日本药事法汇总2014

                    日本药事法汇总2014
' a1 r1 e8 d2 \2 w( R/ a& q  }; R
2 ]7 ?& {+ v( o先汇总下网上在丁香园看到的：
5 ]5 C8 f- D" C/ |- Q5 _However, under the revision to and enforcement of the Pharmaceutical Affairs Law of April 1, 2005, there has been issued a new MHLW Ordinance relating to Standards for Manufacturing Control and Quality Control for Drugs and Medical Devices (MHLW Ordinance No. 179, December 24, 2004), thereby integrating GMP hardware rendered necessary by the characteristics of drugs with GMP software. Specifically, Article 9 establishes basic standards for the buildings and facilities of manufacturing plants where GMP is applicable, and Article 23 establishes standards for the buildings and facilities of manufacturing plants for sterile drugs.
（摘自：Pharmaceutical Administration and Regulations in Japan (INFORMATION IN ENGLISH ON JAPAN REGULATORY AFFAIRS, 2009.3)，做日本注册一定要看。)

日本除了GMP外，还有GQP（Q是Quality Assurance）、QMS等，在MHLW Ministerial Ordinances on GQP and GMP 2005中列出了4个厚生省令（The whole text of these four MHLW Ministerial Ordinances Established/Revised in 2004/2005）:
8 s* E  l$ F; C: C+ H◆　Standards for Quality Assurance of Drugs, Quasi-drugs, Cosmetics and Medical Devices（文字版）
7 [# d( Q" l- x# c$ E4 S/ S2 A7 E3 y% J　　[GQP Ministerial Ordinance]
! T# l) ?2 A3 ^* N　　(MHLW Ministerial Ordinance No. 136 Established as of September 22, 2004)
- {: L$ I) U$ i6 W8 ?5 O◆　Regulations for Buildings and Facilities for Pharmacies etc.（文字版）
2 ~! g5 e4 ?6 |" @　　[Buildings and Facilities Regulations]
　　(MHLW Ministerial Ordinance No. 180 Revised as of December 24, 2005)
◆　Standards for Manufacturing Control and Quality Control of Drugs and Quasi-drugs（文字版用Nuance OmniPage 17识别）
3 t' R: v2 Y* G- {6 f" h　　[GMP Ministerial Ordinance on Drugs and Quasi-drugs]
" h7 I1 a- ~$ ?& E　　(MHLW Ministerial Ordinance No. 179 Revised as of December 24, 2004)
4 o6 @$ W: S% w◆　Standards for Manufacturing Control and Quality Control of Medical Devices and In Vitro Diagnostics（文字版）
8 w- ~' W3 E2 o. \　　[QMS Ministerial Ordinance on Medical Devices and In Vitro Diagnostics]
　　(MHLW Ministerial Ordinance No. 169 Revised as of December 17, 2004)

* ^  X; C6 L6 @! r; a% }4 p在The Japanese GMP Regulations 2003中还列出以下相关厚生省令和通知（The Ministry of Health, Labour and Welfare (MHLW) Ministerial Ordinances and MHLW Director-General Notification related to the Japanese GMP for Drugs are）：
■　Regulations for Buildings and Facilities for Pharmacies, etc. (MHW Ministerial ordinance No. 2 dated Februaryl , 1961; Amended: MHLW Ministerial Ordinance No. 92 dated May 20 , 2003)
■　Regulations for Manufacturing Control and Quality Control of Drugs (MHW Ministerial ordinance No. 16 dated March 12 , 1999; Amended: MHLW Ministerial Ordinance No. 95 dated May 20, 2003)
# ?! I, ^( H' E9 G+ i, M■　Regulations for Importing/Retail Management and Quality Control of Drugs and Quasi-drugs (MHW Ministerial Ordinance No. 62 dated June 2, 1999; Amended: MHLW Ministerial ordinance No. 97 dated May 20, 2003)
■　MHLW Ministerial Ordinance on the Manufacturing Control and Quality Control When Manufacturing of a Single Product of the Drugs, Quasi-drugs, Cosmetics and Medical Devices Specified under Article 1-2-2, Paragraph 1, Items 1, 2 and 4 of the Enforcement ordinance of the Pharmaceutical Affairs Law is Performed at Two or More Manufacturing Sites (MHW Ministerial Ordinance NO. 26 dated March 30, 1994; Amended: MHLW Ministerial Ordinance No. 93 dated May 20, 2003)
■　Good Manufacturing Practice Guide for Active Pharmaceutical ingredients (PFSB Director-General Notification No. 1200 dated November 2, 2001)
, L0 ?( z: v/ Z2 ~/ C2 `
2 W3 e- U  w1 {8 Q4 P另外还有：
Radiopharmaceuticals Manufacturing and Handling Regulations
1 h& X5 w4 S( L: p% e: B* u" e: ~6 X(MHW Ordinance No. 4, 1961)
& b4 I! |. v3 c& I
官方网站：
! u& C6 Q- f) z1 bhttp://www.pmda.go.jp/english/service/ministerial.html
http://www.pmda.go.jp/english/service/gmp.html
; {1 S& r% ~! u5 |( u& r; Fhttp://www.pmda.go.jp/english/service/qms.html
认定外国制造业者列表：http://www.pmda.go.jp/operations/shonin/info/foreign/gaikokuseizounintei.html


