. /.WORLD TRADE
ORGANIZATIONG/TBT/N/JPN/35
6 February 2002
(02-0561)
Committee on Technical Barriers to Trade Original:  English
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, Labour and Welfare
Name and address (including telephone and fax numbers, e-mail and web-site
addresses, if available) of  agency or authority designated to handle comments
regarding the notification shall be  indicated if different from above:           
3. Notified under Article 2.9.2 [ X], 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):   Drugs, quasi-drugs,
cosmetics, medical devices and blood products
5. Title, number of pages and language(s) of the notified document:   Amendment to the
Pharmaceutical Affairs Law and the Blood Collection and Donation Arrangement Control
Law (7 pages, in Japanese)
6. Description of content:
1. Amendment to the Pharmaceutical Affairs Law
(1) To introduce human risk classification systems for medical devices regulation, to
introduce legislations on Good Laboratory Prac tices (GLPs) and Good Clinical Practices
(GCPs) for medical devices, and to improve labelling requirements, etc. in order to
reinforce the overall safety measures concerning medical devices.  And to introduce third
party certification systems for lower-risk medical devices.
(2) To clarify the legal scope of "biological products" with a view to establishing
consistent safety assurance framework covering every step from source material collection
and manufacturing to use, under which some measures are introduced such as recordkeeping requirements of source materials of higher-risk biological products and
improvements of labelling requirements.
(3) To restructure the approval system of drugs/medical devices etc. to shift from the
current manufacturing-oriented approval/licence system to the marketing authorization
system with emphasis on post-marketing safety measures.
2. Amendment to the Blood Collection and Donation Arrangement Control LawG/TBT/N/JPN/35
Page 2
(1) To add the improvement of safety and stable supply of blood products to the
purpose of the law.
(2) To establish a basic policy to ensure stable supply of safety blood products
(3) To improve related measures concerning blood collection and donation.
7. Objective and rationale, including the na ture of urgent problems where applicable:
Improvement of measures to ensure safety of drugs, quasi-drugs, cosmetics, medical
devices, and to secure stable supply of safer blood products.
8. Relevant documents:   The basic laws are the Pharmaceutical Affairs Law and the Blood
Collection and Donation Arrangement Control Law.  The said amendment will appear in"KAMPO" (Official Government Gazette) when adopted.
9. Proposed date of adoption:
Proposed date of entry into force: }To be determined
10. Final date for comments:   1 March 2002
11. Texts available from:  National enquiry point [ X] or address, telephone and fax
numbers, e-mail and web-site addresses, if available of the other body:           