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Events and Symposia

2nd Joint Conference of Taiwan and Japan on Medical Products Regulation

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  1. Date
  2. Venue
  3. Number of Participants
  4. Registration and inquiries
  5. Registration Fee
  6. Interpretation
  7. Agenda


Purpose:

 Globalization of development, manufacturing, trade, and marketing of pharmaceutical 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 significant in clinical development and manufacturing of drugs globally, and therefore, the collaborative relationship among the Asian regulatory agencies are becomes highly important. This symposium is the joint conference being hosted by Taipei Economic and Cultural Representative Office and Interchange Association, Japan, with the aim to enhance mutual understandings, and to construct a basis in a cooperative system across the region for further development in pharmaceutical regulations and health insurance system under the MOU of 5 items signed between Taiwan and Japan on 5th November 2013. As it is the 2nd symposium, the agenda is aiming to deepen the discussion on pharmaceuticals and medical devices from the perspectives of regulation and health insurance system.


Host:

Taipei Economic and Cultural Representative Office
Interchange Association, Japan


Support:

Pharmaceuticals and Medical Devices Agency
Center for Drug Evaluation
Japan Pharmaceutical Manufacturers Association
Japanese Chamber of Commerce & Industry Taipei
International Research-based Pharmaceutical Manufacturers Association
Taiwan Pharmaceutical Manufacturers Association
Taiwan Research-based Pharmaceuticals Manufactures Association
Japan Federation of Medical Devices Associations (JFMDA)
Taiwan Medical and Biotech Industry Association
Taiwan Federation of Medical Device Commercial Associations
Taiwan Generic Pharmaceutical Association
Chinese Pharmaceutical Manufacture and Development Association
Japan Self-Medication Industry (JSMI)
Asia-Pacific Self-Medication Industry (APSMI)
Taiwan Pharmaceutical Marketing & Management Association (TPMMA)

 

Date *The seminar was already held*

31st October, 2014
 

Venue

Keynote lecture (joint program of pharmaceuticals and medical devices) :
Nihonbashi Sunsky room

Address:

4th floor of Sanshin Muromachi bulding,
3-2-8 Nihonbashi-muromachi, Chuo-ku, Tokyo 103-0022

Phone:

03-3516-3481

FAX:

03-3277-2639
 

* After the keynote lecture session, the meeting venue will be separated for "pharmaceuticals" and "medical devices" as follows
 

1) Medical devices

Nihonbashi Sunsky room: same as the keynote lecture session

2) Pharmaceuticals

Japan Pharmaceutical Manufacturers Association

Address:

Torii Nihonbashi,
3-4-1 Nihonbashi-Honcho, Chuo-ku, Tokyo 103-0023

Phone:

03-3241-0326

FAX:

03-3242-1767

Number of the attendees

150 attendees

Registration and inquiries

*Registration Closed*

Please register to attend the conference via below website;


Japanese
https://www.praise-net.jp/pn/m/e.asp?id=NjEzMw  (Currently not available)
English
https://www.praise-net.jp/pn/m/e.asp?id=NjEzNQ  (Currently not available)


Inquiries
 

Japan Pharmaceutical Manufacturers Association
Shibata,
Office of International Programs

Tel:

03-3241-0326

Fax:

03-3242-1767

E-mail:

shibata@jpma.or.jp
 

Japan Federation of Medical Devices Associations (JFMDA)
Tanaka, Naito,
Office of International Programs

Tel:

03-5225-6234

Fax:

03-3260-9092

E-mail:

global@jfmda.gr.jp
 

Registration Fee

Free

* JPY 5000 per person will be charged for the attendees to the welcome receptions

Interpretation

Simultaneous translation to be provided for Japanese and Chinese

Agenda (October 31st)

Pharmaceuticals and Medical devices
08:30-08:40
Opening remarks
08:40-10:00
Keynote lecture (TFDA/NHIA/PMDA and industry input)
 