# q" S% |7 K2 S% @0 K. q
/ q! n; o7 u# z# c0 e$ ?" K9 g

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）： % b# W  T) K  L0 c2 H. o. d■　The Pharmaceutical Affairs Law & C) t# x1 ~& Z7 H　　(Law No. 145 Established as of August 10, 1960) 　　Law No. 87 Revised as of July 26, 2005 ■　The Pharmaceutical Affairs Law, Enforcement Ordinance 8 K' l6 ?" E# K　　(Government Ordinance No. 11 Established as of January 26, 1961) ! D# S: v$ [- u/ h8 V& g　　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 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） 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/ % O& p5 g! t3 \" H% s4 yJAPAN 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 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 参考资料： : }9 j1 }- d. }9 s4 r" R; G6 H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 4 S; z5 O2 C" H+ N" ?( w& sRevised Pharmaceutical Affair Law and Pharmaceutical Development % ?8 H6 |4 V9 Y0 s$ [2 h: J" eJapan's Pharmaceutical Affairs Law (PAL): Opportunities and Challenges $ p- ~$ P7 d- x2 {New Japanese Pharmaceutical Affairs Law (JPAL) * W+ I  Y& p! l/ r( E" s) ?

9 E! [% j! [- C0 G$ e$ {

Understanding Japan's Pharmaceutical Affairs Law - Requirements regarding Quality Management Systems 0 v7 Z% F, T; H: H6 d + Z4 b1 M  A% f) l+ rOn 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. + }' G& ]1 ~( _' A: |* rThe 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 " d$ D# {1 k( y6 J6 ]: [• strengthen the safety measures related to medical devices, • enhance government regulations with respect to the application of biotechnology and genome technology in developing medical products and % t  X: b' k* R& O; V• fortify post marketing safety measures and the review system for approval and license while taking international conformity into account. & P% V) j/ g9 w( u2 B1 }6 ^ ) t& W% ~+ w- [2 j0 h  F- yThe 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. 2 u1 |: I2 o! Z6 t 1 @$ ^0 v- S2 h8 K, K( G, xMHLW Ministerial Ordinance No. 169, 2004　（PDF size 140Kb), + R" i# z% K# `: Y$ u& c, eMinisterial Ordinance on Standards for Manufacturing Control and Quality Control for Medical Devices and In-Vitro Diagnostic Reagents 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. , o) B) M9 Q( O5 v# D( ?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. ( Q& x% E2 _0 X* d6 [8 nThis 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. + w; P8 P- w: ]' R MHLW Ministerial Ordinance No. 136, 2004 （PDF size 63Kb), Ministerial Ordinance on Standards for Quality Assurance for Drugs, Quasi-drugs, Cosmetics and Medical Devices / w- Q3 D2 Z1 e$ ?3 R% [ ! K4 D8 V: Q" Q$ d5 {4 P" f) j$ MThis 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. / o* [& w6 a1 f( _! s) M • Navigation of the regulatory process of the Japan PAL • Frequently asked questions about ordinances / I4 ]- \8 u$ ^/ TFor 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. Frequently Asked Questions regarding Japan's Pharmaceutical Affairs Law and QMS Requirements 2 r" v" p$ Z2 y; n, O( z0 A* p9 p ) {1 j# v) j& v7 }BSI has identified the top 22 ordinances, notifications and memorandums which are fundamental to navigating the regulatory process of the Japan PAL. Ministerial Ordinances 2 T& J" e, L  `7 e7 J* KQuestion: 1 d9 K' ], t2 G& hIn various presentations about the new Japan PAL, there is a reference made to “GMP” requirements, but we have also seen references to “QMS” requirements. Are “GMP” and “QMS” used interchangeable?   j% {3 L' E* y* n. J5 j1 L6 _In Japan, “GMP” means Good Manufacturing Practices and applies to manufacturers of drugs and quasi-drugs. “QMS” means Quality Management System and applies to manufacturers of medical devices and IVD reagents. To differentiate between drug and device manufacturers, “GMP” and “QMS” should not be used interchangeably. Question: Ministerial Ordinance No. 169 appears to describe the general QMS requirements for a medical device manufacturer. Does this document apply to all locations for all device classifications? 3 F# V; q& c# {7 S6 l. { ' P/ d/ M* w0 D, O3 u3 LGMP (MHLW Ministerial Ordinance No.169, 2004) is required for all manufacturing locations for class IV, III, and II medical devices, and those Class I medical devices specifically designated by MHLW. BSI Japan, as part of the product certification process, will conduct assessments for Designated Control Medical Device (i.e., eligible Class II devices), as designated by MHLW in accordance with this ordinance. 3 W1 V$ Y* {% j: N0 hChapter 2 of this ordinance stipulates the requirements for general medical devices, whereas chapter 3 stipulates requirements for the manufacturer of Japanese importers of medical devices conducting labeling, testing, storage, etc. Chapter 4 stipulates the requirements for Biological-origin Medical Devices and chapter 5 stipulates the requirements for In-Vitro Diagnostic Reagents. 