Medical Devices Quaterly April-June 2003 Single User License - TABLE OF CONTENTS HOW TO USE THIS DOCUMENT I. APRIL 2003 II. MAY 2003 III. JUNE 2003 IV. GLOSSARY V. ABBREVIATIONS Note concerning the translation of the titles HOW TO USE THIS DOCUMENT 　　　The list herein contains the description of the documents related to the category of medical devices issued by the Japanese regulatory authorities. As illustrated by the example below, the description of each document includes the date of issue, the issuing authority (full name and abbreviation), the document category or type (see Glossary section), the documents ID number, and the full title in English. 　　　Any further enquiries regarding the documents, their contents and the lists should be addressed to the Regulatory Group of Jouhou Koukai Services at regulatory@jouhoukoukai.com. Example * May 21, 2003 - Pharmaceutical and Food Safety Bureau (PFSB) Notification No. 0520001 About the products of animal origin, designation of specific products of animal origin and the establishment of standards for the products of animal origin I. APRIL 2003 * April 1, 2003 - Ministry of Health, Labor and Welfare MHLW Ordinance No. 75 Ministerial Ordinance partially revising the Ministerial ordinance on the MHLW organizational regulations * April 14, 2003 - Pharmaceutical and Food Safety Bureau PFSB Notification No. 0414004 / PFSB Notification No. 0414005 On the quality and safety assurance of the medicines and medical devices produced by using materials from bovine or human origin * April 25, 2003 - Pharmaceutical and Food Safety Bureau PFSB Notification No. 0425005 Guidance for the enterprises not responded to the Notification No. 1314 of December 26, 2000 of the Director-General of Pharmaceutical and Food Safety Bureau, Ministry of Health and Welfare * April 25, 2003 - Health Policy Bureau, Research and Development Division Office Working Information About the "National 3-year Clinical Trials Revitalization Plan" * May 30, 2003 - MHLW, Pharmaceutical and Food Safety Bureau Miscellaneous Communication Pharmaceuticals and Medical Devices Safety Information Bulletin No. 189 II. MAY 2003 * May 1, 2003 - Ministry of Health, Labor and Welfare, Health Policy Bureau, Research and Development Division / Ministry of Education, Culture, Sports, Science and Technology, Higher Education Bureau, Medical Education Division Miscellaneous Communication About the "National 3-year Clinical Trials Revitalization Plan" * May 1, 2003 - MHLW, PFSB, Evaluation and Licensing Division / Safety Division - Office Working Office Working Information About the safety measures for medicinal products and medical devices in relation with the Severe Acute Respiratory Syndrome, SARS * May 13, 2003 - Ministry of Health, Labor and Welfare, Pharmaceutical and Food Safety Bureau, Evaluation and Licensing Division Office Working Information About the review of the applications for the Manufacture and Import Approval of new medicinal products * May 15, 2003 - Ministry of Health, Labor and Welfare MHLW Ordinance No. 89 Ministerial ordinance revising partially the Enforcement Regulations of the Pharmaceutical Affairs Law * May 15, 2003 - Pharmaceutical and Food Safety Bureau PFSB Notification No. 0515002 About the special reason to use X-ray devices in the radiation examination room where an X-ray examination room is not provided and the appropriate protective measures * May 15, 2003 - Pharmaceutical and Food Safety Bureau Notification No. 0515005 Items, which should be included in the package leaflet of products originating for living organisms * May 15, 2003 - Pharmaceutical and Food Safety Bureau Notification No. 0515008 On the periodic report system for infectious contamination of medicinal products originating for living organisms * May 15, 2003 - Pharmaceutical and Food Safety Bureau Notification No. 05150011/ Notification No. 05150012 On the explanation to the investigation subjects about the effect of the use of certain products of animal origin and on the recording and keeping the record for the use of certain products originating for living organisms * May 15, 2003 - Pharmaceutical and Food Safety Bureau Notification