Pharmaceutical Administration and Regulations in Japan - Nihs

Phase I of clinical studies
Designation of drugs ............................ 155
Phase I of clinical studies ...................... 87 General ................................................... 32
Phase II of clinical studies ......................... 87 System .................................................. 154
Phase III of clinical studies ....................... 88 Reexamination and reevaluation
Phase III of clinical studies ................... 88 Information for drugs which completed
PMS ........................................................... 135
reexamination or reevaluation ........ 177
SOP ....................................................... 138 Reexamination and reevaluation
Post-marketing surveillance (PMS) ........... 135 Compliance review data ........................ 149
Precautions (package inserts) ................. 169 Reimbursement prices for new drugs ....... 190
Prescription drugs ...................................... 21 Research and Development Division (HPB)5
Prescription Drugs→ Approval application: Prescription Review drugs of products designated for priority
Prevention of Medical Accidents ............... 51 face-to-face advice .................................. 40
Pricing formula for reimbursement price
Reviews and Guidance by the PMDA
revisions ................................................. 188 (KIKO) .................................................... 62
Priority Review .......................................... 39
Priority reviews .......................................... 16
S
Procedures for Conduct of Clinical Studies→
Safety Division (PFSB) ............................... 4
Product Recalls ............................... → Recall
safety information
Product recalls (GMP)
Safety information
Product recalls (GMP) .......................... 114
Electronic information dissemination .... 179
Public disclosure of information on new
Periodic safety reports ......................... 156
drug development
Reporting system by Medical Personnel153
Public disclosure of information on new
WHO safety monitoring program ....... 153
drug development ............................. 121
Safety Measures against Bovine .............. 51
Safety monitoring
R
During clinical studies .......................... 97
Recent revisions of NHI drug price list ...... 189 Safety studies
Reevaluation
Requirements ......................................... 85
General ................................................... 32 Self-inspections of manufacture (GMP)
System ................................................... 158 Self-inspections of manufacture (GMP)114
Reexamination
SOP for PMS ............................................ 138
Data and procedures ............................ 156 Specifications of drugs:
Data for review ..................................... 105 Guidelines:Specifications of drugs:
Designated classifications ..................... 158 Guidelines .............................................. 74
2011-3 - 205 -