagenic impurities and more
Moderator: Mr. Hiromu Toyoda, FPMAJ / Dr. Mrunal A. Jaywant, USP
- ICH M7: Situation at a Japanese Company
- Current approach for control of nitrosamine impurities in Japan
- Control of organic impurities in marketed products in Japan - current status and perspectives
- Control of elemental impurities and current status in Japan
- Control of nitrosamine impurities in sartan drugs
- Q&A
20 min

20 min

20 min

10 min

10 min

10 min
Dr. Kazusei Komatsu, FPMAJ
Mr. Yasuo Hirai, FPMAJ
Dr. Junichi Fukuchi, PMDA

Mr. Shunin Hikage, PMDA
Dr. Masahiro Uchino, PMDA
17:30~17:40 Day 1 closing

 <Day 2: JST June 17>

Time Contents, Speakers
8:30~8:40 Day 2 opening
8:40~9:30 Session 4 contd.
- Nitrosamine Impurities, USP’s Response -Tools & Resources
- General Principles and Approach for Addressing Element-Specific Chapters and Tests in Excipient Monographs
- Q&A

20 min

20 min

10 min

Mr. Naiffer E. Romero, USP
Dr. Catherine Sheehan, USP
9:30~10:30 Panel Discussion for Session 2-4
Moderator: Mr. Kenichi Mikami, PMDA / Dr. Kevin T Moore, USP
10:30~10:40 Break

Key Note Session: Future Perspectives
Moderator: Mr. Shigeki Tsuda, PMRJ
- USP’s Vision for the Advancement of Science Quality as a Framework for Pharmacopeial Collaboration.
- Q&A for USP
- JP’s Future Perspective on collaboration with USP
- Q&A for PMDA/JP 
25 min

10 min
25 min

10 min
Dr. Jaap Venema, USP

Dr. Haruhiro Okuda, PMRJ
11:50~12:00 Closing Remarks  Mr. Masahiro Takahata, MHLW



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