No. 05150014 About the enforcement of legislation for establishment of reporting by the medical institutions of side effects, infections and complications related to medicines and medical devices * May 15, 2003 - Pharmaceutical and Food Safety Bureau Notification No. 0515017 [Corrigendum] Partial revision of the Pharmaceutical Affairs Law and Enforcement Regulations of the Pharmaceutical Affairs Law in relation to the rule for blood donation and blood collection [Correction of the information printed in the text] * May 15, 2003 - Ministry of Health, Labor and Welfare MHLW Notification No. 206 Amendment of the list of the medical devices specified by the Minister of Health, Labor and Welfare based on the Article 15, Paragraph 2, Item 2 of the Enforcement Regulations of the Pharmaceutical Affairs Law * May 20, 2003 - Ministry of Health, Labor and Welfare MHLW Notification No. 209 A policy document defining the animal products and specified by the Minister of Health, Labor and Welfare products of animal origin * May 20, 2003 - Ministry of Health, Labor and Welfare MHLW Notification No. 210 A policy document defining the standards for materials originating from living organisms * May 20, 2003 - Ministry of Health, Labor and Welfare MHLW Notification No. 212 Partial revision of the medical devices specified under the Article 63, Paragraph 2 of the Pharmaceutical Affairs Law * May 20, 2003 - Ministry of Health, Labor and Welfare MHLW Ordinance No. 92 Partial revision of the ministerial ordinance on the pharmacy manufacturing equipment * May 20, 2003 - Ministry of Health, Labor and Welfare MHLW Ordinance No. 93 Amendment of the Article 1, Paragraph 2, Item 2(1) of the Enforcement Regulations of the Pharmaceutical Affairs Law for manufacturing of a product in two or more factories in relation with the revised ministerial ordinance on GMP * May 20, 2003 - Ministry of Health, Labor and Welfare MHLW Ordinance No. 94 Ministerial ordinance revising manufacturing and quality controls for medical devices * May 20, 2003 - Ministry of Health, Labor and Welfare MHLW Ordinance No. 96 Ministerial ordinance revising manufacturing and quality controls for imported medical devices * May 20, 2003 - Pharmaceutical and Food Safety Bureau (PFSB) Notification No. 0520001 About the products of animal origin, designation of specific products of animal origin and the establishment of standards for the products of animal origin * May 20, 2003 - PFSB, Evaluation and Licensing Division / PFSB, Safety Division / PFSB, Compliance and Narcotics Division / PFSB, Blood and Blood Products Division Notification No. 0520001, 0520001, 0520001, 0520001 About the transferring of the office responsibilities, etc. in relation with the partial revision of the Enforcement Regulations of the Pharmaceutical Affairs Law * May 20, 2003 - PFSB, Evaluation and Licensing Division Office Working Information Partial revision of the Pharmaceutical Affairs Law and Enforcement Regulations of the Pharmaceutical Affairs Law in relation to the rule for blood donation and blood collection * May 20, 2003 - Pharmaceutical and Food Safety Bureau (PFSB) Notification No. 0520004 Partial revision of the ministerial ordinance on manufacture and quality control of medicines and quasi-medicines * May 20, 2003 - PFSB, Safety Division Notification No. 052000１ About independent check of medical endoscopes, etc. * May 20, 2003 - PFSB, Safety Division Notification No. 0520004 About the statements in the package inserts of products originating from living organisms * May 22, 2003 - Pharmaceutical and Food Safety Bureau (PFSB) Notification No. 0522002 On the quality and safety assurance of the medicines and medical devices produced by using products from animal origin from Canadian cattle * May 23, 2003 - Prime Minister (Cabinet) Law No. 48 Food Safety Basic Law * May 26, 2003 -PFSB, Safety Division Notification No. 0526001 About independent check of combined use of medicinal products and medical devices made from polycarbonate * May 27, 2003 - MHLW, Pharmaceutical and Food Safety Bureau PFSB Notification No. 0529005 Conclusions in relation to the notice of the Director-General of the PFSB regarding