Transcription of 令和元年薬機法改正とICH Q12 について
1 2021 4 1 ich q12 2021 12 14 ICH 30 11 1 - 1 2 GMP QMS 30 1 - 1 3
2 30 1 - 1 4 PAS Prior Approval Supplement- MajorChanges Majorvariations of Type II 30 CBE-30 Changes Being Effected in 30 days Moderate Changes Minor variations of Type IB CBE-0 Changes Being Effected Moderate Changes 30 Minor variations of Type IAIN(immediate notification)
3 AnnualReport(Minor Changes)Minor variations of Type IA 12 CTD Module3 established conditionsCTD Module3 30 1 - 1 5 PACMP PACMP PACMP ICH ICHQ12 PACMP 30 1 - 1 6 1
4 2 GMP GMP GMP PMDA PMDA PMDA PMDA PACMP 30 PACMP 30 1 - 1 7 PACMP CTD GMP GMP PMDA Q10 28 2 12 PMDA PACMP CTD.
5 Common Technical Document ICH 30 1 - 1 8 ich q12 30 1 - 1 9 PACMP 30 28 1 10 (2)
6 30 12 25 11 (1) .. (2).
7 (3) (4) (5) (6) (1) (2) (3) (1) (2) (3) (4 (1) (2).)
8 (3) .(5) .(2) .(1)(2) .(6) 12 .(4) 63 12 PACMP PMDA PMDA PMDA PACMP
9 Post-Approval Change Management Protocol PACMP 8 1 80 2 5 13 PACMP 40 1 2 68 68 ICH Q10
10 PMDA MF
