The Pharmaceutical Affairs Law, Enforcement Ordinance and Enforcement Regulations 2005/07介绍有以下3个药事法规(three Law, Ordinance and Regulations Revised in July 2005):, ?1 _$ p% z% B/ @ ■ The Pharmaceutical Affairs Law (Law No. 145 Established as of August 10, 1960) Law No. 87 Revised as of July 26, 2005 z( r4 u8 O( I2 i- y2 ~" o/ } ■ The Pharmaceutical Affairs Law, Enforcement Ordinance (Government Ordinance No. 11 Established as of January 26, 1961) Government Ordinance No. 22 Revised as of July 22, 2005 (另文为"No. 252") ■ The Pharmaceutical Affairs Law, Enforcement Regulations (MHLW Ministerial Ordinance No. 1 Established as of February 1, 1961) MHLW Ministerial Ordinance No. 121 Revised as of July 25, 2005 5 \# |; @+ C" c. G 日本薬事法(日文) 官方链接、链接1、链接2(找不到中文或英文版,有的请共享)$ B6 v1 L: z/ h+ Q 日本法令检索(日文) http://wwwhourei.mhlw.go.jp/hourei/html/hourei/contents.html Japanese Law Translation http://www.japaneselawtranslation.go.jp/ JAPAN PMDA GUIDANCE DOCUMENTS http://www.mivado.com/intelligent/news/PMDA.php 法規新訊(台湾/日文) http://www.pitdc.org.tw/link/law.asp, @8 Y% n, k! M) v; q 9 c; F9 _/ C+ \7 V0 P- ^ 薬事法百科事典 http://ja.wikipedia.org/wiki/%E8%96%AC%E4%BA%8B%E6%B3%95 http://www.viswiki.com/ja/%E8%96%AC%E4%BA%8B%E6%B3%95( j3 @, ^. ^, R0 c1 z4 t 2 V6 z" f: m" D. Y2 d- Z 参考资料:; S" n9 w2 f5 Q0 A {/ P 藥事法修訂概要 隨藥事法的修訂所變動之醫藥品GMP及其概要- C B8 T- E& d' x7 E Revised Pharmaceutical Affair Law and Pharmaceutical Development, G. [" ~/ Z* V* }/ X c9 _* k Japan's Pharmaceutical Affairs Law (PAL): Opportunities and Challenges New Japanese Pharmaceutical Affairs Law (JPAL) J% f$ P; p# ?" w, B0 _ - ]+ g* C$ A; i/ O* z9 x! n' | 1 H* O$ j$ ?3 R5 c D. r |
Understanding Japan's Pharmaceutical Affairs Law - Requirements regarding Quality Management Systems * O. O! z6 \- ~; ~9 T: X' a6 ] On July 25, 2002, the Japanese House of Representatives passed and enacted the revised Pharmaceutical Affairs Law (PAL). The original PAL dates back to 1943, with subsequent revisions in 1948, 1960, and 1979. However, the basic purpose of the law has remained the same: to ensure the safety, efficacy, and quality of medical products in Japan.' R6 V) E/ F$ s0 G0 ` The latest revisions to the PAL are meant to address the enhancements in the development and safety of new medical products in the 21st century. According to the Ministry of Health, Labor and Welfare (MHLW), the revised PAL is intended to) V# E7 u& P: w1 q' N% P; ? ' d+ T4 E! a, t1 Q$ G, p • strengthen the safety measures related to medical devices,7 k1 @. z. @. w! j1 X • enhance government regulations with respect to the application of biotechnology and genome technology in developing medical products and • fortify post marketing safety measures and the review system for approval and license while taking international conformity into account. 9 Q1 A" j! g8 I, Y9 o& P The revised PAL is a done deal, and now MHLW has developed or are in the process of developing many of the regulation level details. While the PAL is currently in high-level “Parliamentary Act” form, the ministry has produced regulation-level details through ministerial ordinances and enabling notifications. The ordinances and notifications are always produced in Japanese; however, three key documents are now available, in English, to foreign manufacturers. As a service to our global customers, BSI Japan provides these documents for download.8 y* d3 ~( Y+ M; a8 y" A MHLW Ministerial Ordinance No. 169, 2004 (PDF size 140Kb), Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Medical