JP drafts for public comments, June 3 - 30, 2019
General information
- A basic concept of the quality assurance on biotechnological products (biopharmaceuticals)[338KB] (001-1906eng.pdf)
- Control of Culture Media and Strains of Microorganisms Used for Microbial Test Methods[67.4KB] (002-1906eng.pdf)
- Tablet Hardness Determinations[46.2KB] (003-1906eng.pdf)
- Packaging Integrity Evaluation of Sterile Products[202KB] (004-1906eng.pdf)
- Leak Tests for Packaging of Sterile Products[208KB] (005-1906eng.pdf)
JP drafts for public comments, June 3 - August 31, 2019
New monographs
- Copovidone[269KB] (006-1906eng.pdf)
- Telmisartan and Amlodipine Besilate Tablets[189KB] (007-1906eng.pdf)
- Triazolam[229KB] (008-1906eng.pdf)
New monographs (Crude drug)
- Byakkokaninjinto Extract[334KB] (009-1906eng.pdf)
- Unseiin Extract[155KB] (010-1906eng.pdf)
Ultraviolet-visible reference spectra
- Triazolam[44.0KB] (011-1906eng.pdf)
Infrared reference spectra
- Copovidone[101KB] (012-1906eng.pdf)
- Triazolam[126KB] (013-1906eng.pdf)
To send the comment on these drafts, the guidance is as follows:
- Download the form for comments in Word format[67.5KB]
- Fill in the form
- Prepare and attach the supportive data that scientifically validate the comment when appropriate
- Send it to the email address: JPdraft1906eng[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 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).