the PMSB/ELD Notification No. 1314 (dated December 26, 2000) to the businesses which have not yet responded * May 30, 2003 - MHLW, Pharmaceutical and Food Safety Bureau Miscellaneous Communication Pharmaceuticals and Medical Devices Safety Information Bulletin No. 189 * May 30, 2003 - MHLW, Health Policy Bureau / Economics Affairs Division Miscellaneous Communication Miscellaneous Communication About the situation and the progress of the pharmaceutical industrial vision "Action plan for global competitiveness" Other relevant documents * May 27, 2003 - Federation of Pharmaceutical Manufacturers' Associations of Japan (FPMAJ) Rapid Communication No. 320 On the quality and safety assurance of the medicines and medical devices produced by using products from animal origin from Canadian cattle * May 30, 2003 - Ministry of Economy, Trade and Industry Miscellaneous Communication Official announcement of report on the medical equipment industrial round-table conference III. JUNE 2003 * June 5, 2003 - PFSB, Evaluation and Licensing Division Notification No. 0605001 Assurance of quality and safety in the application for approval of pharmaceutical products and medical devices produced from raw materials from bovine origin from Canada * June 11, 2003 - Prime Minister (Cabinet) Law No. 73 Law concerning the implementation by the Ministry of Agriculture, Forestry and Fisheries in a connection with the of Food Sanitation Law * June 12, 2003 - PFSB, Evaluation and Licensing Division Notification No. 0612004 Partial revision of the "Handling of the reports for the clinical trials of medicinal products" * June 12, 2003 - Health Policy Bureau Notification No. 0612004 About the enforcement of Ministerial Ordinance concerning the clinical training specified under the provisions of the Article 16-2, Paragraph 1 of the Medical Practitioners' Law * June 12, 2003 - PFSB, Evaluation and Licensing Division / PFSB, Safety Division / PFSB, Blood and Blood Products Division Office Working Information About the public announcement on the revisions of the Pharmaceutical Affairs Law and the blood collection regulations in regard to the "Availability of more efficient and safer use of the pharmaceuticals and medical devices in the medical treatment" * June 14, 2003 - PFSB, Compliance and Narcotics Division Notification No. 0614083 About the instruction for recall of medical devices by the Japan Medtronic Co. (valve of swine origin) * June 17, 2003 - PFSB, General Affairs Division / PFSB, Evaluation and Licensing Division / PFSB, Safety Division / PFSB, Compliance and Narcotics Division Miscellaneous Communication Dispatch of opinions on the "Enforcement of the revision of the Pharmaceutical Affairs Law (proposal)" * June 17, 2003 - PFSB, Evaluation and Licensing Division / PFSB, Safety Division / PFSB, Compliance and Narcotics Division Miscellaneous Communication Soliciting opinions on the "Enforcement of the revision of the Pharmaceutical Affairs Law (proposal)" [to be enforced in 2005] * June 19, 2003 - Prime Minister (Cabinet) Law No. 97 Law on preservation of the diversity of the animals by regulation of the use of transgenic animals * June 2０, 2003 - PFSB, Safety Division / PFSB, Compliance and Narcotics Division PFSB, SD Notification No. 0620002 / PFSB, CND Notification No. 0620004 About the thoroughness of the quality control of thicket type cardiac pacemakers etc. and the safety control after marketing * June 24, 2003 - Health Policy Bureau Notification No. 0624001 About the enforcement of the survey on the actual conditions of the pharmaceuticals/medical devices industry (manufacturing/wholesale business) (at closing the accounts in 2002 fiscal year) * June 24, 2003 - HPB, Economics Affairs Division / PFSB, General Affairs Division Notification No. 0624001 / Notification No. 0624002 About the USA demand for deregulation (July 31 deadline for submission of opinions to the Japan Self-medication Industry Association ) * June 26, 2003 - Pharmaceutical and Food Safety Bureau PFSB Miscellaneous Communication Pharmaceuticals and Medical Devices Safety Information Bulletin No.190 * June 30, 2003 - PFSB, Safety Division Notification / PFSB, Evaluation