JP drafts for public comments, September 2, 2024 - November 30, 2024
New monographs (excluding the following monographs harmonized with USP as a pilot basis)
- Aripiprazole Tablets[180KB] (008-2409eng.pdf)
- Blonanserin[124KB] (009-2409eng.pdf)
- Blonanserin Powder[120KB] (010-2409eng.pdf)
- Blonanserin Tablets[123KB] (011-2409eng.pdf)
- Celecoxib Tablets[101KB] (012-2409eng.pdf)
- Esomeprazole Magnesium Hydrate[180KB] (013-2409eng.pdf)
- Esomeprazole Magnesium Delayed-Release Capsules[199KB] (014-2409eng.pdf)
- Limaprost Alfadex Tablets[177KB] (015-2409eng.pdf)
- Perospirone Hydrochloride Hydrate[131KB] (016-2409eng.pdf)
- Perospirone Hydrochloride Tablets[165KB] (017-2409eng.pdf)
- Pregabalin[191KB] (018-2409eng.pdf)
- Pregabalin Capsules[133KB] (019-2409eng.pdf)
- Pregabalin Orally Disintegrating Tablets[137KB] (020-2409eng.pdf)
New monographs (monographs harmonized with USP as a pilot basis)
These draft monographs are obtained as results of pilot bilateral harmonization with the United States Pharmacopeia (USP) (Press Release (October 2023) [192KB]). Please read the announcement described as a preface of each draft monograph because pilot efforts regarding international harmonization were performed in examining these draft monographs.
- Dapagliflozin Propylene Glycolate Hydrate[162KB] (021-2409eng.pdf)
- Dapagliflozin Propylene Glycolate Tablets[193KB] (022-2409eng.pdf)
(Note) The description of each of these drafts differs from the description required in the Guideline for Drafting Monographs for The Japanese Pharmacopoeia, Nineteenth Edition (Partial revision) in that the final concentration of a solution is indicated in the procedure for preparing the solution. To be used as references for preparation of solutions, the preparation procedures of the solutions in accordance with the ordinary descriptions of the Japanese Pharmacopoeia describing specific weighing amounts (Dapagliflozin Propylene Glycolate [101KB], Dapagliflozin Propylene Glycolate Tablets [173KB]) are provided. The preparation procedure of solutions describing specific weighing amounts are provided as a reference and has been verified by the manufacturer who prepared the drafts. Please note that these procedures are not monographs listed in the Japanese Pharmacopoeia.
New monographs (Crude drug)
- Mashiningan Extract[162KB] (023-2409eng.pdf)
Ultraviolet-visible reference spectra
- Blonanserin[77.6KB] (024-2409eng.pdf)
- Esomeprazole Magnesium Hydrate[40.1KB] (025-2409eng.pdf)
- Perospirone Hydrochloride Hydrate[80.4KB] (026-2409eng.pdf)
Infrared reference spectra
- Blonanserin[82.5KB] (027-2409eng.pdf)
- Esomeprazole Magnesium Hydrate[82.2KB] (028-2409eng.pdf)
- Perospirone Hydrochloride Hydrate[120KB] (029-2409eng.pdf)
- Pregabalin[78.9KB] (030-2409eng.pdf)
To send the comment on these drafts, the guidance is as follows:
- Download the form for comments in Word format[67.0KB]
- Fill in the form
- Prepare and attach the supportive data that scientifically validate the comment when appropriate
- Send it to the email address: JPdraft-eng[at]pmda.go.jp
Note:
For the purpose of security, this email address is partly incorrect. Please replace [at] with @ when sending an email.
Related Information
Note:
The information submitted with the comments may be released to the public whenever necessary (except the individual name, organization, address, telephone & fax numbers and e-mail address or the attached supportive data).
Your comments will be considered for the preparation of JP final drafts, but no individual response will be made to each comment.