Pharmaceuticals
Regulation session
11:00-12:30
MRCT and New drug review
Japan:
"Recent experiences to review data from MRCTs and progress of research on ethnic factors"
Dr. Yoshiaki Uyama, Division Director, Division of Epidemiology, Office of Safety I,*PMDA (30min)

Taiwan:
“Clinical Trial Capacity and New Drug Reviews Related to MRCTs in Taiwan”
Dr. Chi-Hsun Chen, Team Leader, Center for Drug Evaluation (30min)

Q&A: 30min
 
14:00-15:00
Regenerative products
Japan:
"Regulatory Reform for Regenerative Medicine in Japan"
Dr. Daisaku Sato, Director, Office of Cellular and Tissue-based Products,* PMDA (20min)

Taiwan:
"Regulation of cell therapy products in Taiwan"
Dr. Yi-Chu Lin, Associate Researcher, Division of Medicinal Products, TFDA (20min)

Q&A: 20min
 
15:00-16:00
Nano technology and products
Japan:
"Evaluation of nanotechnology-based medicines"
Dr. Naomi Nagai, Principal Senior Scientist, Center for Product Evaluation, * PMDA (20min)

Taiwan:
“Regulatory Considerations for Nanotechnology-related Drug Products in Taiwan”
Dr. Lin-Chau Chang, Team Leader, Center for Drug Evaluation (20min)

Q&A: 20min
 
16:30-17:30
OTC
Japan:
"Regulation of OTC Drugs in Japan"
Dr. Takatoshi Nakamura, Director, Office of OTC/Generic Drugs,* PMDA (20min)

Taiwan:
"Introduction of OTC regulations in Taiwan"
Mr. Heng-Jung Lien, Section Chief, Division of Medicinal Products, TFDA (20min)

Q&A: 20min
 
17:30-17:45
Closing and summary
   
Medical devices
11:00-11:50
Overall topics (PMS, GCP, Registration, QSD/QMS)
PMS (Taiwan)
 "Report on Collaborative Activities Related to Medical Device Post Market Surveillance (PMS) System"
 Ms. Yu-Wen Huang, TFDA (10min)

 GCP (Japan)
 "GCP WG Activity Report"
 Mr. Hideyuki Kondo, MHLW (10min)

 Product Registration (Taiwan)
 "Progress of Product Registration Working Group"
 Mr. Ta-Jen Wu, TFDA (15min)

 QSD/QMS (Japan)
 "Report on collaborative activities related to QSD/QMS"
 Mr. Hideki Asai, (15min)
 
12:00-12:30
Q&A and wrap-up
 
Health Insurance session
14:20-14:30
Opening remarks
Japan:
Mr. Katsufumi Jo, Director, Economic affairs division Health policy Bureau

Taiwan:
Dr. San Kuei Huang, Director- General, NHIA
 
14:30-15:30
Access to New drugs 1
Japan:
"A Measure to Ensure Transparency and Efficiency in Drug Pricing System"
Mr. Shinichi Takae, Deputy Director, Economic affairs, Health policy Bureau, MHLW

Taiwan:
"Efficiency and transparency in pricing"
Mr. Shang-ping Chen, Senior Executive officer NHIA
 
15:50-16:50
Access to New drugs 2
Japan:
"National Health Insurance Pricing formula in Japan"
Mr. Yasuhiro Matsunaga, Japan Pharmaceutical Manufacture Association

Taiwan:
"Policy for reimbursing orphan drugs"
Mr. Shang-ping Chen, Senior Executive officer, NHIA
 
16:50-17:30
Separation of medical and dispensary practice
"Separation of Dispensing and Prescribing Drugs in Japan"
Mr. Katsuaki Ura, Assistant Director of General Affairs Division, Pharmaceutical and Food Safety Bureau, MHLW
 
17:30-17:45
Closing and summary
Japan:
Mr. Shinichi Takae (MHLW)

Taiwan:
Mr. Shang-ping Chen(NHIA)
 
18:00-
Welcome reception * TKP Otemachi Conference room

2014taiwan_sympo