Devices and In-Vitro Diagnostic Reagents% Y1 E& c% M2 e. H7 H2 q . u B+ m8 q1 W8 L/ q6 |! c This ordinance (No. 169) is the basis for the quality management system for manufacturers of medical devices. The requirements of the quality management system are based on ISO 13485:2003, and this ordinance serves as the basis for GMP/QMS assessments for product certification in Japan. Manufacturers should note that QMS certification, and not ISO 13485:2003 certification, is required for each medical device or family of medical devices. Manufacturers who are currently registered by BSI to ISO 13485:2003 should have no difficulty in obtaining QMS certification under the Japan PAL.' |- K+ W3 c4 n+ H" Z. p) I1 I MHW Ministerial Ordinance No. 2, 1961 (PDF size 119Kb), revised by MHLW Ministerial Ordinance No. 73, 2005, Regulations for Buildings and Facilities of Pharmacies, Etc.0 h1 q1 E0 m1 Z& b This ordinance (No. 2) must be met by foreign medical device manufacturers in order to obtain accreditation by MHLW as a foreign manufacturer. Compliance with the requirements of this ordinance is determined by the Pharmaceutical and Medical Devices Agency (PMDA) and not by any of the 3rd Party Registered Certification Bodies. B0 X3 r ~2 }0 v/ N: ?: `6 y ' _( A- s7 f1 s, D0 O1 r MHLW Ministerial Ordinance No. 136, 2004 (PDF size 63Kb),! n% p* m: y7 R7 Q! I8 v: M Ministerial Ordinance on Standards for Quality Assurance for Drugs, Quasi-drugs, Cosmetics and Medical Devices This ordinance (No. 136) describes the Good Quality Practices (GQP) applicable to all Market Authorization Holders (MAH). Medical device manufacturers are required to formally designated a MAH for their products marketed in Japan and should familiarize themselves with the requirements of this ordinance as part of establishing and maintaining good relationships with their MAH.# q$ ?8 ?, Y& Y0 O, ^: K' R {% t • Navigation of the regulatory process of the Japan PAL • Frequently asked questions about ordinances - x8 Y9 K0 a; |- X4 F$ G For further information on Japan's Pharmaceutical Affairs Law and QMS requirements, please email us at japan.info@bsigroup.com or contact BSI Japan on+81-3-5501-7121.
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Japan Medical Device Regulations: V' G0 e3 z1 ~0 C1 M# u# d, [ We have assembled the following documents as a service to the medical device community. All were published by the Ministry of Health, Labour and Welfare (MHLW) or the Pharmaceutical and Medical Devices Agency (PMDA) and are in PDF format. Many documents are in English and those available only in Japanese are listed as such. If you find a newer version of a document or one that should be included, please email us.! k& Z# U2 @) ]. i V4 a Application for Accreditation of Foreign Manufacturers8 m& @5 J6 F) X! e4 v( P Application for Marketing Approval for Medical Devices, O: a2 Z& l" B; D2 d9 ^ Basic Principles of Biological Safety Evaluation 0 O% T+ Y K9 _$ P: J6 _+ u3 U1 n Guidance on Master File System Handbook for Preparation of Summary Technical Documentation (STED)( p, [- J9 }2 Q % B" R* ~+ W; a$ B$ s7 D Handling Data from Foreign Clinical Studies, c& i" M! V% C1 i7 Y; q! B Handling of Applications for GMP Conformity Audit7 | B3 I' Y! q8 Q+ G# j Q&A for the Handling of Clinical Trial Results on Medical Devices Obtained in Foreign Countries4 K: W. E; _' l1 | . h( @# ?3 g; \& R- x% m Quality Management System Inspections0 