. /.WORLD TRADE
ORGANIZATIONG/TBT/N/JPN/102
14 November 2003
(03-6115)
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 of the
Enforcement Cabinet Order and Ordinance, and enactment of Notifications for
implementing the revised Pharmaceutical Affairs Law and the Blood Collection and
Donation Arrangement Control Law (9 pages, available in English).
6. Description of content:   The background and summary are as follows.
(1) To amend the Enforcement Cabinet order and Ordinance, and enact Notifications
for implementation of the parts of the revised Pharmaceutical Affairs Law (issued
in July 2002).
(2) Summary
• With regard to safety measures of medical devices, the necessary measures are to be
taken, for example, enacting the general requirements for medical devices(including in vitro  diagnostics devices) and the conformity certification standards
under the third party certification system, classifying medical devices (including
in vitro  diagnostic devices ) according to risk, and designating the medical devices
(including in vitro  diagnostic devices ) which are applied to the conformity
certification.
• With regard to the post-marketing safety measures and the approval and license
system, the necessary measures are to be taken to enact the standards for thepost-marketing safety control (GVP) and the standards for quality control (GQP)
as requirements for obtaining license of manufacturing and marketing, and to revise
the standards for manufacturing and quality control of drugs, etc. (GMP).G/TBT/N/JPN/102
Page 2
• To enforce the Revised Pharmaceutical Affairs Law smoothly, the other measures
are to be taken including designating "the prescription drugs", which need
prescriptions from doctors to sell, enacting the standards for conducting the
non-clinical trials regarding medical device safety (GLP for medical devices ) and
the standards for conducting clinical trials regarding medical devices (GCP for
medical devices ), setting labelling requirements for pharmaceutical products and
materials.
7. Objective and rationale, including the na ture of urgent problems where applicable:
Development of the new advanced medical devices has recently been promoted
corresponding to the advancement of science and technology, and securing the safety of
these devices is necessary according to the characteristics and risks of the medical devices
to the human body. Moreover, it is needed to revise the current approval and license
systems for drugs, medical devices and others taking into account business activities such as
internationalisation or separation of companies, and to promote the efficiency and focussing
of examination for approval.
8. Relevant documents:   The Pharmaceutical Affairs Law and the Law to Secure Stable
Supply of Safe Blood Products. The Enforcement Cabinet Order and Ordinance, and
Notifications will appear in "KAMPO" (Official Government Gazette) when adopted.
9. Proposed date of adoption:  To be determined
Proposed date of entry into force:  1 April 2005
10. Final date for comments:   14 December 2003
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: