Japanese Pharmaceutical Affairs Authorities Regulatory Documents - July 2003 Full List Single User License - TABLE OF CONTENTS I. CABINET II. REGULATORY DOCUMENTS FROM THE MINISTRY OF HEALTH, LABOR AND WELFARE (MHLW) AND THE AFFILIATED STRUCTURES III. REGULATORY DOCUMENTS FROM OTHER AUTHORITIES IV. DOCUMENTS FROM INDUSTRY GROUPS V. MISCELLANEOUS Note concerning the translation of the titles I. CABINET Laws, Orders and Notifications Issuer - Date - Title * Law No. 102 (July 2, 2003) - Law concerning the Preparation of Laws related to the MHLW for the Purpose of Extending Efforts for Reforms Affecting the Public Corporations * Cabinet Order No. 304 (July 4, 2003) - Cabinet Order on designation of the Severe Acute Respiratory Syndrome (SARS) as a specified infection under the Article 6, Paragraph 6 of the Law Concerning the Prevention of Infections and Medical Care for Patients of Infections * Cabinet Order No. 305 (July 4, 2003) - Cabinet Order on the designation of the Severe Acute Respiratory Syndrome (SARS) as an infectious disease under the Article 34 of the Quarantine Act Orders and Notifications Cabinet The executive branch of the Government of Japan Cabinet Office Coordinate the Cabinet and supports the Prime Minister The highest level administrative documents issued by the Prime Minister II. REGULATORY DOCUMENTS FROM THE MINISTRY OF HEALTH, LABOR AND WELFARE (MHLW) AND THE AFFILIATED STRUCTURES Ordinances, Notifications and Notices Issuer - Date - Title Minister of Health, Labor and Welfare * MHLW Ordinance No. 117 (July 10, 2003) - Ministerial Ordinance partially revising the Enforcement Regulations of the Bleeding and Blood Donor Supply Service Control Law * MHLW Ordinance No. 118 (July 10, 2003) - About the standards of management of the organization and structure of the facilities for blood collection * MHLW Ordinance No. 120 (July 14, 2003) - Ministerial Ordinance on prevention of infectious disease in relation with the enforcement of the Cabinet Order on designation of the Severe Acute Respiratory Syndrome (SARS) as a specified infection under the Law Concerning the Prevention of Infections and Medical Care for Patients of Infections Ordinances Notifications Communications Bureaus of the MHLW PFSB: Pharmaceutical and Food Safety Bureau HPB: Health Policy Bureau HIB: Health Insurance Bureau HSB: Health Service Bureau LSB: Labor Standards Bureau ESB: Employment Security Bureau Divisions of PFSB GA: General Affairs Division ELD: Evaluation and Licensing Division SD: Safety Division ND: Compliance and Narcotics Division BBPD: Blood and Blood Products Division FSD: Food Sanitation Department The highest level administrative documents issued only by the Minister of Health, Labor and Welfare REGULATORY DOCUMENTS FROM THE MINISTRY OF HEALTH, LABOR AND WELFARE (MHLW) AND THE AFFILIATED STRUCTURES (CONT.) * MHLW Ordinance No. 121 (July 14, 2003) - Ministerial Ordinance on the revision of the Enforcement Regulations of the Quarantine Act in relation to the Cabinet Order on the designation of the Severe Acute Respiratory Syndrome (SARS) as an infectious disease under the Article 34 of the Quarantine Act * MHLW Ordinance No. 3 / Ministry of Agriculture, Forestry and Fisheries Ordinance No. 3 (July 14, 2003) - Prevention of infectious disease in relation with the enforcement of the Cabinet Order on designation of the Severe Acute Respiratory Syndrome (SARS) as a specified infection under the Article 6, Paragraph 6 of the Law Concerning the Prevention of Infections and Medical Care for Patients of Infections * MHLW Ordinance No. 123 (July 17, 2003) - Ministerial Ordinance partially revising the Enforcement Regulation of the Pharmaceutical Affairs Law [designated medicines, powerful drugs] * MHLW Ordinance No. 126 (July 29, 2003) - Ministerial Ordinance partially revising the Ministerial Ordinance on the synthetic colorants that can be used in the medicinal products * MHLW Ordinance No. 127 (July 31, 2003) - Ministerial Ordinance partially revising the Ministerial Ordinance on Enforcement Regulation of the Food Sanitation Law * MHLW Notification No. 246 (July 3, 2003) - Document partially revising the Standards for materials originating from living organisms * MHLW Notification No. 247 (July 4, 2003) - Document partially revising the notified matters established by the Minister of the Health, Labor and Welfare in relations with the treatment-related regulations, and medicinal products-related regulations, and treatment standards - related regulations * MHLW Notification No. 248 (July 4, 2003) - Document partially revising the prices of medicinal products in use (price standards for medicines prescribed under the Health Insurance System) * MHLW Notification No. 249 (July 10, 2003) - Document on the abolishment of the designation of an orphan drug under the provisions of the Article 77-2, Paragraph 1 of the Pharmaceutical Affairs Law * MHLW Notification No. 250 (July 10, 2003) - Document on the designation of an orphan drug under the provisions of the Article 77-2-5, Paragraph 1 of the Pharmaceutical Affairs Law * MHLW Notification No. 255 (July 16, 2003) - Document providing guideline on ethics in clinical research * MHLW Notification No. 256 (July 17, 2003) - Document on partial revision of medicinal products designated by the Minister of Health, Labor and Welfare based on the provisions of the Article 49, Paragraph 1 of the Pharmaceutical Affairs Law * MHLW Notification No. 265 (July 25, 2003) - Document specifying the range of medicinal products for reevaluation [quality reevaluation specifications] * MHLW Notification No. 276 (July 29, 2003) - Document partially revising the notified matters established by the Minister of the Health, Labor and Welfare in relations with the treatment-related regulations, and medicinal products-related regulations, and treatment standards - related regulations * MHLW Miscellaneous Communication (July 2, 2003) - Proceedings of the Second round table on the promotion of the pharmaceutical industry * MHLW Miscellaneous Communication (July 10, 2003) - Proceedings of the Third round table on the promotion of the pharmaceutical industry Director-General of the Pharmaceutical and Food Safety Bureau * PFSB Notification No. 0704006 (July 4, 2003) - About the international common names of medicinal products (reference) * PFSB Notification No. 0718005 (July 18, 2003) - About the standards of management of the organization and structure of the facilities for blood collection * PFSB Notification No. 0718009 (July 18, 2003) - As for the decision for "Stable supply of blood products in 2003 fiscal year" * PFSB Notification No. No. 0718011 (July 18, 2003) - About the instructions to the Japan Red Cross according to the enforcement of the standards of management of the organization and structure of the facilities for blood collection * PFSB Notification No. 0724008 (July 24, 2003) - Enforcement of the Law for Assuring a Stable Supply of Safe Blood and Blood Products * PFSB Notification No. 0725004 (July 25, 2003) - Scope of prescription medicinal products, which are required for submitting preliminary test results related to re-evaluation of quality (No. 52) * PFSB Notification No. 0729001 (July 29, 2003) - On the points of concerns related to the Enforcement of the Law for Assuring a Stable Supply of Safe Blood and Blood Products * PFSB Notification No. 0730008 (July 30, 2003) - About the recall of medicinal products Heads of the Pharmaceutical and Food Safety Bureau Divisions * PFSB, Evaluation and Licensing Division Notification No. 0701001 (July 1, 2003) - About abolishment of the designation of an orphan drug * PFSB, Evaluation and Licensing Division Notification No. 0701004 (July 1, 2003) - Partial revision of the requirements for preparing the data to be submitted with the application forms for the approval of manufacturing or import of new medicinal products (division imput 1 of 5) (main text) * PFSB, Evaluation and Licensing Division Notification No. 0701004 (July 1, 2003) - Partial revision of the requirements for preparing the data to be submitted with the application forms for the approval of manufacturing or import of new medicinal products (division imput 2 of 5) (attachment 1) * PFSB, Evaluation and Licensing Division Notification No. 0701004 (July 1, 2003) - Partial revision of the requirements for preparing the data to be submitted with the application forms for the approval of manufacturing or import of new medicinal products (division imput 3 of 5) (attachment 3) * PFSB, Evaluation and Licensing Division Notification No. 0701004 (July 1, 2003) - Partial revision of the requirements for preparing the data to be submitted with the application forms for the approval of manufacturing or import of new medicinal products (division imput 4 of 5) (attachment 4) * PFSB, Evaluation and Licensing Division Notification No. 0701004 (July 1, 2003) - Partial revision of the requirements for preparing the data to be submitted with the application forms for the approval of manufacturing or import of new medicinal products (division imput 5 of 5) (attachment 5) * PFSB, Evaluation and Licensing Division Notification No. 0701007 (July 1, 2003) - About holding a "Briefing session concerning the enforcement of the amended Pharmaceutical Affairs Law" * PFSB, Evaluation and Licensing Division Notification No. 0702003 (July 2, 2003) - Requirements for preparing the data to be submitted with the application forms for the approval of manufacturing or import of disinfectants for the soft contact lenses * PFSB, Evaluation and Licensing Division Notification No. 0702006 (July 2, 2003) - About an independent check etc. in relation to the disinfectants for the soft contact lenses * PFSB, Evaluation and Licensing Division Notification No. 0707001 (July 7, 2003) - About the guideline