8 X9 }% ^; Q4 | Question: ) v  G% f0 `/ `# t) t9 d8 I# \We are a manufacturer of IVD Reagents and Ministerial Ordinance No. 169, Article 80, is confusing with respect to the QMS requirements. What exactly is required? 5 b( [% Q9 Q; Q6 Z+ A Article 80 describes the QMS requirements for manufacturers of IVD Reagents and contains a statement that the provisions of “Chapter 2 and Chapter 3 shall be applied mutatis mutandis”, meaning that all requirements of the articles in these two chapters (i.e., Article 3 through Article 72) are applicable to manufacturers of IVD Reagents, with specific modifications as indicated in Article 80. , o% Q' @, m4 s- s+ q3 K7 x Question: Ministerial Ordinance No. 2 contains additional building and environmental requirements for drug, cosmetic and device manufacturers (includes extra requirements for sterile and biological devices). Do these requirements, along with Infrastructure Requirements from Ordinance 169, apply to all medical device manufacturers? The short answer is YES. Specifically, requirements exist for building and environmental controls in both ordinances which the manufacturer of medical devices must meet. In Ordinance No. 2, the requirements for medical devices are indicated in Section 4, Articles 14 to Article 14-4. These requirements apply to all medical device manufacturers and must be meet in order to obtain either the domestic Japanese Manufacturer’s license or MHLW accreditation as a Foreign Manufacturer. While assessment to the requirements of Ordinance 169 may be done by BSI as part of the product certification process, assessment of compliance to Ordinance No. 2 shall be conducted by PMDA and not by any of the Registered Certification Bodies. Question: * [  ]5 V# u' d" N# BMinisterial Ordinance No. 136 appears to be the requirements to MAH (the importer/distributor in Japan). Do these requirements apply only in Japan? % ]7 c4 c$ e' uThe Good Quality Practices (GQP) specified in MHLW Ministerial Ordinance No.136, 2004 are requirements for the MAH located in Japan, i.e. the distributors and the importers in Japan, and not requirements for either the Japan or overseas manufacturers. The assessment of compliance to the GQP, for each MAH, is conducted by the prefectural government where the MAH has their registered place of business. Every manufacturer should familiarize themselves with the requirements of this ordinance, because of the specific requirements stipulating the cooperation between the MAH and the medical device manufacturer. / J7 w3 s( n3 B5 @7 Q Question: The requirements of Ministerial Ordinance No. 136 seem very limited for the MAH and only pertain to records. Is this true? 0 p. N. j- u  n2 `" e! h , C* S" z! q& A% e+ K' eThe requirements for each MAH responsible for medical devices are stipulated in Article 1, Article 2 and from Article 21 to Article 25. In Article 25, there is a description of “Provisions to be applied Mutatis Mutandis”, i.e. Article 25 quotes from Articles 3 - 16. Therefore, the requirements of Article 3 to Article 16 are applicable, although some excluding items are indicated specifically. Therefore, the GQP requirements are not only concerned with the records which must be kept by the MAH. The GQP requirements include all other requirements indicated in the above articles. ) q% D1 {9 j9 K$ J! l( TQuestion: ) C' Y- ?. s% i2 }- N0 fWould BSI conduct assessments against all of these documents where the products are within the scope of the third party program? BSI Japan will conduct QMS assessments according to Ordinance No. 169, and only for those eligible Class II devices. Currently, there are a total of 1,785 different devices which MHLW has classified as Class II device, and within our accreditation as a Registered Certification Body, BSI Japan provides product certification for 776 which are Designated Control Medical devices. As other devices become eligible, BSI will be able to conduct the QMS assessments for those products. A QMS assessment, according to Ordinance No. 169, for all Class IV and Class III devices, and those designated Class I devices, will be conducted by PMDA. Other Class I devices are exempt from QMS certification. 0 @; {: V7 Q3 a0 FAssessments of manufacturers, according to Ordinance No. 2, are conducted by PMDA and assessments of MAH, according to Ordinance No. 136, are conducted by the Japan Prefectural Government. # Q- Z; T) n  P" p+ x' i 1 u) i+ [. M) A4 v! S. m; a; C- M" g 7 N: D# U; {; w+ {3 e0 _& {( ~# l, F

