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 (001-1909-2eng.pdf)

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

New monographs

• Cloperastine Fendizoate (002-1909-2eng.pdf)
• Cloperastine Fendizoate Tablets (003-1909-2eng.pdf)
• Eribulin Mesilate (004-1909-2eng.pdf)

　　  Briefing on Proposed Draft
　　　   Official Monograph “Eribulin Mesilate”

• Phenobarbital Tablets (005-1909-2eng.pdf)
• Pitavastatin Calcium Orally Disintegrating Tablets (006-1909-2eng.pdf)
• Silodosin Orally Disintegrating Tablets (007-1909-2eng.pdf)

Ultraviolet-visible reference spectra

• Cloperastine Fendizoate (008-1909-2eng.pdf)

Infrared reference spectra

• Cloperastine Fendizoate (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
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●pmda.go.jp

Note: For the purpose of security, this email address is partly incorrect. Please replace ● 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).