Japanese HPLC requirements
Posted: Thu Sep 26, 2013 8:13 pm
Getting ready to file a JNDA with the Japanese regulatory agency.
The HPLC methods have already been filed in US and EU. Is there any "Japan" specific requirements I may neeed in my methods? System suitability requirements, or other non-routine requirements typically requested by the Japanese regulatory agency (PMDA)?
Thanks for any info.,
HPLCer
The HPLC methods have already been filed in US and EU. Is there any "Japan" specific requirements I may neeed in my methods? System suitability requirements, or other non-routine requirements typically requested by the Japanese regulatory agency (PMDA)?
Thanks for any info.,
HPLCer