for bioequivalency testing of generic medicinal products for topical skin application * PFSB, Evaluation and Licensing Division Notification No. 0722001 (July 22, 2003) - About the scope of medicinal products, requiring a submission of preliminary test results related to re-evaluation of quality (26th Round) (quality re-evaluation of prescription medicinal products) * PFSB, Evaluation and Licensing Division Notification No. 0722008 (July 22, 2003) - About the collecting information on quality of prescription medicinal products (part 1) * PFSB, Evaluation and Licensing Division Notification No. 0722008 (July 22, 2003) - About the collecting information on quality of prescription medicinal products (part 2) * PFSB, Evaluation and Licensing Division Notification No. 0722008 (July 22, 2003) - About the collecting information on quality of prescription medicinal products (part 3) * PFSB, Evaluation and Licensing Division Notification No. 0722008 (July 22, 2003) - About the collecting information on quality of prescription medicinal products (part 4) * PFSB, Evaluation and Licensing Division Notification No. 0725003 (July 25, 2003) - About the public dissolution test affecting the quality reevaluation of the active ingredients of the prescription medicinal products (part 52) * PFSB, Evaluation and Licensing Division Notification No. 0728001 (July 28, 2003) - About the guideline on density measurement method for prescription or non-prescription pesticides in indoor air * PFSB, Evaluation and Licensing Division Notification No. 0729004 (July 29, 2003) - About the synthetic colorants that can be used in the medicinal products (MHLW Ordinance No. 30 of 1966) * PFSB, Evaluation and Licensing Division Office Working Information (July 2, 2003) - About the method for reviewing documents * PFSB, Evaluation and Licensing Division Office Working Information (July 3, 2003) - About the partial revision of the standards for biological preparations * PFSB, Evaluation and Licensing Division Office Working Information (July 3, 2003) - Q & A on guideline for bioequivalency testing of generic medicinal products for topical skin application * PFSB, Evaluation and Licensing Division Miscellaneous Communication (July 4, 2003) - Opinion on "Standards for conducting investigator-initiated clinical trials" (draft) and on "Ministerial Ordinance partially revising the Ministerial Ordinance about the standards of conducting of clinical trials of medicinal products" (draft) * PFSB, Evaluation and Licensing Division Office Working Information (July 15, 2003) - About the correction of the results of the reexamination of new medicinal products in 2003 (part 1) * PFSB, Evaluation and Licensing Division Office Working Information (July 15, 2003) - About the correction of the results of the reexamination of prescription medicinal products in 2003 (part 1) * PFSB, Evaluation and Licensing Division Office Working Information (July 17, 2003) - About the medicinal products approved as new medicinal products * PFSB, Evaluation and Licensing Division Office Working Information (July 22, 2003) - About the correction of the public dissolution test affecting the quality reevaluation of the active ingredients of the prescription medicinal products (draft) * PFSB, Evaluation and Licensing Division Office Working Information / Medical Equipment Section Notice (July 24, 2003) - About the soliciting opinions on the "Enforcement of the revision of the Pharmaceutical Affairs Law " [in relation to third-party certification] * PFSB, Evaluation and Licensing Division Office Working Information (July 28, 2003) - About an independent check etc. in relation to the disinfectants for the soft contact lenses * PFSB, Evaluation and Licensing Division Office Working Information (July 31, 2003) - About a correction of the partial amendment of the 1998 standards for pharmaceutical additives * PFSB, Evaluation and Licensing Division Office Working Information (July 31, 2003) - Progress report on the re-evaluation of the quality of medicinal products (quality re-evaluation of prescription medicinal products) (part 50) * PFSB, Evaluation and Licensing Division Notification No. 0709001 / PFSB, Safety Division Notification No. 0709003 (July 9, 2003) About an independent check etc. in relation to the conducting wires of the implantable cardioverter defibrillators * PFSB, Evaluation and Licensing Division Notification No. 0717001 / PFSB, Safety Division Notification No. 0717001 / PFSB, Compliance and Narcotics Division Notification No. 0717001 (July 17, 2003) Notice concerning the partial revision of the Pharmaceutical Affairs Law * PFSB, Evaluation and Licensing Division Notification No. 0725002 / PFSB, Blood and Blood Products Division - Notification No. 0725003 (July 25, 2003) Assurance of quality and safety in the application for approval of medicines and medical devices produced from raw materials originating