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第 1 回日本-マレーシアシンポジウム
1 Malaysia - Japan Symposium on Pharmaceutical Regulatory System
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要旨：
医薬品の開発・製造・流通・販売はグローバル化が進んでおり、各国の薬事規制当局及び業界は協力・
連携して規制活動に取り組むことが重要となっております。とりわけ近年、医薬品の臨床開発・製造
の現場としてアジアは重要な地域であり、MHLW／PMDA ではアジア各国の規制当局等との協力関係
の構築に向けた取り組みを強化しております。
本シンポジウムは、医薬品医療機器総合機構（PMDA）とマレーシア国保健省薬品管理局（NPCB）
が主催となり日本・マレーシア間で初めて開催されるシンポジウムであり、両国の薬事の相互理解を
深め、医薬品規制や開発のよりよき発展を目指す事を目的としております。今回のシンポジウムでは、
医薬品の薬事規制の視点から分野別テーマについて掘り下げた発表および討論が行われます。
Purpose:
Globalization of development, manufacturing, trade, and marketing of drugs has been progressing, and
cooperation of regulatory activities amongst pharmaceutical regulatory agencies of each region has
become a necessity. Nowadays, Asian countries have become crucial in clinical development and
manufacturing of drugs globally, and therefore, collaborative relationships among the Asian regulatory
agencies are highly important.
This is the first joint conference being hosted by National Pharmaceutical Control Bureau (NPCB) and
Pharmaceutical and Medical Devices Agency (PMDA), with the aim to enhance Malaysia and Japan’s
mutual understanding of each other’s regulatory system, and to promote advancement of
pharmaceutical regulations and development. This symposium will offer in-depth presentations and
discussions in each area from the pharmaceutical regulatory perspective.
主催 (Host)

独立行政法人医薬品医療機器総合機構
Pharmaceuticals and Medical Devices Agency（PMDA）,
Japan

マレーシア国保健省薬品管理局
National Pharmaceutical Control Bureau (NPCB), Malaysia
後援 (Support)：

