Publication Schedule of Japanese Pharmacopoeia JP 17th

Publication Schedule of Japanese Pharmacopoeia JP 17th Edition (JP17) Published in March 7, 2016 JP 18th Edition (JP18) To be published in 2021 Supple...

0 downloads 105 Views 56KB Size
Publication Schedule of Japanese Pharmacopoeia JP 17th Edition (JP17) Published in March 7, 2016

・Basic Principles for Preparation of JP18 (Published in October 2016)

Supplement I to JP17

・Guideline for Preparation of JP18 Draft

Published in December 1, 2017

(Published in January 2017)

Supplement Ⅱ to JP17 To be published in May 2019

JP 18th Edition (JP18) To be published in 2021 *English version is published within a year after JP publication. 1

Publication Schedule Supplement II to Japanese Pharmacopoeia 17th Edition New or revised drafts are quarterly posted on PMDA website and published in PMRJ* Japanese Pharmacopoeial Forum (JPF) for public review and comment.

Posting Date Dec. 1, 2016 Mar. 1, 2017 Jun. 1, 2017

PMRJ*: Pharmaceutical and Medical Device Regulatory Science Society of Japan

The comments, which are due in a month or three months from each posting date as specified in each forum, will be reviewed. The drafts posted between December 2016 and March 2018 will be on the Supplement II to JP17.

Sep. 1, 2017 Dec. 1, 2017 Mar. 1, 2018

Public comments are invited on the PMDA website; http://www.pmda.go.jp/english/rs-sb-std/standardsdevelopment/jp/0013.html

December 2018 - PMDA final drafts to MHLW* MHLW*: Ministry of Health, Labour and Welfare

The drafts will be reviewed at the Committee on JP under the Pharmaceutical Affairs and Food Sanitation Council and will be posted on MHLW website for public review and comment.

May 2019 – Publication of Supplement II to JP17 2