JP drafts for public comments, June 3 - 30, 2019
General information
- A basic concept of the quality assurance on biotechnological products (biopharmaceuticals) (001-1906eng.pdf)
- Control of Culture Media and Strains of Microorganisms Used for Microbial Test Methods (002-1906eng.pdf)
- Tablet Hardness Determinations (003-1906eng.pdf)
- Packaging Integrity Evaluation of Sterile Products (004-1906eng.pdf)
- Leak Tests for Packaging of Sterile Products (005-1906eng.pdf)
JP drafts for public comments, June 3 - August 31, 2019
New monographs
- Copovidone (006-1906eng.pdf)
- Telmisartan and Amlodipine Besilate Tablets (007-1906eng.pdf)
- Triazolam (008-1906eng.pdf)
New monographs (Crude drug)
- Byakkokaninjinto Extract (009-1906eng.pdf)
- Unseiin Extract (010-1906eng.pdf)
Ultraviolet-visible reference spectra
- Triazolam (011-1906eng.pdf)
Infrared reference spectra
- Copovidone (012-1906eng.pdf)
- Triazolam (013-1906eng.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: JPdraft1906eng●pmda.go.jp
Note: For the purpose of security, this email address is partly incorrect. Please replace ● 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).