Pharmaceutical Administration and Regulations in Japan - Nihs

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Table 8. Revision Rates of Reimbursement Prices Year Number of products with price decrease Number of products with price increase Number of products with price unchanged Total Revision rate 1992 7,681 (−8.5%) 2,121 (0.4%) 3,771 13,573 - 8.1% 1994 8,613 (−6.8%) 2,083 (0.2%) 2,679 13,375 - 6.6% 1996 9,568 (−7.0%) 1,697 (0.2%) 1,604 12,869 - 6.8% 1997 7,718 3,394 862 11,974 - 3.0% * 1998 9,921 (−9.7%) 6 (0.0%) 1,762 11,692 - 9.7% 2000 8,935 (−7.5%) 61 (0.5%) 2,291 11,287 - 7.0% 2002 9,096 98 1,997 11,191 - 6.3% 2004 9,645 39 2,309 11,933 - 4.2% 2006 10,113 75 3,123 13,311 − 6.7% 2008 12,740 77 1,542 14,359 − 5.2% * In 1997, the overall drug price revision was -3.0% when a 1.4% rise based on the increased consumption tax rate is included. Since a new premium formula was introduced for the promotion of new drug research and resolution of problems of treatment not covered by insurance on a trial basis in 2010, above data for 2010 are not available. The numbers of drugs by formulation type are shown below for reference purpose. Number announced Oral Injection Topical Dental Total 8,676 4,010 2,733 36 15,455 2011-3 - 195 -
Table 9. Requirements for Applying Premiums Premium for innovativeness (rate: 70-120%) Applied to new drug products in the NHI price lists meeting all of the following requirements: 1) The newly entered drug has a clinically useful new mechanism of action. (1) 2) The newly entered drug has been shown objectively to have greater efficacy and safety than existing (comparator) drugs in the same class. 3) The newly entered drug has been shown objectively to improve treatment of the indicated disease or trauma. (2) Premium for usefulness I (35-60%) (3) (4) (5) Applied to new drug products in the NHI price lists that meet two of the three requirements listed above Premium for usefulness II (5-30%) Applied to new drug products in the NHI price lists that meet one of the following requirements (excluding products to which the innovativeness premium or usefulness premium (I) is applied): 1) The newly entered drug has a clinically useful new mechanism of action. 2) The newly entered drug has been shown objectively to be more effective and safe than existing (comparator) drugs in the same class. 3) The newly entered drug has been shown objectively to offer, as a result of formulation improvement, greater therapeutic usefulness than other drugs in the same class. 4) The newly entered drug has been shown objectively to improve treatment of the indicated disease or trauma. Premium for pediatric use (5-20%) Applied to new drug products in the NHI price lists meeting all of the following requirements: 1) The newly entered drug is explicitly shown in the Indications section or Dosage and Administration section to be indicated for children (including infants, suckling infants, newborns, and low-birthweight infants). 2) The premiums for pediatric use must not have been given to comparator drugs available in the NHI price lists. Premium for marketability I (10-20%) Applied to new drug products in the NHI price lists meeting all of the following requirements: 1) Orphan drugs pursuant to the provisions of Article 77-2 of the Pharmaceutical Affairs Law in the NHI price lists for which the orphan indications for the disease or trauma are the main indications of the drugs concerned. 2011-3 - 196 -
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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
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prepared, reported in writing and r
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Page 159 and 160: approval (known or unknown). g) Ser
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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
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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
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Page 199 and 200: 0212-(6) of the Health Policy Burea
Page 201: 1998 Sept. 1997 5% 2% (Long listed
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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Pharmaceutical Administration and Regulations in Japan - Nihs

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