from living organisms such as those from bovine origin * MHLW, PFSB, Evaluation and Licensing Division / Ministry of Economy, Trade and Industry, Manufacture Industrial Office, Chemical Substance Administration Division / Ministry of Environment, General Environment Policy Office, Environmental Health Department, General Planning and Policy Division - Miscellaneous Communication (July 22, 2003) - About the manufacture and import notification of new chemical entities * MHLW, PFSB, Evaluation and Licensing Division / Ministry of Economy, Trade and Industry, Manufacture Industrial Office, Chemical Substance Administration Division / Ministry of Environment, General Environment Policy Office, Environmental Health Department, General Planning and Policy Division - Miscellaneous Communication (July 22, 2003) - About the testing methods and examination standards concerning the examination of the relevant characteristics of specified chemical substances * MHLW, PFSB, Evaluation and Licensing Division / Ministry of Economy, Trade and Industry, Manufacture Industrial Office, Chemical Substance Administration Division / Ministry of Environment, General Environment Policy Office, Environmental Health Department, General Planning and Policy Division - Miscellaneous Communication (July 22, 2003) - About the partial amendment of the "Method for recording of the content of the document that should become reference at the notification of the new chemical entity in an electronic medium and its submission" * PFSB, Safety Division Notification No. 0702001 / PFSB, Blood and Blood Products Division No. 0702001 (July 2, 2003) - Q & A concerning the explanations to be given to subjects in relation with the medicinal products originating from living organisms and the specifications of the medicinal products originating from living organisms * PFSB, Safety Division Miscellaneous Communication (July 8, 2003) - First report for 2003 of the Study Committee on the measures in relation with the Bovine Spongiform Encephalitis (BSE) * PFSB, Safety Division Notification No. 0709001 (July 9, 2003) - Revisions of the cautions for use of medicinal products * PFSB, Safety Division Office Working Communication (July 9, 2003) - Revisions of the cautions for use of medicinal products * PFSB, Safety Division Office Working Communication (July 9, 2003) - Request for cooperation prior the filling of the electronic form reports for adverse event reporting * PFSB, Safety Division Office Working Communication / PFSB, Evaluation and Licensing Division Office Working Information (July 25, 2003) - About the results of the testing of EDI (Electronic Data Interchange) tools in the information reporting system for adverse events and use of free tools in the information reporting system for adverse events * PFSB, Safety Division Notification No. 0730001 (July 30, 2003) - About the changes - affecting the reporting method, in the recording and keeping the records related to the products originating from living organisms * PFSB, Safety Division Notification No. 0730006, and PFSB, Compliance and Narcotics Division Notification No. 0730003, and PFSB, Blood and Blood Products Division Notification No. 0730003 (July 30, 2003) - About the announcement of the information from the Japanese Red Cross Society regarding the retroactive investigations of medical institutions * PFSB, Safety Division Notification No. 0730005, and PFSB, Compliance and Narcotics Division Notification No. 0730002, and PFSB, Blood and Blood Products Division Notification No. 0730002 (July 30, 2003) - About the announcement of the information from the Japanese Red Cross Society regarding the retroactive investigations of medical institutions * PFSB, Compliance and Narcotics Division Notification No. 0710001 (July 10, 2003) - About the import and sales of medical devices different than those submitted for approval * PFSB, Compliance and Narcotics Division - Miscellaneous Communication (July 10, 2003) - About the administrative penalty to a trader violating the Pharmaceutical Affairs Law * PFSB, Blood and Blood Products Division Office Working Information (July 3, 2003) - Information on the establishment of an "Information page of blood business" * PFSB, Blood and Blood Products Division Miscellaneous Communication (July 15, 2003) - About the dispatch of an opinion on Enforcement Regulations of the Law for Assuring a Stable Supply of Safe Blood and Blood Products (a proposal) * PFSB, Blood and Blood Products Division Miscellaneous Communication (July 29, 2003) - About publication of an answer from the Japanese Red Cross Society for a report enquiry of the Minister of Health, Labor and Welfare (June 16, 2003) (a report) * PFSB, General Affairs Division / PFSB, Evaluation and Licensing Division / PFSB, Safety Division / PFSB, Compliance and Narcotics Division - Miscellaneous Communication (July 24, 2003) Soliciting opinions on the "Enforcement of the revision of the Pharmaceutical Affairs Law (proposal)" [in relation to third-party certification] * PFSB, Food Safety Department - Miscellaneous Communication (July 1, 2003) - Personnel changes (as of July 1, 2003) * PFSB, Food Safety Department - Miscellaneous Communication (July 15, 2003) - Sixth meeting of the Committee on the conditions of the optimal environment affecting the "Healthy Food" system * PFSB, Food Safety Department - Miscellaneous Communication (July 31, 2003) - Medicines and medical devices safety information [concerning sodium chloride, potassium chloride, magnesium chloride, calcium chloride, and sodium bicarbonate, 5 products] Other Bureaus of the MHLW / Other related organizations * Health Policy Bureau Notification No. 0724001 (July 24, 2003) About the enforcement of the survey on the actual conditions of the pharmaceuticals/medical devices industry (manufacturing) (at closing the accounts in 2002 fiscal year) * Health Policy Bureau Notification No. 0730009 (July 30, 2003) Announcement in relation with the enforcement of the guideline on ethics in clinical research * Health Policy Bureau Miscellaneous Communication (July 1, 2003) Personnel changes (as of July 1, 2003) * Health Policy Bureau / Administrative Division - Miscellaneous Communication (July 29, 2003) Proceeding of the First meeting of the Accident Reporting Range Examination Committee * Health Policy Bureau / Economics Affairs Division Notification No. 0704001 and 070400 2 (July 4, 2003) About the newly published "Price standards for medicines prescribed under the Health Insurance System Medicinal Products Codes" for medicinal products according to the Price standards for medicines prescribed under the Health Insurance System * Health Policy Bureau / Economics Affairs Division Notification, Price of Medicinal Products Section Office Working Information (July 4, 2003) About changes in the Price standards for medicines prescribed under the Health Insurance System * Health Policy Bureau / Economics Affairs Division Miscellaneous Communication (July 3, 2003) About the published price standards for medicines prescribed under the Health Insurance System for generic medicinal products * Health Policy Bureau / Economics Affairs Division Office Working Information (July 17, 2003) Survey of the medicinal products manufacturing (import) expenditures classified by all prefectures (as of January 2003) * Health Policy Bureau / Economics Affairs Division Office Working Information (July 24, 2003) About the investigation concerning the tariff reform in 2004 fiscal year (a request) * Health Services Bureau, Tuberculosis and Infectious Diseases Control Division Notification No. 0701002 (July 1, 2003) About the response by the quarantine stations to the Severe Acute Respiratory Syndrome (SARS) * Health Services Bureau, Tuberculosis and Infectious Diseases Control Division Notification No. 0704002 (July 4, 2003) About the response by the quarantine stations to the Severe Acute Respiratory Syndrome (SARS) * Health Services Bureau, Tuberculosis and Infectious Diseases Control Division Notification No. 0714001 (July 14, 2003) On the criteria for distinguishing the patients with Severe Acute Respiratory Syndrome (SARS) from similar conditions * Health Services Bureau Notification No. 0714007 (July 14, 2003) On the enforcement of the Ministerial Ordinance on prevention of infectious disease in relation with the enforcement of the Cabinet Order on designation of the Severe Acute Respiratory Syndrome (SARS) as a specified infection under the Article 6, Paragraph 6 of the Law Concerning the Prevention of Infections and Medical Care for Patients of Infections * Health Services Bureau Notification No. 0714007 / PFSB Notification No. 0714001 (July 14, 2003) On the enforcement of the Ministerial Ordinance on the revision of the Enforcement Regulations of the Quarantine Act in relation to the Cabinet Order on the designation of the Severe Acute Respiratory Syndrome (SARS) as an infectious disease under the Article 34 of the Quarantine Act * Health Services Bureau, Tuberculosis and Infectious Diseases Control Division Notification No. 0722001 / PFSB, Food Safety Department、Planning Division, Quarantine Station Management Section Notification No. 0722001 (July 22, 2003) Enforcement of the Quarantine Act in relation with the Severe Acute Respiratory Syndrome (SARS) * Health Insurance Bureau, Medical Economics Division Notification No. 0606001 (July 4, 2003) About the points of concerns regarding the partial revision of the prices of the medicinal products in use (Price standards for medicines prescribed under the Health Insurance System) III. REGULATORY DOCUMENTS FROM OTHER AUTHORITIES Issuer - Date - Title * Central Social Insurance Medical Council - Miscellaneous Communication (July 30, 2003) - Proceedings of the 35th General Meeting of the Central Social Insurance Medical