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《Guideline on Management of Computerized Systems for Marketing Authorization Hold》.pdf
Tentative translation (as of August 17, 2011)
This English version of the Japanese guideline is provided for reference purposes only.
In the event of any inconsistency between the Japanese original and the English
translation, the Japanese text shall prevail.
This is a tentative translation in English which was translated by CSV study group,
is not formally authorized by Ministry of Health, Labour and Welfare of Japan.
PFSB/CND (Yakushoku-kanma) Notification No. 1021-11
October 21, 2010
To: Directors of Health Departments (Bureaus),
Prefectural Governments
From: Director of Compliance and Narcotics Division,
Pharmaceutical and Food Safety Bureau,
Ministry of Health, Labour and Welfare
Guideline on Management of Computerized Systems for Marketing Authorization
Holders and Manufacturers of Drugs and Quasi-drugs
1. General Principles
1.1 Purpose
The purpose of this guideline is, as a revised version of the “Guideline on Control of
Computerized Systems in Drug Manufacturing” (PFSB/CND Notification No. 11 dated
February 21, 1992, revoked by the CND Notification No. 0330001 dated March 30,
2005), to ensure proper enforcement of the “Standards for Quality Assurance for Drugs,
Quasi-drugs, Cosmetics and Medical Devices” (MHLW Ministerial Ordinance No. 136,
established as of September 24, 2004; hereinafter referred to as “GQP Ministerial
Ordinance”) and the “Standards for Manufacturing Control and Quality Control for
Drugs and Quasi-drugs” (MHLW Ministerial Ordinance No. 179, revised as of December
24, 2004; hereinafter referred to as “GMP Ministerial Ordinance”) by:
a) clarifying the requirements on computerized systems that are used by marketing
authorizati
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