JAPAN: DRUGS, QUASI-DRUGS, COSMETICS AND MEDICAL DEVICES The following notification is being circulated in accordance with Article 10.6. G/TBT/Notif. 95.361. 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. 3. Notified under Article 2.9.2. 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 and medical devices (HS:05, 12, 13, 17, 27, 29, 30, 32-35, 37, 38, 40, 48, 90, 94 and 96). 5. Title and number of pages of the notified document: Amendment to ``The Pharmaceutical Affairs Law'' and ``The Organization for Drug ADR Relief, R&D Promotion and Product Review Law (available in Japanese, 6 pages). 6. Description of content: (1) Improvement of measurements to ensure quality of clinical trials such as trial plans investigation and good clinical practice (GCP). (2) Improvement of examination such as good laboratory practice (GLP)/GCP investigation. (3) Improvement of measurements to ensure quality of post-marketing surveillance (PMS) such as good post-marketing surveillance practice (GPMSP) investigation. 7. Objective and rationale: Improvement of measures to ensure safety of drugs and others. 8. Relevant documents: The basic laws are the Pharmaceutical Affairs Law and the Organization for Drug ADR Relief, R&D Promotion and Product Review Law. The said amendment will appear in ``KAMPO'' (Official Government Gazette) when adopted. 9. Proposed date of adoption and entry into force: 1 April 1997. 10. Final date for comments: 26 February 1996. (025)

Loren Data Corp. http://www.ld.com (SYN# 0507 19960126\FO-0002)