Council * Central Social Insurance Medical Council - Miscellaneous Communication (July 30, 2003) - Outline of the new technologies used in the advanced medical treatment * Central Social Insurance Medical Council - Miscellaneous Communication (July 30, 2003) - Approval of advanced medical technology * Central Social Insurance Medical Council - Miscellaneous Communication (July 30, 2003) - New insurance application * Central Social Insurance Medical Council - Miscellaneous Communication (July 31, 2003) - Medical Treatment Fees Special organization / Medical Technology Assessment Subcommittee (the 1st time gathering) Communications The highest level administrative documents issued by various authorities CSIMC Central Social Insurance Medical Council Ministries Ministry of Economy, Trade and Industry REGULATORY DOCUMENTS FROM OTHER AUTHORITIES (CONT.) * Special Committee on Drug Prices of the Central Social Insurance Medical Council - Miscellaneous Communication (July 23, 2003) - Proceedings of the 14th Meeting of the Special Committee on Drug Prices of the Central Social Insurance Medical Council * Special Committee on Drug Prices of the Central Social Insurance Medical Council - Miscellaneous Communication (July 23, 2003) - Guideline on the Evidence Based Medicine (EBM) techniques for the medical examination and treatment * Special Committee on Drug Prices of the Central Social Insurance Medical Council - Miscellaneous Communication (July 23, 2003) - Toward the Increased International Competitiveness of the Japanese Pharmaceutical Industry in the Bio-century * Special Committee on Drug Prices of the Central Social Insurance Medical Council - Miscellaneous Communication (July 23, 2003) - Progress report on the quality reevaluation * Special Committee on Drug Prices of the Central Social Insurance Medical Council - Miscellaneous Communication (July 23, 2003) - Basic plan on the matters that will be examined in relation with the medical charges calculation standards in the future * Special Subcommittee on the Basic Problems of the Medical Treatment Fees of the Central Social Insurance Medical Council - Miscellaneous Communication (July 9, 2003) - Proceeding of the 31st Meeting of the Central Social Insurance Medical Council Special Subcommittee on the Basic Problems of the Medical Treatment Fees * Special Subcommittee on the Basic Problems of the Medical Treatment Fees of the Central Social Insurance Medical Council - Miscellaneous Communication (July 9, 2003) - Maintenance of the environment for generic drugs * Special Subcommittee on the Basic Problems of the Medical Treatment Fees of the Central Social Insurance Medical Council - Miscellaneous Communication (July 9, 2003) - About the current state of the odontology departments medical treatment expenses etc. * Special Subcommittee on the Basic Problems of the Medical Treatment Fees of the Central Social Insurance Medical Council - Miscellaneous Communication (July 9, 2003) - About the dental treatment fees * Special Subcommittee on the Basic Problems of the Medical Treatment Fees of the Central Social Insurance Medical Council - Miscellaneous Communication (July 9, 2003) - Data about the dispensing fees * Special Subcommittee on the Basic Problems of the Medical Treatment Fees of the Central Social Insurance Medical Council - Miscellaneous Communication (July 9, 2003) - On the present situation of the compounded drug expenses in healthcare cost, and pharmacies accepting health insurance * Special Subcommittee on the Basic Problems of the Medical Treatment Fees of the Central Social Insurance Medical Council - Miscellaneous Communication (July 9, 2003) - About the present condition of the partial liver transplant from a living donor in our country * Special Subcommittee on the Basic Problems of the Medical Treatment Fees of the Central Social Insurance Medical Council - Miscellaneous Communication (July 16, 2003) - Proceeding of the 32nd Meeting of the Central Social Insurance Medical Council Special Subcommittee on the Basic Problems of the Medical Treatment Fees * Special Subcommittee on the Basic Problems of the Medical Treatment Fees of the Central Social Insurance Medical Council - Miscellaneous Communication (July 16, 2003) - About the demographic division of the medical services in the healthcare plans * Special Subcommittee on the Basic Problems of the Medical Treatment Fees of the Central Social Insurance Medical Council - Miscellaneous Communication (July 16, 2003) - Evaluation of initial medical examination and a primary physician function * Special Subcommittee on the Basic Problems of the Medical Treatment Fees of the Central Social Insurance Medical Council - Miscellaneous Communication (July 16, 2003) - About the new doctors clinical training system * Special Subcommittee on the Basic Problems of the Medical Treatment Fees of the Central Social Insurance Medical Council - Miscellaneous