Pharmaceutical Administration and Regulations in Japan - Nihs

Management Information ················· 174
3.1 Distribution of Emergency Safety
Information (Doctor Letters or Yellow Papers)
······················································ 175
3.2 Distribution of Information by 'Notices of
Revision of Precautions' ······················ 177
3.3 Dissemination of Information for Drugs
That Have Completed Reexamination or
Reevaluation ···································· 177
3.4 Dissemination of ADR Information by the
Pharmaceuticals and Medical Devices
Safety Information (Information on Adverse
Reactions to Drugs) ··························· 178
3.5 Distribution of Information by Drug Safety
Update ············································ 178
3.6 Commentaries on "Precautions" in
Package Inserts of New Drugs ············· 178
4. Electronic Information Dissemination
179
5. Package Inserts of Non-prescription
Drugs ·········································· 179
CHAPTER 6 ······································· 184
HEALTH INSURANCE PROGRAMS AND DRUG
PRICING IN JAPAN ······························· 184
1. History of Health Insurance Programs
184
2. Medical Benefits Offered under Health
Insurance Programs ······················· 185
3. Reimbursement of Medical Fees · 186
4. National Health Insurance Drug Price
List 187
5. Pricing Formula for Reimbursement
Price Revisions of Drugs Listed in the NHI
vi
Drug Price List ······························ 187
6. Recent Revisions of the NHI Drug
Price List ······································ 189
7. Determination of Reimbursement
Prices for New Drugs ······················ 190
8. Entry of Generic Drugs in the NHI
Drug Price List ······························ 191
FIG. 1 ORGANIZATION OF MINISTRY OF HEALTH,
LABOUR, AND WELFARE ······················· 12
FIG. 2 ORGANIZATION OF PHARMACEUTICAL
AND FOOD SAFETY BUREAU (PFSB) AND
PHARMACEUTICALS AND MEDICAL DEVICES
AGENCY (PMDA [KIKO]) ····················· 13
FIG. 3 ORGANIZATION OF THE
PHARMACEUTICAL AFFAIRS AND FOOD
SANITATION COUNCIL (PAFSC) ·············· 15
FIG. 4 FLOWCHART OF PATENT-LIFE
EXTENSION ······································ 54
FIG. 5 FLOWCHART OF APPROVAL REVIEW ······· 55
FIG. 6 PROCEDURE FOR MANUFACTURING AND
MARKETING OF DRUGS FOR OVERSEAS
MANUFACTURERS IN JAPAN ··················· 56
FIG. 7. FLOWCHART OF DRUG LISTING IN JAPANESE
PHARMACOPOEIA ······························· 57
TABLE. 1 LIST OF MAIN CONTROLLED
SUBSTANCES ···································· 58
TABLE. 2 DIVISIONS OF THE PHARMACEUTICAL
AND FOOD SAFETY BUREAU IN CHARGE OF
CERTIFICATION WORK ························· 60
FIG. 8 FLOWCHART OF NEW DRUG
DEVELOPMENT AND APPROVAL ············ 124