WORLD TRADE
ORGANIZATIONG/TBT/Notif.00/351
8 August 2000
(00-3244)
Committee on Technical Barriers to Trade
NOTIFICATION
The following notification is being circulated in accordance with Article 10.6.
1. Member to Agreement notifying:   JAPAN
If applicable, name of local government involved (Articles 3.2 and 7.2):           
2. Agency responsible:   Ministry of Health and Welfare
Agency or authority designated to handle comments regarding the notification shall be
indicated if different from above:           
3. Notified under Article 2.9.2 [     ], 2.10.1 [    ], 5.6.2 [X], 5.7.1 [    ], other:           
4. Products covered (HS or CCCN where applicable, otherwise national tariff heading.
ICS numbers may be provided in addition, where applicable):   Pharmaceuticals
(HS 30.01, 30.02, 30.03, 30.04, 30.05, 30.06)
5. Title, number of pages and language(s) of the notified document:   Revision of
Pharmaceuticals' Post-Marketing Safety Measures (5 pages, available in Japanese)
6. Description of content:   To introduce "Early Post-Marketing Phase Vigilance for New
Drug" (EPPV) and Reconsider the Post-Marketing Study Requirements for Re-examination
Application
7. Objective and rationale, including the na ture of urgent problems where applicable:
Further safety assurance of new drugs at the early phase of post-marketing.
8. Relevant documents:
1. Pharmaceutical Affairs Law (Law No. 145 issued in 1960)
2. Good Post-Marketing Surveillance Practice (MHW Notification No. 10 issued in 
1997)
3. The post-marketing study guideline (MHW  PAB/SD Notification No. 34 issued on 
27 March 1997)
9. Proposed date of adoption:  31 December 2000
Proposed date of entry into force:  1 July 2001
10. Final date for comments:   13 October 2000
11. Texts available from:  National enquiry point [ X] or address, e-mail and telefax
number of the other body:
Safety Division
Pharmaceutical and Medical Safety Bureau
Ministry of Health and Welfare
Kasumigaseki 1-2-2, Chiyoda-kuTokyo 100-8045 Japan
Tel: +81-3-3503-1711 (Ext. 2750)
Fax: +81-3-3508-4364