Communication (July 16, 2003) - About the emergency health care system * Special Subcommittee on the Basic Problems of the Medical Treatment Fees of the Central Social Insurance Medical Council - Miscellaneous Communication (July 16, 2003) - About the infant medical treatment * Special Subcommittee on the Basic Problems of the Medical Treatment Fees of the Central Social Insurance Medical Council - Miscellaneous Communication (July 23, 2003) - Proceeding of the 33rd Meeting of the Central Social Insurance Medical Council Special Subcommittee on the Basic Problems of the Medical Treatment Fees * Special Subcommittee on the Basic Problems of the Medical Treatment Fees of the Central Social Insurance Medical Council - Miscellaneous Communication (July 23, 2003) - Concerning the adaptation of unapproved substances of foreign origin as effective ingredients as published in the "Guideline for rational use of anti-cancer medicines" (draft) * Special Subcommittee on the Basic Problems of the Medical Treatment Fees of the Central Social Insurance Medical Council - Miscellaneous Communication (July 23, 2003) - About the present situation with medicinal products adapted for external use * Special Subcommittee on the Basic Problems of the Medical Treatment Fees of the Central Social Insurance Medical Council - Miscellaneous Communication (July 23, 2003) - About the handling of anti-cancer drug in the M-VAC treatment * Special Subcommittee on the Basic Problems of the Medical Treatment Fees of the Central Social Insurance Medical Council - Miscellaneous Communication (July 23, 2003) - Changes in the home medical treatment * Special Subcommittee on the Basic Problems of the Medical Treatment Fees of the Central Social Insurance Medical Council - Miscellaneous Communication (July 23, 2003) - Evaluation of initial medical examination and a primary physician function * Special Subcommittee on the Basic Problems of the Medical Treatment Fees of the Central Social Insurance Medical Council - Miscellaneous Communication (July 30, 2003) - About the transition of the medical treatment fees system * Special Subcommittee on the Basic Problems of the Medical Treatment Fees of the Central Social Insurance Medical Council - Miscellaneous Communication (July 30, 2003) - Evaluation on medical treatment fees for elderly * Special Subcommittee on the Basic Problems of the Medical Treatment Fees of the Central Social Insurance Medical Council - Miscellaneous Communication (July 30, 2003) - On the promotion of IT in the medical treatment field * Special Subcommittee on the Basic Problems of the Medical Treatment Fees of the Central Social Insurance Medical Council - Miscellaneous Communication (July 30, 2003) - On the indications for insurance application in the medical examination and treatment acts * Special Subcommittee on the Basic Problems of the Medical Treatment Fees of the Central Social Insurance Medical Council - Miscellaneous Communication (July 30, 2003) - Proceeding of the 34th Meeting of the Central Social Insurance Medical Council Special Subcommittee on the Basic Problems of the Medical Treatment Fees * Special Sectional Committee on the Insurance of the Medical Care Materials of the Central Social Insurance Medical Council - Miscellaneous Communication (July 16, 2003) - Reference data * Special Sectional Committee on the Insurance of the Medical Care Materials of the Central Social Insurance Medical Council - Miscellaneous Communication (July 16, 2003) - Outline of proceedings (draft) * Special Sectional Committee on the Insurance of the Medical Care Materials of the Central Social Insurance Medical Council - Miscellaneous Communication (July 16, 2003) - Proceeding of the 12th Meeting of the Special Sectional Committee on the Insurance of the Medical Care Materials * Minister of Agriculture, Forestry and Fisheries Notification No. 1034 (July 14, 2003) - Document defining the products originating from living organisms * Minister of Agriculture, Forestry and Fisheries Ordinance No. 76 (July 15, 2003) - Ministerial Ordinance which revises some regulatory rules, such as on drugs for animals * Minister of Agriculture, Forestry and Fisheries Notification No. 1091 (July 28, 2003) - Document defining the standards for products originating from living organisms * Minister of Agriculture, Forestry and Fisheries Ordinance No. 78 (July 30, 2003) - Ministerial Ordinance partially revising the Ministerial Ordinance on the standards for implementation of clinical trials for drugs for animals (Revision) * Organization for Pharmaceutical Safety and Research, Guidance Division - Miscellaneous Communication (July 23, 2003) - Q &A on consultations on clinical trials * National Federation of Health Insurance Societies - Miscellaneous Communication (July 9, 2003) - 2002 fiscal year health insurance comprehensive policy investigation / a study grant - An investigation study