Search results with tag "Ministerial ordinance"
Regulation on Clinical Trials in Japan - Pmda
www.pmda.go.jpministerial ordinance (GCP) in order to protect study subjects and ensure data reliability. The studies are conducted as a part of daily medical practice. In addition to mutual trust between patient and doctor, requirement of ethical consideration is stipulated by ministerial announcement. prospective interventional study 7
Tentative translation of MHLW MO 169 Chapter 3, as revised ...
www.pmda.go.jpprovision of this Ministerial Ordinance (hereinafter referred to as the "quality control duties"). (i) To be a responsible person of the Quality Assurance Division in The Marketing Authorization Holder etc. (ii) To be the person who was engaged in the quality control duties or equivalent duties for 3 years or longer
Explanation of Application for Accreditation of Foreign ...
www.pmda.go.jpMinisterial Ordinance etc. of Partial Revision of the Regulations for Manufacturing Control and Quality Control of Drugs and Regulations for Buildings and Facilities for Pharmacies, etc.” (PAB Notification No. 1332, dated October 9, 1980). In addition, they need to submit informative documents for examination of buildings
![Ministerial Ordinance [GMP]](/cache/preview/a/c/3/2/0/4/6/7/thumb-ac3204671116de739299ced890c30835.jpg)
Ministerial Ordinance [GMP]
www.pmda.go.jpTitle: Ministerial Ordinance [GMP] Created Date: 9/13/2005 10:08:18 AM
Ministerial Ordinance to Provide the Technical Standard on ...
www.mlit.go.jp(Guide way Alignment) Article 13. Radius of curve and gradient of the main track shall be able to ensure the high-speed and large capacity performance of the rail transport, taking the