The Japanese Pharmacopoeia
The Japanese Pharmacopoeia (日本薬局方?) is the official
Pharmacopoeia of Japan. It is published by the Pharmaceuticals and Medical
Devices Agency (独立行政法人 医薬品医療機器総合機構?) under the authority of the Ministry of Health, Labour
and Welfare. The first edition was published on 25 June, 1886, with revisions
being issued from time to time. The current revision is number 16, issued on 24
March 2011.
The Japanese Pharmacopoeia 17th edition (JP XVII) English
translation is fully endorsed by the society of the Japanese Pharmacopoeia. It
defines the specifications, criteria and standard test methods necessary to
properly ensure the quality of medicines in Japan. The Japanese language
edition was effective from 1st April 2016.
Key features:
·
General Notices, General Rules for Crude Drugs, General
Rules for Preparations: revised and expanded.
·
Official monographs: 76 new monographs and 473 revised
monographs.
·
General tests, processes and apparatus: 23 new standards
and 10 revised standards.
·
Infrared reference spectra: 21 new spectra and 2 revised
spectra.
·
Ultraviolet-visible reference spectra: 14 new spectra and 2
revised spectra.
The JP aims to:
1. Include all drugs which are important from the viewpoint of
health care and medical treatment.
2. Make qualitative improvement by introducing the latest
science and technology.
3. Promote internationalisation.
4. Make prompt partial revision as necessary and facilitating
smooth administrative operation.
5. Ensure transparency regarding the revision, and
disseminating the JP to the public.
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