and Licensing Division Notification No. 0630004 / Notification No. 0630006 About the implementation of electronic reports in adverse events reporting (Part 1) Other relevant documents * June 12, 2003 - Secretariat of the Patent System Subcommittee to the Intellectual Property Policy Sectional Meeting of the Japan Patent Office Industry Structure Council Miscellaneous Communication About the handling of the Patent Law concerning healthcare related laws * June 19, 2003 - Federation of Pharmaceutical Manufacturers' Associations of Japan, FPMAJ Rapid Communication No. 388 Q&A documents of the FPMAJ regarding the Notice "Raw materials from bovine or human origin used for production of prescription medicines and medical devices, and assurance of the quality and safety" IV. GLOSSARY Term Definition Yakiji-hou Pharmaceutical Affairs Law (PAL) The Pharmaceutical Affairs Law, PAL (Law No. 145 of 1960) is the key legislative document regulating the research, development, review, approval, manufacture, import, sales, distribution, supply, marketing, advertising, pricing, reimbursement, reexamination, reevaluation, safety, efficacy, quality, fees, violations, penalties and other related maters collectively described as pharmaceutical affairs. The PAL is through the Enforcement Ordinance of the PAL and by the Enforcement Regulations of the PAL. Iyakuhin Medicinal products Medicinal products are all products regulated by the Pharmaceutical Affairs Law and categorized into four regulatory categories: medicines (prescription and non-prescription), quasi-medicines (quasi-drugs), cosmetics and medical devices. [In some older translations from Japanese the term, iyakuhin is given as "drugs, etc."] "Medicines agency" Although there is a functional "Medicines agency" in Japan, no single administrative body exists to resemble FDA, or other national agencies. The "Medicines agency" functions as a collaboration between several Governmental entities, headed by the Pharmaceutical and Food Safety Bureau of the Ministry of Health, Labor and Welfare, and including the Pharmaceutical Affairs Divisions of the Health Bureaus of each Prefectural Government, the Pharmaceuticals and Medical Devices Evaluation Center (part of the National Institutes of Health Sciences, NIHS), and the Organization for Pharmaceutical Safety and Research (OPSR). Kyoka License License to manufacture or import medicinal products under the Pharmaceutical Affairs Law. Kyoka licenses must be obtained for each production unit or business office. Depending on the category of the medicinal products, the Kyoka licenses are granted either by the Minister of Health, Labor and welfare, or by the Governor of the prefecture where the application for Kyoka is submitted. In effect, to be marketed each medicinal product must have both Kyoka license and Shonin approval. Shonin Approval Approval to manufacture or import medicinal products under the Pharmaceutical Affairs Law. Shonin approvals must be obtained for each production unit or business office. Depending on the category of the medicinal products, the Shonin approvals are granted either by the Minister of Health, Labor and welfare, or by the Governor of the prefecture where the application for Shonin is submitted. In effect, to be marketed each medicinal product must have both Kyoka license and Shonin approval. Kouseirodousho The name in Japanese of the Ministry of Health, Labor and Welfare, MHLW. Sometimes referred also as "Kourosho". Iyakuhin Kiko The Organization for Pharmaceutical Safety and Research (OPSR) - an administrative body within the jurisdiction of the MHLW. Also commonly known in English as "The Drug Organization", or "Kiko". (Previously the formal name of the organization was given in English as The Organization for Drug Adverse Drug Reaction Relief, Research & Development Promotion and Product Review) Shiunsa-senta The Pharmaceuticals and Medical Devices Evaluation Center, PMEDEC - part of the National Institutes of Health Sciences, NIHS. Chuikyo The Central Social Insurance Medical Affairs Council, CSIMAC - an administrative body within the jurisdiction of the MHLW. Document category Definition Law Enforced