日本药典简介

2015-09-16 16:34:16.0

  2006年3月31日,日本厚生劳动省通过部长级会议285号通告发布第15版日本药典(JP)。

  2006年7月,日本药典委员会确立了第16版JP编制的基本原则,阐述了JP的作用和特征、确切的修订措施和修订日期。

日本药典编写原则

  JP委员会确立的JP的5个基本原则(我们称其为“五根支柱”)包括如下方面:1)囊括从健康保健、医学治疗的角度来看,所有被视为重要的药物;2)引入最新科技,从质量上做出改进;3)促进国际化;4)必要时,及时开展部分修订,推进平稳的行政运作;5)确保修订工作的透明度,并且向公众宣传JP。一致认为,JP委员会应该在这些原则的基础上,努力采取适当的措施,包括争取其它关系方的理解和合作,以确保JP更加有效地运用于健康保健和医学治疗领域。

日本药典专家组

  第16版JP(日本版本)的预定发布日期设为2011年4月。组建JP专家委员会,其中包括以下小组委员会:修订原则小组委员会;修订原则分委员会;医用化学品小组委员会;抗生素小组委员会;生物制剂小组委员会;生药小组委员会;药用辅料小组委员会;物理化学方法小组委员会;制剂小组委员会;物理方法小组委员会;生物学检验小组委员会;命名法小组委员会;国际协调小组委员会;制药用水小组委员会;参考标准小组委员会。此外,在物理化学方法小组委员会、制剂小组委员会和生物学检验小组委员会下面设立工作组,以加快对修订草案的讨论。

修订频率

  除了每5年1次遵循JP编制基本原则开展常规修订外,一致认为可以在必要时开展部分修订,以便顾及最近的科学进展和符合国际协调。

16版日本药典包含基本内容

  由于此次修订,第16版JP包括了1764种物品,其中增加了106种物品,并且删除了15种物品。

相关信息

1. 本药典的官方名称为“第十六改正日本薬局方”,缩写为“日局十六、日局16、JP XVI或JP 16”。

2. 本药典的英文名称为“The Japanese Pharmacopoeia, Sixteenth Edition”。


About JP

2015-09-16 16:30:16.0

The 15th Edition of the Japanese Pharmacopoeia (JP) was promulgated by Ministerial Notification No.

285 of the Ministry of Health, Labour and Welfare (MHLW) on March 31, 2006.

In July 2006, the Committee on JP established the basic principles for the preparation of the JP 16th Edition, setting out the roles and characteristics of the JP,the definite measures for the revision, and the date of the revision.

Principles of JP

At the Committee, the five basic principles of JP, which we refer to as the ``five pillars'', were estab-

lished as follows: 1) Including all drugs which are important from the viewpoint of health care and medical treatment; 2) Making qualitative improvement by introducing the latest science and technology; 3) Promoting internationalization; 4) Making prompt partial revision as necessary and facilitating smooth administrative operation; and 5) Ensuring transparency regarding the revision, and disseminating the JP to the public. It was agreed that the Committee on JP should make efforts, on the basis of these principles, to ensure that the JP is used more effectively in the fields of health care and medical treatment by taking appropriate measurements, including getting the understanding and cooperation of other parties concerned.

JP Expert Committees

The target date for the publication of JP 16th Edition (the Japanese edition) was set as April 2011.

JP Expert Committees are organized with the following panels: Panel on the Principles of Revisions;

Sub-committee on the Principles of Revisions; Panel on Medicinal Chemicals; Panel on Antibiotics; Panel on Biologicals; Panel on Crude Drugs; Panel on Pharmaceutical Excipients; Panel on Physico-Chemical Methods; Panel on Preparations; Panel on Physical Methods; Panel on Biological Tests; Panel on Nomenclature; Panel on International Harmonization; Panel on Pharmaceutical Water; and Panel on Reference Standards. Furthermore, working groups are established under the Panel on Physico-Chemical Methods, Panel on Preparations and Panel on Biological Tests to expedite discussion on revision drafts.

Revision Frequency

In addition to the regular revision every five years in line with the basic principles for the preparation of the JP it was agreed that partial revision should be done as necessary to take account of recent progress of science and in the interests of international harmonization.

Content of the JP 16th Edition

In consequence of this revision, the JP 16th Edition carries 1764 articles, owing to the addition of 106 articles and the deletion of 15 articles.

Related Information

1. The official name of this pharmacopoeia is 第十六改正日本薬局方, and may be abbreviated as 日

局十六, 日局16, JP XVI or JP 16.

2. The English name of this pharmacopoeia is The Japanese Pharmacopoeia, Sixteenth Edition.