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) |
|
<AM Session> Moderator: UEDA Mami (PMDA) |
|
|
11:40 - 12:00 |
Report on ICH Inchon Meeting |
|
12:00 - 13:00 |
Panel discussion: China-Japan Cooperation in ICH Chairs: NAKASHIMA Nobumasa (PMDA) Panelists: YASUDA Naoyuki (MHLW) |
|
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) |
|
14:55 - 15:45 |
Topic 2: Real World Data Updates on PEpiDG and related activities in PMDA：UYAMA Yoshiaki(PMDA) |
|
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) |
|
16:50 - 17:40 |
Topic 4: Cell Therapy and Regenerative Medicines Updates on ICH S topics：HIRATA Masakazu, NISHIMURA Jihei (PMDA) |
|
17:40 - 18:00 |
Closing remarks EHARA Teruyoshi (MHLW/PMDA) |