Transcription of Topics 「第 6回日台合同セミナー」を台北にて開催
1 Topics 6 .. Food and Drug Administration TFDA . Center for Drug Evaluation CDE . 6 2011 11 22 . 110 .. 1. GMP .. 11 21 .. PMDA .. 12 7 8 36 .. 4 . GMP Good Manufacturing Practice . 2010 .. 6 JPMA news letter (2012/01). 37.. TFDA Dr. Meir-Chyun Tzou . TFDA .. TFDA .. 2 3 . 2011 8 2 IND pre-NDA . Domestic Innovation Consultation Project . Normal Pro- . ject . Active Project 2 . Normal project pre-clinical . 2 4 . for-cause pre-filing meeting . IND inspec-tion . 151 . 4. Active project 31 PIC/S GMP . TFDA . pre-filing meeting . IND 2011 10 . GMP . NDA 2 4 . follow-up.
2 PIC/S Plant Master Project 4 File review . PMF.. 5. / SOP . / / 1 PIC/S GMP . 71,005 705 . TFDA CDE PIC/S 517 PIC/S 188 .. PIC/S GMP 2014 12 31 . IND/NDA 2014 12 31 . GMP .. ICH . FDA . EMA 36 . PIC/S .. follow- . up .. GMP 2 IND Investigational New Drug .. TFDA Ms. Li-Feng Chen . 3 NDA New Drug Application . PIC . 36 PIC-Scheme . 4 PIC/S Pharmaceutical Inspection Convention/. 170 . Scheme GMP .. 5 SOP Standard Operating Procedures . GMP . JPMA news letter (2012/01) 6 . 38. CDE TFDA . INAH .. 1 2 TNF- . TFDA . B HCV . CDE Chen RMP TNF- . TFDA Chen . REMS Risk Evaluation Mitigation Strat.
3 Egies TNF- . Ms. Chen . Dr. Chen REMS RMP Risk Manage- RMP . ment Program Carbamazepine . Rosiglitazone . TNF- Pioglitazone . 1998 Carbamazepine . 1/ .. 2011 . FDA EMA Physician/Pharmacist letter . B .. 10 . BCG 100 .. B . 15 20% ) . RMP PMDA . TNF- . RMP .. TNF- . 6 JPMA news letter (2012/01). 39.