日本製薬工業協会 Japan Pharmaceutical Manufacturers Association（JPMA）

マレーシア業界 Malaysian Pharmaceutical Society (MPS)
1．日程 (Date)
平成 27 年 3 月 10 日～11 日（AM）（March 10th and 11th （AM）、2015）
2．会場 (Venue)
ALOFT KUALA LUMPUR SENTRAL
No 5, Jalan Stesen Sentral,
50470 Kuala Lumpur,
Malaysia.
Phone: +60 3 2723 1188
Fax: +60 3 2723 1588
www.aloftkualalumpursentral.com
3．参加者数 (Attendees)
約 150 名 (150 attendees)
Registration will be closed when application reaches 150
4. 参加登録
（Registration）
(1) 参加登録をされる際は、以下の URL より登録フォームへ記入の上、ご送付ください。
To attend the symposium, kindly download the registration form which can be obtained from URL link:
http://portal.bpfk.gov.my/view_file.cfm?fileid=2635
(2) 記入済みの登録フォームと参加費のお支払いのレシートは [email protected] までお送り
ください。
The completed registration forms as well as proof of payment / bank-in receipt must be sent via e-mail
to [email protected]
5．参加費
to confirm your registration.
（Registration Fee）
600 リンギット
(RM 600 / person)
6．参加費のお支払い方法
（Payment Method of Registration Fee）
※４の登録フォーム内に詳細の記載がありますので、そちらをご参照ください。
＊ Please refer to the Registration form in item 4 for details on payment methods.
お支払いに関するご質問につきましては、以下へご連絡ください
（For enquiries on fee payment, kindly contact the following）：
Malaysian Pharmaceutical Society (MPS), Wisma MPS, 16-2, Jalan OP 1/5, 1-Puchong
Business Park, Off Jalan Puchong, 47160 Puchong, Selangor, Malaysia.
Phone: +60-3-8079 1861
Fax: +60-3-8070 0388
E-mail: [email protected]
7．宿泊
(Accommodation)
参加費に宿泊費は含まれません。シンポジウム会場が Aloft Kuala Lumpur Sentral となっております。便
宜を考慮し、会場で宿泊される参加者の方はホテルへ直接ご連絡ください。
The registration fee does not include accommodation.
As the event will be held at Aloft Kuala Lumpur Sentral, participants may wish to choose accommodation
at this hotel for convenience. Please contact the hotel directly for Hotel Reservation
 ALOFT KUALA LUMPUR SENTRAL
https://www.starwoodmeeting.com/StarGroupsWeb/res?id=1501050145&key=18A5C5A1
他のオプション
OTHER OPTIONS:
Participants may also choose accommodation at various nearby hotels that are within walking
distance, some of which are listed below. Kindly contact the chosen hotel directly for Hotel Reservation.
 HILTON KUALA LUMPUR
3 Jalan Stesen Sentral,
50470 Kuala Lumpur,
Malaysia.
Phone: (603) 2264 2264
Fax: (603) 2264 2266
http://www3.hilton.com/en/hotels/malaysia/hilton-kuala-lumpur-KULHIHI/index.html
 LE MERIDIEN KUALA LUMPUR
2 Jalan Stesen Sentral,
Kuala Lumpur Sentral,
50470 Kuala Lumpur,
Malaysia.
Phone: (603) 2263 7888
Fax: (603) 2263 7222
www.lemeridienkualalumpur.com
8．お問い合わせ先
事務局
1st
（Inquiries）
The Secretariat:
Malaysia – Japan Symposium on Pharmaceutical Regulatory System
(Attn: Ms. Sha Yee Vonne)
c/o Centre for Organisational Development
National Pharmaceutical Control Bureau (NPCB),
Ministry of Health Malaysia,
Lot 36, Jalan Universiti,
46200 Petaling Jaya, Selangor.
Phone
: (603) 7801 8489
Fax
: (603) 7958 2960
E-mail
: [email protected]
9．通訳
同時通訳
（Translation）
日本語⇔英語
10．プログラム案
(Simultaneous translation to be provided for Japanese and English)
（Tentative Programme）
As below:
1st Malaysia – Japan Symposium on
Pharmaceutical Regulatory System
Day 1 (10 March 2015)
8:30-9:00
9:00-10:00
Registration of Participants
Symposium Narration: (NPCB)
Welcoming Remarks/Officiating Speech
 YBhg. Dato' Eisah A. Rahman
Senior Director of Pharmaceutical Services, Ministry of
Health, Malaysia (20 min)
Day 1 (10 March 2015)
Updates/Keynote
 NPCB
 “Role and Vision of PMDA -Promoting Global Public
Health-“
Taisuke Hojo, Senior Executive Director, PMDA
(20 min)
PHOTO SESSION (10 min)
10:00-10:30
Morning Break
Session 1: Regulatory Review & Updates
Chair: (NPCB)
10:30-12:30
 “Japan regulatory system for pharmaceutical products
and Active Pharmaceutical Ingredients “(tentative)
Hiroaki Yamada, Office Director, Office of New
Drug II, PMDA
 “Malaysia regulatory system for pharmaceutical
products” (NPCB)
Discussion
12:30-14:00
Lunch
Session 2: Guidelines & References
Chair: (PMDA)
 “MS 2424:2012 - Halal pharmaceuticals: General
guidelines” (NPCB)
14:00-16:00
 “Malaysia herbal monograph” (NPCB)
 “Japanese Pharmacopoeia” (tentative)
Seiko Miyazaki,
Office Director, Office of
Standards and Guidelines Development, PMDA
Discussion
Day 1 (10 March 2015)
16:00-17:30
Afternoon Break & Networking Session
End of Day 1
Day 2 (11 March 2015)
Session 3: NPCB Sessions
Chair: (NPCB)
9:00-10:15
 “Regulatory control for herbal/traditional medicines and
health supplements” (NPCB)
 “Regulatory control for generics” (NPCB)
Discussion
10:15-10:45
Morning Break
Session 4: PMDA Sessions
Chair: (PMDA)
 “GMP Inspection (Risk Based Assessment & Product
Recall)” (tentative)
Kentaro Hara, Principal Inspector, Office of
Manufacturing/Quality and Compliance, PMDA
10:45-12:00
 “Regulatory framework for biotherapeutic products
including similar biotherapeutic products”
Yasuhiro Kishioka, Principal Reviewer, Office of
Cellular and Tissue-based Products PMDA
Discussion
Day 2 (11 March 2015)
Closing Remarks
12:00-12:30
 Teruyoshi Ehara, Office Director, Office of Int’l
Programs, PMDA
End of Symposium
12:30-14:00
Lunch