J2 U& a6 M+ T. K6 f$ b MHLW Ordinance #2 - Standards for Manufacturing and Quality Control - Tranlsation provided by BSI Japan K.K. MHLW Notification #71 - Revised List of Specially Designated Installation Medical Devices (JAPANESE)+ ~' }5 z- ^ ^: r, N5 D* _ MHLW Notification #78 - Specially Controlled, Controlled, & General Medical Devices (JAPANESE) MHLW Notification #83 - Partial Amendment of Specially Controlled Medical Devices (JAPANESE)0 M+ p. O) V2 a MHLW Notification #85 - List of General (Class I) Devices Requiring Manufacturing and Quality Control (JAPANESE) MHLW Notification #112 - List of Designated Controlled Devices subject to Product Certification (JAPANESE)$ K% K! U! [: N MHLW Ordinance #135 - Standards for Post-market Safety Assurance (JAPANESE)& M9 z C1 X$ P% P7 p7 I) ^' | MHLW Ordinance #136 - Role of MAH - Tranlsation provided by BSI Japan K.K. MHLW Ordinance #169 - Quality Systems Regulations - Translation provided by BSI Japan K.K. MHLW Notification #252 - List of Registered Certification Bodies (JAPANESE); o/ V: O2 n7 r' O8 V MHLW Notification #391 - Appointment of JAAME as Registered Certification Body (JAPANESE) |
来自日本的GMP培训:2007年SFDA杭州冻干药品生产与质量保证技术培训班-日挥株式会社培训资料 目录:, Z9 R8 e/ c. S' \' T1 W$ Q 第1讲 无菌药品检查要点 上海局人证审评中心 张华 第1-24页 r P$ \, u# I, H& E+ r. U9 z 第2讲 日本药事管理概况 沈阳药科大学 工商管理学院,日挥GMP研究室 杨悦 第25-32页 第3讲 日挥课程1 日挥株式会社 产业工程统括总部 渡边惠市郎 第33-41页$ S* h4 ?5 N% p' O 第4讲 日挥课程2 日挥株式会社 产业工程统括总部 渡边惠市郎 第42-52页 第5讲 日挥课程3 日挥株式会社 产业项目括总部 田原繁广 第53-64页2 E7 W9 j0 R3 F 第6讲 日挥课程4 日挥株式会社 产业项目统括总部 渡边惠市郎 第65-74页 第7讲 冻干技术与冻干机 上海东富龙科技有限公司 郑效东 第75-95页$ t' e d3 y% T* p* U x 第8讲 日本药品委托加工的现状 日挥株式会社 产业项目统括总部 陈凯东 第96-98页 参考资料 第99-114页% D7 H+ j0 u! `9 k ?5 g( t: U http://www.westyx.com/bbs/read.php?tid=39079% c/ G( F. O4 n. Z6 ^, }. E1 m http://xdrug.dxy.cn/bbs/topic/9388966 http://www.chinagmp.net/forum.php?mod=viewthread&tid=25940 日本药事法学习总结(医疗器械相关) http://bbs.sdatc.com/read.php?tid=104889 |
日本药事法解读 * T9 n: l+ F2 g( g% K 中国医药保健品进出口商会 2009-08-24 08:37:14 作者:综合部 来源:原创: X- b- A. Y" K! S7 G 1 y4 G h3 m$ l3 q9 I$ e 在与2009年世界制药原料中国展同期举办的“第二届中国与世界医药论坛”上,日本药业协会和日本药监局官员就日本原料药市场和相关法律法规的演讲引起了企业的高度关注。为使广大会员企业更加深入的了解日本医药市场和法规,推动中日原料药贸易稳步发展,我会现将相关资料汇总整理如下:$ v3 j6 s- c8 ^9 z6 q 3 W6 `$ M7 W8 T 1. 中国API如何向往日本市场——日本药业协会角田会长在中国与世界医药论坛上的演讲 2 g! Z4 x" J3 j! ^6 V+ G6 t: C 2. 日本GMP适应性调查(PMDA講演)( Z1 i- ~: g, Z- Q7 H9 Q 4 q, ]3 j U6 `+ h5 N 3. 日本MF制度解读(PMDA講演) & g1 p8 L: H6 u 4. 外国制造商认证制度(PMDA講演)1 T5 b. w' {% f% k1 Y 5. 日本药监局官员与中国企业互动问题汇总 ppt格式见:http://www.r0209.com/bbs/viewthread.php?tid=30610 |
日本国立卫生研究所药品部:http://www.nihs.go.jp/drug/DrugDiv-E.html ● Draft GMP Guidelines For Comments,其中有: ? GMP guidance (Japanese , English under construction)0 m y8 x2 ~$ T0 H ~ ? Technology Transfer guideline (Japanses , English part 1, part 2)* j' Y: d8 I' P8 j& Z. ~' G ? Quality Control Laboratory guideline (Japanese , English-under construction) 有些日本人看起来跟我们一样懒,草案还是2004年的 4 e7 N& W: O4 K, g# K0 d: K9 I ● 日本GMP检查系统研究组年度研究报告,其中有2个英文的可以看看:2 d! f4 e3 V" a$ V0 r ? GMP Guideline for Drug Products ? Global GMP Harmonisation - A Japanese Perspective |
中国医药报在2011年7月8日~29日发表的《日本GMP法规制度简介》连载,作者:梁毅 郦民 1. http://www.yybnet.com/site1/zgyyb/html/2011-07/08/content_51094.htm; P" l; h e! c+ p: x- L+ _, h2 a 2. http://www.yybnet.com/site1/zgyyb/html/2011-07/15/content_51381.htm 3. http://www.yybnet.com/site1/zgyyb/html/2011-07/22/content_51672.htm 4. http://www.yybnet.com/site1/zgyyb/html/2011-07/29/content_52060.htm |
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