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概要

• 論文の詳細を見る

• On Nov. 9, 1988, the Ministry of Health and Welfare (MHW) published the draft for Good Post-Marketing Surveillance Practice (GPMSP: standard for implementation of the post marketing surveillance (PMS) for the reexamination application of new drug) based on the investigation on the pharmaceutical companies' PMS practice for the reexamination application of new drugs in Jul. 1988. During a period from Dec. 1989 to Jan. 1990 the MHW repeated investigation on the PMS practice of pharmaceutical companies in order to know the extent to which pharmaceutical companies met the requirements provided by the draft GPMSP.This report explains and analyzes the result of present investigation and compares them with those of the previous investigation. Both investigations were conducted by sending questionnaire in advance to pharmaceutical companies (130 at this investigation and 127 at previous one) that hold approvals of new drugs which are subject to the reexamination, or to those who are entrusted the PMS for the reexamination by the pharmaceutical companies. Interviews with the persons in charge of the PMS for the reexamination were performed using questionnaire by MHW.The extent to which pharmaceutical companies met the requirements provided in the draft GPMSP was generally increased and in several items the extent was significantly increased. The public announcement of the draft might bring about these improvements.

• 一般社団法人 日本臨床薬理学会の論文

著者

• 林 憲一

  厚生省薬務局企画課

• 高橋 克巳

  厚生省薬務局安全課

• 白神 誠

  厚生省薬務局安全課

• 桜井 祐人

  厚生省薬務局安全課

• 小団扇 浩

  厚生省薬務局安全課

• 森賀 三恵

  厚生省薬務局安全課

• 海老原 格

  厚生省薬務局安全課

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• How to proceed post marketing investigation (phase IV study) in development of drugs. 1 From the standpoint of administration.

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