JP drafts for public comments, September 1 - 30, 2016
New monographs (Chemical drug)
- Acarbose (001-1609eng.pdf)
- Acarbose Tablets (002-1609eng.pdf)
- Chloramphenicol and Colistin Sodium Methanesulfonate Ophthalmic Solution (003-1609eng.pdf)
- Clomipramine Hydrochloride Tablets (004-1609eng.pdf)
- Clotiazepam Tablets (005-1609eng.pdf)
- Entacapone (006-1609eng.pdf)
- Entacapone Tablets (007-1609eng.pdf)
- Insulin Aspart (Genetical Recombination) (008-1609eng.pdf)
- Irbesartan Tablets (009-1609eng.pdf)
- Pazufloxacin Mesilate Injection (010-1609eng.pdf)
- Pyridoxal Phosphate Hydrate (011-1609eng.pdf)
- Tramadol Hydrochloride (012-1609eng.pdf)
- Zonisamide Tablets (013-1609eng.pdf)
New monographs (Crude drug)
- Goreisan Extract (014-1609eng.pdf)
Ultraviolet-visible reference spectra
- Entacapone (015-1609eng.pdf)
- Pyridoxal Phosphate Hydrate (016-1609eng.pdf)
- Tramadol Hydrochloride (017-1609eng.pdf)
Infrared reference spectra
- Acarbose (018-1609eng.pdf)
- Entacapone (019-1609eng.pdf)
- Pyridoxal Phosphate Hydrate (020-1609eng.pdf)
- Tramadol Hydrochloride (021-1609eng.pdf)
To send the comment on these drafts, the guidance is as follows:
- Download the form for comments in Word format
- Fill in the form
- Prepare and attach the supportive data that scientifically validate the comment when appropriate
- Send it to the email address: JPdraft1609eng@pmda.go.jp
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