Pharmaceutical Administration and Regulations in Japan - Nihs

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3/2007 • Establishment of regional health insurance societies (unions) Health Insurance Law • Review of the membership of the Central Social Insurance Medical Council and abolition of regulations on endorsement from organizations 2011-3 - 193 - Social Insurance Council Law 4/2007 • Revision of payment rates for illness and delivery benefits Health Insurance Law 4/2008 10/2008 • Revision of burden on elderly patients aged 70 to 74 years (10%→20%) • Expansion of liability relief measures (20%) for young children (children not older than 3 years→children before school age) • Revision of the name of the law to “Law for Assuring Healthcare for the Elderly” • Program for the optimal utilization of health expenditures • Obligation to provide preventive medical examinations for citizens covered by health insurance • Establishment of a health care system for the very elderly (older than 75 years of age) • Establishment of a fiscal control system for healthcare spending for the pre-elderly (65 to 74 years old) • Public incorporation of government-controlled health insurance programs Health insurance-related laws including Health Insurance Law Health and Medical Service Law for the Elderly Health Insurance Law 4/2012 • Abolition of nursing homes for the elderly Home-care Insurance Law Table 7. Methods of Previous Reimbursement Price Revisions Year Survey R zone Special items 1992 June 1991 15% 1994 June 1993 13% Repricing 1996 June 1995 11% Repricing 1997 Sept. 1996 10% 8% (Long listed products) Repricing Long listed products
1998 Sept. 1997 5% 2% (Long listed products) 2000 Sept. 1999 Range adjusted, 2% 2002 Sept. 2001 Range adjusted, 2% 2004 Sept. 2003 Range adjusted, 2% 2006 Sept. 2005 Range adjusted, 2% 2008 Sept. 2007 Range adjusted, 2% 2010 Sept. 2009 Range adjusted, 2% Repricing Long listed products Repricing Range adjusted, 2% Repricing Long listed products (Special adjustment, 4, 5, 6%) Repricing Long listed products (Special adjustment, 4, 5, 6%) 1/2 : JP products entered by brand name Repricing Long listed products (Special adjustment, additional 2%, new 8%) 5%: JP products entered by brand name Repricing Long listed products (Special adjustment, 4%, 5%, 6%) 1/2: JP products entered by brand name Repricing Long listed products (Special adjustment, additional 2.2%, new 6%) 1/2: JP products entered by brand name 2011-3 - 194 -
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2011.3 INFORMATION IN ENGLISH ON JA
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Table of Contents CHAPTER 1 ···
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4.1 GMP Compliance Reviews ····
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TABLE 3 DATA TO BE SUBMITTED WITH A
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eliability of application data. Fol
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3) Control of household products co
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health care information-processing
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eevaluation of gastrointestinal dru
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contribution to drug research and d
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Ministry of Health, Labour, and Wel
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Committee on Japanese Pharmacopoeia
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CHAPTER 2 Pharmaceutical Laws and R
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11) (License standards, restriction
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of approvals and licenses, approval
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2) Classification according to hand
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(3) Quasi-drug marketing business l
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manufacturer submits an MF registra
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(4) On-site surveys for accreditati
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y testing facilities for nonclinica
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Implementation of Clinical Studies
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December 21, 2005. Based on this La
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Activities Encouraging Illicit Cond
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(7) General review conference (main
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diseases, a decision must be made w
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and use of drugs for pediatric use
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codevelopment group and requirement
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January 28, 2011 entitled “Issuan
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pharmaceutical excipients, physicoc
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application review of raw materials
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half of the 1980s and there were al
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Patent right 1 Patent right 2 Calcu
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Foreign manufacturer with manufactu
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Table. 1 List of Main Controlled Su
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Table. 2 Divisions of the Pharmaceu
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acceptance of the data is condition
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p) Consultations on compliance with
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http://www.pmda.go.jp/topics/file/
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Approval of Manufacturing/Marketing
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Summary of biopharmaceutics and ass
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1998 and partial revision by Office
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evised or established concerning ph
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are performed on the basis of the G
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Pharmaceuticals (ICH S2B) (Notifica
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Quality Assurance Units Chapter 3 (
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y made to Notification No. 813 of t
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international harmonization of appr
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clinical exploration and developmen
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the primary objective of exploring
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dose not exceeding 1/100 of the dos
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must be analyzed precisely and obje
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(21) Structure and Content of Clini
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approved drugs and post-marketing c
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specified in the ICH guidelines (IC
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standards for the sponsoring of cli
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management of clinical trials (Arti
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PFSB dated October 1, 2008 and Offi
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trial sponsors (Article 59). Howeve
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e judged by personnel of the qualit
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standards, the Minister of Health,
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esults thereof. * Manufacturer, etc
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is clear that the items relating to
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carries out the duties set forth be
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in the two countries. These mutual
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PMSB dated February 22, 2000), Guid
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Information on approval reviews for
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Nonclinical studies Clinical studie
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(Table 3) Drug classification syste
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(Table 4) Drug classification syste
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Module 2 2.3: Quality overall summa
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Step 5* Q1A(R2) Q1B Q1C Q1D Q1E Q2
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Step 5* E1 Step 4* E2A Code E2B(M)
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1998. Furthermore, a new guideline,
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supervisor, quality assurance super
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work is required and retention of c
Page 149 and 150: prepared, reported in writing and r
Page 151 and 152: etain these reports. [5] The safety
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Page 155 and 156: surveyed, analytical method and oth
Page 157 and 158: marketers’ compliance surveys by
Page 159 and 160: approval (known or unknown). g) Ser
Page 161 and 162: Information about adverse drug reac
Page 163 and 164: 6.2 Periodic Safety Reports (Articl
Page 165 and 166: Reexamination is based on submissio
Page 167 and 168: Post-marketing surveillance (PMS) s
Page 169 and 170: Planning of early post-marketing su
Page 171 and 172: (MHLW) (PMDA [KIKO]) Selection of r
Page 173 and 174: and the Role of the Regulatory Auth
Page 175 and 176: which they are entered in package i
Page 177 and 178: the beginning of the Precautions wh
Page 179 and 180: 1.5 Entries for Biological Products
Page 181 and 182: 2.2 Pharmaceutical Interview Forms
Page 183 and 184: the basis of an order issued in cas
Page 185 and 186: the journals of the Japan Medical A
Page 187 and 188: Labeling requirements of excipients
Page 189 and 190: No PMDA safety assessment team (5 t
Page 191 and 192: CHAPTER 6 Health Insurance Programs
Page 193 and 194: coverage was changed to 80% of medi
Page 195 and 196: OF DRUGS LISTED IN THE NHI DRUG PRI
Page 197 and 198: (excluding those in the JP) in the
Page 199: 0212-(6) of the Health Policy Burea
Page 203 and 204: Table 9. Requirements for Applying
Page 205 and 206: Within 60 days as a rule or 90 days
Page 207 and 208: Index 1 15-Day reports (ADR) ......
Page 209 and 210: Quality Standards and Government Ce
Page 211 and 212: (MHLW) Office of New Drug III (PMDA
Page 213 and 214: Specified biological products .....
Page 215 and 216: (Chapter 4) Kazuyo MARUCHI Product
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