Q1
When will the latest edition of JP be available?
The "Schedule of JP Publication" is posted on the "About JP" at the Pharmaceuticals and Medical Devices Agency (PMDA)/Japanese Pharmacopoeia (JP) website. It shows the publication schedule of JP latest editions. The publication dates are updated as soon as confirmed. No estimated date is available.
Q2
When will the latest edition of JP be available in English?
The "Schedule of JP Publication" is posted on the "About JP" at the Pharmaceuticals and Medical Devices Agency (PMDA)/Japanese Pharmacopoeia (JP) website. It shows the publication schedule of JP latest editions. The JPs are originally prepared in Japanese and are translated to English after publication of Japanese version. The translation may take about a year depending on the volume of texts. The translated editions are uploaded as soon as possible. No estimated date is available.
The JP contents and preface in English may be available on the "JP Editions and Supplements" page prior to posting of the JP English edition.
Q3
When is the effective date of the JP edition?
The official date of Japanese Pharmacopeia (JP) edition or supplement is indicated in the Ministerial Notification issued by the Ministry of Health, Labour and Welfare (MHLW). The last date of transitional period from the old to the new standards is also specified in the Notification. The previous standards are applicable to the pharmaceutical substances or products until the transitional period ends but all the new standards shall be completely implemented thereafter. For example, the supplement l to JP18th Edition published on December 12, 2022 came into effect on December 12, 2022 and the transitional period will end on June 30, 2024 .
Q4
Where can I find the latest edition of JP?
The Japanese Pharmacopoeia (JP) latest editions are posted on the "JP Editions and Supplements" page at the Pharmaceuticals and Medical Devices Agency (PMDA)/JP website. PMDA offers free access to the online version of JP editions without any license or registration.
Q5
How can I learn where revisions were made in JP?
Major changes to the Japanese Pharmacopoeia (JP) are described in the Preface of each JP edition and supplement.
Q6
Where can I purchase the JP editions?
The Pharmaceuticals and Medical Devices Agency (PMDA) provides Japanese Pharmacopoeia (JP) online versions for free on the PMDA/JP website. The book versions are published by the Pharmaceutical and Medical Device Regulatory Science Society of Japan (PMRJ).
PMRJ website: http://www.pmrj.jp/eng/02/01.html
Q7
Can I download the JP and share with others?
In general, all the information except signed manuscripts, etc. on this website are protected by copyright owned by the Pharmaceuticals and Medical Devices Agency (PMDA). The information shall not be changed without permission. The users are expected to comply with the copyright law.
The Ministry of Health, Labour and Welfare (MHLW) and PMDA that prepare the Japanese Pharmacopoeia (JP) editions do not claim ownership of copy rights for the editions or the supplements. Anyone may download and use the JP freely without the need to obtain permission from PMDA.
Q8
Where can I purchase the JP Reference Standards?
The Japanese Pharmacopoeia (JP) Reference Standards (except for antibiotics) are produced and distributed by the Pharmaceutical and Medical Device Regulatory Science Society of Japan (PMRJ).
PMRJ website: https://www.pmrj-rs.jp/en/
Q9
Where can I find the JP drafts or the PDG Stage 2 drafts for review and comment?
The Pharmaceuticals and Medical Devices Agency (PMDA)/Japanese Pharmacopoeia (JP) Japanese website posts the JP new and revised Japanese drafts and the Pharmacopoeial Discussion Group (PDG) Stage 2 Japanese and English drafts for public review and comment with free access (requiring no ID or password). The PMDA/JP English website posts PDG Stage 2 English drafts for public review.
Starting with the new monographs that are intended for inclusion in the Supplement I to the JP 17th edition, the drafts that are translated into English are posted on this English version of PMDA website.
PDG Stage 2 Official Inquiry
JP Japanese site for public comment
JP English site for public comment
In general, public comments are accepted till the end of next month after posting of drafts on the PMDA website.
Q10
Where can I find the brands and manufacturers of the columns that are used in the JP test methods?
Disclosure of the column information such as a brand or manufacturer name is restricted due to the law on protection of confidential business information. The users are expected to find the appropriate columns to use by referring to the description in the latest JP edition or supplement.
For your information, the information about columns used for preparing the drafts is posted on the PMDA website when the draft monographs are published for public comments. For further information, please click here.
Q11
Where can I contact for inquiries about JP?
To contact the Japanese Pharmacopoeia (JP) secretariat for a problem with the information on the JP website, please send an email to "JPinq-eng●pmda.go.jp" with the information below.
- Name
- Email address
- Sender’s business (Regulatory authority / Industry / Media / Academia (university / institute) / Other organizations / Individuals)
- Name of organization / department
- Country
- Inquiry content
(Note: This email address includes ● instead of @ for security purpose. Replacement of ● with @ is required in order to send your inquiry.)
JP secretariat belongs to:
Division of Pharmacopoeia and Standards for Drugs,
Office of Review Management
Pharmaceuticals and Medical Devices Agency (PMDA)
Q12
Even when parts of the procedures or conditions of JP test methods are changed, can I determine product conformity to the JP by the changed methods?
Issues regarding the justification for any changes of the JP test methods and their conformity to the JP will be considered case by case for individual products, hence there are no advice or responses provided by the email in FAQ No. 11 for such inquires.
Please refer to the URL below and reconsider how to plan to approach the product. For example, for products that are planned to file a marketing application in Japan, you may consult with PMDA through the applicant in Japan. Otherwise, you may consider consulting with PMDA through your affiliates operating in Japan.
https://www.pmda.go.jp/english/review-services/consultations/0002.html
Q13
The result of our product testing in line with the procedures and the conditions specified in the JP did not show the conformity to the JP, though the product had conformed to other pharmacopoeias. Would you provide the test procedures and conditions that are not specified in the JP but should be considered in order to conduct the test appropriately if any?
The email in the FAQ No. 11 above provides no advice or responses to any inquiries regarding tests at laboratory or tests for individual products. Please refer to the FAQ No. 12 above as needed.