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1st Malaysia-Japan Symposium


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.



Pharmaceuticals and Medical Devices Agency (PMDA) , Japan

National Pharmaceutical Control Bureau (NPCB), Malaysia



Japan Pharmaceutical Manufacturers Association (JPMA)

Malaysian Pharmaceutical Society (MPS)



March 10th and 11th (AM) , 2015




No 5, Jalan Stesen Sentral,
50470 Kuala Lumpur,

Phone: +60 3 2723 1188
Fax: +60 3 2723 1588


150 attendees



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Registration Fee

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Payment Method of Registration Fee

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The Secretariat:
1st 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 :


Simultaneous translation to be provided for Japanese and English


As below:
1st Malaysia - Japan Symposium on Pharmaceutical Regulatory System


Day 1 (10 March 2015)
8:30-9:00 Registration of Participants
Symposium Narration: Ms. Syuhadah Mohamed Hassan, NPCB
9:00-10:00 Updates / Keynote
> "An Overview"
   Mdm. Siti Aida Abdullah, Deputy Director, Centre for Organisational Development, NPCB
> "Role and Vision of PMDA -Promoting Global Public Health-"
   Dr. Taisuke Hojo, Senior Executive Director, PMDA 
Photo Session
10:00-10:30 Morning Break
10:30-12:30 Session 1: Regulatory Review & Updates
Chair: Mdm. Anis Talib, Deputy Director Centre for Product Registration, NPCB
> "Japan regulatory system for pharmaceutical products and Active
   Pharmaceutical Ingredients" 
   Dr. Hiroaki Yamada, Office Director, Office of New Drug II, PMDA
> "Malaysia Regulatory System for Pharmaceutical Products" 
   Mdm. Rosilawati Ahmad, Senior Principal Assistant Director, Centre for Product Registration, NPCB
12:30-14:00 Lunch
14:00-16:00 Session 2: Guidelines & References
Chair: Mr. Teruyoshi Ehara, Office Director, Office of Int'l Programs, PMDA
> "Halal Pharmaceuticals - Regulatory Perspectives" 
   Dr. Tajuddin Akasah, Deuputy DIrector, Centre for Quality Control, NPCB
> "Malaysia Herbal Monograph" 
   Mdm. Mazli Muhammad, Senior Principal Assistant Director, Centre for Quality Control, NPCB
> "Japanese Pharmacopoeia(JP) - Present and Future" 
   Seiko Miyazaki, Office Director, Office of Standards and Guidelines Development, PMDA
16:00-17:30 Afternoon Break & Networking Session
End of Day 1

Day 2 (11 March 2015)
9:00-10:15 Session 3: NPCB Sessions
Chair: Ms. Sameerah binti Shaik Abdul Rahman, Deputy Director, Centre for Post-Registration of Products, NPCB
> "Regulatory Control for Herbal/traditional Medicines and Health
   Supplement Products in Malaysia" 

   Datin Shantini a/p Thevendran, Senior Principal Assistant Director, Centre for Product Registration, NPCB
> "Regulatory Control of Generic Medicines in Malaysia" 
    Ms. Khirul Falisa Nustafa, Principal Assistant Director, Centre for Product Registration, NPCB
10:15-10:45 Morning Break
10:45-12:00 Session 4: PMDA Sessions
Chair: Mr. Daisuke Koga, Deputy Director for Medical Devices, Office of Int'l Programs, PMDA
> "Risk Based Approaches in the Japan-GMP Regulation"
   Dr. Kentaro Hara, Principal Inspector, Office of Manufacturing/Quality and
   Compliance, PMDA
> "Regulatory Framework for Biotherapeutic Products Including Similar
   Biotherapeutic Products"

   Dr. Yasuhiro Kishioka, Principal Reviewer, Office of Cellular and Tissue-based
   Products PMDA
12:00-12:30 Closing Remarks
> Mr. Teruyoshi Ehara, Office Director, Office of Int'l Programs, PMDA
End of Symposium
12:30-14:00 Lunch

JCN 3010005007409

Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki,
Chiyoda-ku, Tokyo 100-0013 Japan

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