JP drafts for public comments, September 1 - November 30, 2021
New monographs
- Anastrozole Tablets[104KB] (003-2109eng.pdf)
- Bicalutamide Tablets[117KB] (004-2109eng.pdf)
General Tests and General Information related to Chromatography
Please refer to the Briefing Note[580KB] as well.
New General Test
- 2.00 Chromatography[704KB] (005-2109eng.pdf)
Note:
Due to the progress in harmonization of G-20 Chromatography, the description of line 420-423 in the JP draft were changed as follows:
Before the change: ◇To verify the suitability of the method under the new conditions, assess the relevant analytical performance characteristics potentially affected by the change.◇
After the change: To verify the suitability of the adjusted pharmacopoeial procedure, assess the relevant analytical performance characteristics potentially affected by the change.
Revised General Test
- 2.01 Liquid Chromatography[189KB] (006-2109eng.pdf)
- 2.02 Gas Chromatography[183KB] (007-2109eng.pdf)
New General Information
- Control Strategies and Change Control Concepts at Each Stage of Lifecycle of Chromatography (Change Control in Lifecycle of Chromatography)〈G1-5-181〉[199KB] (008-2109eng.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.