JP Drafts (September 30, 2019)

JP drafts for public comments, September 30 - October 30, 2019

New general information

• Bacterial Endotoxins Test and alternative methods using recombinant protein-reagents for endotoxin assay[205KB] (001-1909-2eng.pdf)

JP drafts for public comments, September 30 - December 30, 2019

New monographs

• Cloperastine Fendizoate[217KB] (002-1909-2eng.pdf)
• Cloperastine Fendizoate Tablets[98.3KB] (003-1909-2eng.pdf)
• Eribulin Mesilate[482KB] (004-1909-2eng.pdf)

Briefing on Proposed Draft
　Official Monograph “Eribulin Mesilate”[37.5KB]

• Phenobarbital Tablets[52.4KB] (005-1909-2eng.pdf)
• Pitavastatin Calcium Orally Disintegrating Tablets[76.0KB] (006-1909-2eng.pdf)
• Silodosin Orally Disintegrating Tablets[176KB] (007-1909-2eng.pdf)

Ultraviolet-visible reference spectra

• Cloperastine Fendizoate[93.0KB] (008-1909-2eng.pdf)

Infrared reference spectra

• Cloperastine Fendizoate[117KB] (009-1909-2eng.pdf)

 

To send the comment on these drafts, the guidance is as follows:

1. Download the form for comments in Word format[67.5KB]
2. Fill in the form
3. Prepare and attach the supportive data that scientifically validate the comment when appropriate
4. Send it to the email address: JPdraft1909-2eng[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

• Columns (Chemical drug)

 

Note: The information provided with the comment 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).