legislation. Laws are identified by number and the year of original enactment. Compliance is obligatory. Order The highest-level administrative decrees issued by the Cabinet - the executive branch of the Government of Japan. Orders are identified by number and date. Compliance is obligatory. Ministerial Ordinance The highest level administrative decrees issued only by the Cabinet or the individual ministers. Aside from the Minister of Health, Labor and Welfare, ordinances relevant to healthcare and pharmaceutical affairs could be issued also by the Minister of Economy, Trade and Industry, the Minister of Agriculture, Forestry and Fisheries, and the Minister of Education, Culture, Sports, Science and Technology. Ordinances are identified by number and date. Compliance is obligatory. Ministerial Notification Issued by the MHLW and dealing with various practical issues other than those covered by the Ministerial Ordinances. Ministerial Notifications are identified by number and date. Compliance is obligatory. Notification Issued by Director-General of the Pharmaceutical and Food Safety Bureau and other Bureaus of the MHLW, and by the Heads of the subordinated divisions. Notifications are identified by number and date. Compliance is obligatory. Office Working Information Translated also as "Notices" or "Public Announcements", the documents in this category cover similar matters as of the Notifications, without the obligatory compliance. Miscellaneous Communication Include all other documents issued for informational, reporting, soliciting opinions and other similar purposes. Identified only by date. Others Other authorities, industry groups, and various bodies may also issue relevant documents categorized in similar or differing formats. Identified only by date. V. ABBREVIATIONS Abbreviation Full name Previous MHLW Ministry of Health, Labor and Welfare MHW PFSB Pharmaceuticals and Food Safety Bureau PAB, PMSB ELD Evaluation and Licensing Division In use in documents issued after January 6, 2001 SD Safety Division (PFSB) CND Compliance and Narcotics Division (PFSB) BBPD Blood and Blood Products Division (PFSB) GAD General Affairs Division (PFSB) FSD Food Sanitation Department (PFSB) MHW Ministry of Health and Welfare PAB Pharmaceutical Affairs Bureau PMSB Pharmaceuticals and Medical Safety Bureau PAB PAD Pharmaceutical Affairs Division, (PAB) In use in documents issued beefore July 1, 1997 ERD-1 First Evaluation and Registration Division, (PAB) ERD-2 Second Evaluation and Registration Division, (PAB) PCD Pharmaceuticals and Cosmetics Division, (PAB) NDD New Drug Division, (PAB) SD Safety Division, (PAB) EAD Economic Affairs Division, (PAB) EGD Inspection and Guidance Division, (PAB) PD Planning Division ODID Office of Induced Damages OBPM Office of Blood Products Management RDD Research and Development Division MDD Medical Devices Division OAUD Office of Appropriate Use of Drugs IGD Inspection and Guidance Division PAFSC Pharmaceutical Affairs and Food Sanitation Council CSIMC Central Social Insurance Medical Council HPB Health Policy Bureau HSB Health Services Bureau HIB Health Insurance Bureau LSB Labor Standards Bureau ESB Employment Security Bureau MAFF Ministry of Agriculture, Forestry and Fisheries METI Ministry of Economy, Trade and Industry MITI FPMAJ Federation of Pharmaceutical Manufacturers' Associations of Japan JPMA Japan Pharmaceutical Manufacturers Association JPWA Japan Pharmaceutical Wholesalers Association JSMI Japan Self-medication Industry PAJ OPMA Osaka Pharmaceutical Manufacturers Association JMA Japan Medical Association JPA Japan Pharmaceutical Association JPO Japan Patent Office Note: 1. Shaded in grey are the abbreviations of defunct (or renamed) entities. Unless abolished, the documents issued by those entities are valid. 2. The abbreviations, which are relatively rarely used, are given in the text of the respective references. 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 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 Known prior May 2003 as Proprietary Association of Japan, PAJ Japanese Medical Devices Regulatory Documents April-June Quarter 2003 Copyright (c) 2001-2003 by JKS LLC - 2 -