The Japanese Pharmacopoeia (JP) is the pharmaceutical standard that the Minister of Health, Labour and Welfare (MHLW) establishes to regulate the properties and quality of drugs. Based on the results of discussions at the JP Expert Committees, the Office of Standards and Guidelines Development at the Pharmaceuticals Medical Devices Agency (PMDA) prepares the drafts of new and revised monographs and general texts that are intended for inclusion in the JP edition. The proposed revisions to the JP edition are quarterly published for public comments. The drafts that are intended for inclusion in the JP are posted on the Japanese version of PMDA website in the beginning of March, June, September, and December. The comment period is a month or three months as indicated on each page. After further review of the drafts with the comments by the JP Expert Committees, the final drafts will be submitted to MHLW. The official texts are adopted and promulgated by the Ministry. The Schedule of JP Publication is available under the About JP on this site.
Starting with the new monographs that are intended for inclusion in the Supplement I to the JP 17th edition and a part of new general texts that are intended for inclusion in the Supplement II to the JP 17th edition, the drafts that are translated into English are posted on this English version of PMDA website. PMDA invites public comments from the outside of Japan not only in Japanese but also in English as a trial. No response will be made to each comment. However, the public comments will be used for developing the JP final drafts. The purpose of posting the English version of JP drafts is to provide information to stakeholders outside Japan who are not familiar with the Japanese language. The marketing authorization holders in Japan are expected to follow the guidance on the Japanese version of PMDA website. Moreover, when and if any discrepancy is found between the Japanese draft and the English draft, the former should be regarded as authentic.
The guidance and the form for comment are as shown on each page below.