industry report on the rationalization of the medical expenses by the separation of dispensing and prescribing practices (excerpts) V. DOCUMENTS FROM INDUSTRY GROUPS Issuer - Date - Title * FPMAJ Rapid Communication No. 457 (July 22, 2003) - Announcement about the change of the venue of the "Pharmaceuticals Electronic Standards Study Group Symposium" * FPMAJ Rapid Communication No. 470 (July 29, 2003) - About the participation application for prescription medicines reevaluation on the basis of the Pharmaceutical Affairs Law (Report 52) * FPMAJ Rapid Communication No. 473 (July 30, 2003) About an opinion for a revision of the medicines classification list (draft) (submission deadline August 19, FPMAJ) * FPMAJ Rapid Communication No. 475 (July 30, 2003) About reporting on the basis of the Article 77, Paragraph 4, Item 2, sub-item 2 of the Pharmaceutical Affairs Law of the adverse events/infectious diseases to the companies by the healthcare personnel concerned * FPMAJ Rapid Communication No. 482 (July 31, 2003) A dispatch of the information related to the agreement between FPMAJ and JPWA regarding the supply and preservation of information and records Communications FPMAJ Federation of Pharmaceutical Manufacturers' Associations of Japan JPMA Japan Pharmaceutical Manufacturers Association JPWA Japan Pharmaceutical Wholesalers Association OPMA Osaka Pharmaceutical Manufacturers Association JMA Japan Medical Association JPA Japan Pharmaceutical Association The highest level administrative documents issued by various industry associations and trade groups, and professional organizations DOCUMENTS FROM INDUSTRY GROUPS (CONT.) * FPMAJ Fifth Study Group of the Project for Revision of the Pharmaceutical Affairs Law - Miscellaneous Communication (July 31, 2003) - On the change of the notification on clinical trial plan * JPMA Drug Evaluation Committee Notification No. 552 (July 2, 2003) - Guidance on the "Pharmaceuticals Electronic Standards Study Group Symposium" * OPMA Notice No. 203 (July 1, 2003) - About holding of the state examination for general surveyors of the additional classes in the fiscal 2003 year * OPMA Miscellaneous Communication (July 17, 2003) - Reference information / new medicines approval (the Office Working Information dated July 17, 2003) about medicinal products approved as new medicinal products * JPA Miscellaneous Communication (July 9, 2003) - Health insurance pharmacy management survey report for 2002 fiscal year V. MISCELLANEOUS Issuer - Date - Title * National Printing Bureau (Independent Administrative Agency) - Miscellaneous Communication (July 1, 2003) - Public announcement of the successful bidders of medicinal products * National Printing Bureau (Independent Administrative Agency) - Miscellaneous Communication (July 11, 2003, 2003) - Public announcement of the successful bidders of medicinal products * Drug Products Liability Center - Miscellaneous Communication (July 10, 2003) - Drug Products Liability Center FAX communication No. 87 * Drug Products Liability Center - Miscellaneous Communication (July 28, 2003) - Report of the Drug Products Liability Center for the April-June quarter of the 2003 fiscal year Communications Organizations National Printing Bureau Drug Products Liability Center The administrative documents issued by various organizations Note concerning the translation of the titles All original documents issued by the Japanese Government, other authorities and industry group are issued only in Japanese, including their titles, table of contents and texts. Translation of the titles in English is provided here solely by the Jouhou Koukai Services. While utmost care has been taken both linguistically and organizationally to reflect into the English translation the language, abbreviations, professional jargon, style and conventions used in the original texts, no claims either expressed or implied are made for completeness and correctness. Some of the conventions used originate from legacy documents earlier translated to English under the supervision of the MHLW. The Japanese Government does not provide authorized (officially sanctioned) translations of its documents. The translations here are tentative. In a case of legal dispute, the original texts in Japanese will prevail. The authoring, translation, formatting, indexing and hyperlinking of the text are copyrights of the Jouhou Koukai Services LLC Worldwide Copyright (c) 2001-2003 by JKS LLC Reproduction in whole or part without permission is forbidden. www.jouhoukoukai.com Note: See also document 7_D_K003 in JKS Document Store. Note: Both the English and the Japanese terms for EBM are used in the Japanese title of the document. Japanese Pharmaceutical Affairs Authorities Regulatory Documents July 2003 Copyright (c) 2001-2003 by JKS LLC - 2 - Japanese Pharmaceutical Affairs Authorities Regulatory Documents July 2003 Copyright (c) 2001-2003 by JKS LLC - - 24 -