China and Japan Regional Joint Public Meeting on ICH

This Public Meeting has ended. Thank you for attending.

May 21, 2021
Pharmaceuticals and Medical Devices Agency

Introduction

Around four years have passed since China became a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and in the meantime, various efforts have been made to implement ICH guidelines in China.
This timely meeting is intended for sharing what will be discussed at the ICH virtual assembly which is scheduled at the beginning of June, and the implementation status of ICH guidelines in both China and Japan.
Through this meeting, it is expected to deepen our understanding of the situation in each country, to promote implementation of ICH guidelines in both countries, and to work together to meet patient expectations of both countries.

Hosts

Ministry of Health, Labour and Welfare (MHLW)
Pharmaceuticals and Medical Devices Agency (PMDA)
National Medical Products Administration (NMPA)
Japan Pharmaceutical Manufacturers Association (JPMA)

Date and Time

Friday, June 18, 2021, 11:30-18:00 (Japan time)

Seminar Format

This seminar will be held in the online format.

Registration

Registration closed

There is no registration fee for this seminar.
Please register through the following website. (Available only in Japanese)

https://www.praise-net.jp/pn/m/semi/top.asp?seminar_id=MTQ1OQ==&mode=3

Registration can be made until Tuesday, June 15.

Simultaneous Interpretation

Chinese ⇔ Japanese

Program

Time	Content
11:30 - 11:40	Opening remarks NAKASHIMA Nobumasa (PMDA) Sheng Yang (NMPA)
<AM Session> Moderator: UEDA Mami (PMDA)
11:40 - 12:00	Report on ICH Inchon Meeting TANABE Hirooki (MHLW) Siyuan Zhou (NMPA)
12:00 - 13:00	Panel discussion: China-Japan Cooperation in ICH Chairs: NAKASHIMA Nobumasa (PMDA) Siyuan Zhou (NMPA) Panelists: YASUDA Naoyuki (MHLW) EHARA Teruyoshi (PMDA) Ning Zhang (NMPA) Zhimin Yang (NMPA) YOKOTA Masafumi (JPMA) Ling Su (Chinese industry)
13:00 - 14:00	Lunch break
<PM Session 1> Moderator: Siyuan Zhou (NMPA)
14:00 - 14:55	Topic 1: Clinical Trials Updates on ICH E topics：Zhimin Yang(NMPA) Perspectives from Japan：MIYOSHI So (JPMA) Perspectives from China：Haiyan Li (Peking University Third Hospital) Ao Peng (RDPAC) Q&A
14:55 - 15:45	Topic 2: Real World Data Updates on PEpiDG and related activities in PMDA：UYAMA Yoshiaki(PMDA) Perspectives from Japan：SAGAWA Kei (JPMA) Perspectives from China：Jun Wang (NMPA) Chengming Gu (RDPAC) Q&A
15:45 - 16:00	Coffee break
<PM Session 2> Moderator: Siyuan Zhou (NMPA)
16:00 - 16:50	Topic 3: Quality Updates on ICH Q topics：Ning Zhang (NMPA) Perspectives from Japan：NAKAGAWA Tomonori(JPMA) Perspectives from China：Jufang Xu (PhIRDA) Xiaofeng Li (RDPAC) Q&A
16:50 - 17:40	Topic 4: Cell Therapy and Regenerative Medicines Updates on ICH S topics：HIRATA Masakazu, NISHIMURA Jihei (PMDA) Perspectives from Japan：SAKURAI Akira (JPMA) Perspectives from China：Qingli Wang (NMPA) Tian Xu (Westlake University) Q&A
17:40 - 18:00	Closing remarks EHARA Teruyoshi (MHLW/PMDA) Siyuan Zhou (NMPA) MORI Kazuhiko (JPMA) Ling Su (Chinese industry)