( w6 F1 r% X* w5 w# r# n


) w3 q3 m, L6 x1 Q! D% x6 h

Japan Medical Device Regulations - K' [8 T3 M. B' |1 w- B3 k2 t+ h 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. ' y& }. B8 l6 X* i3 c3 I" ] # ?& ~) Y& f. O7 l  _8 b: aApplication for Accreditation of Foreign Manufacturers - H1 u5 J8 V' IApplication for Marketing Approval for Medical Devices $ ^8 A" V" i9 T' d1 l, V+ yBasic Principles of Biological Safety Evaluation ; z( n" \1 e% x7 S0 n1 z5 e Guidance on Master File System ! ~. O3 d- V/ J! D. V/ jHandbook for Preparation of Summary Technical Documentation (STED) Handling Data from Foreign Clinical Studies Handling of Applications for GMP Conformity Audit Q&A for the Handling of Clinical Trial Results on Medical Devices Obtained in Foreign Countries Quality Management System Inspections * N. v7 R: V/ Y' k9 X+ RMHLW 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) 9 I9 Z1 o& g: C. ~( LMHLW Notification #78 - Specially Controlled, Controlled, & General Medical Devices (JAPANESE) MHLW Notification #83 - Partial Amendment of Specially Controlled Medical Devices (JAPANESE) 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) ' H5 q2 R8 ?+ l' bMHLW Ordinance #135 - Standards for Post-market Safety Assurance (JAPANESE) ' [: ~0 z9 _4 D8 Z7 _MHLW Ordinance #136 - Role of MAH - Tranlsation provided by BSI Japan K.K. $ X% a& g$ I9 z9 G6 Y& BMHLW Ordinance #169 - Quality Systems Regulations - Translation provided by BSI Japan K.K. 9 ^) x& B$ Z& Z6 t$ A  WMHLW Notification #252 - List of Registered Certification Bodies (JAPANESE) % C0 a8 s% L0 B: h, QMHLW Notification #391 - Appointment of JAAME as Registered Certification Body (JAPANESE)

3 F8 ~! A: j2 Q. D5 C. C

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 ! |: c$ s( u7 [4 E目录: 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 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 & @! Y1 ^* h9 z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 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 ; C6 e; `- k1 s, ]9 L: P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 % m: t$ z* g$ Y# u+ Y" x' I+ Z( I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 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 - i6 G# M1 v0 s% G参考资料 第99-114页 http://www.westyx.com/bbs/read.php?tid=39079 http://xdrug.dxy.cn/bbs/topic/9388966 % @7 @7 e- e9 t, U+ Ohttp://www.chinagmp.net/forum.php?mod=viewthread&tid=25940 - d6 Z4 j# b9 i, f, v5 B& b 0 A- C0 u3 C# L  P日本药事法学习总结(医疗器械相关) http://bbs.sdatc.com/read.php?tid=104889

/ j. f" ?$ w9 s! J/ v( V) i1 J

5 l# t- P% h8 m+ C" Z+ n) c

日本药事法解读 - i- h5 j; U  F1 a% Z  D 中国医药保健品进出口商会 ' Q& E! J0 A" S9 D+ f. L9 b0 k$ S* F) ]2009-08-24 08:37:14 作者:综合部 来源:原创 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： ) z. _7 L4 x' X) z/ ]" Q 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 # R/ }  x2 |  W/ a# y2. 日本GMP适应性调查(PMDA講演) 3. 日本MF制度解读(PMDA講演) - a5 k7 ]' S: o" @3 p" P 4. 外国制造商认证制度(PMDA講演) 0 N& d# x( z) S8 _" ?6 b5. 日本药监局官员与中国企业互动问题汇总 % U9 d& k+ N4 y+ C8 l ppt格式见：http://www.r0209.com/bbs/viewthread.php?tid=30610

+ Z. \! n' }" z, J- O( o5 i
+ `) }; p1 O  I& D, |1 R

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) 5 i$ M& x, w& f# |0 m4 Y　? Technology Transfer guideline (Japanses , English part 1, part 2) 8 j8 X, h8 L9 J7 g5 {- T" F0 _/ l　? 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 - o0 [, |- K& }                                登录/注册后可看大图 5 U( R: z, R, K% R% z3 v●　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： 5 O) F: \: r$ H$ g0 N2 L8 J5 O　? GMP Guideline for Drug Products + e% P5 Q& d% K0 `; ]* N' t　? Global GMP Harmonisation - A Japanese Perspective

$ P: t8 Y3 W+ `: V8 L- ]# p& `8 y

/ U2 N' L, Y: \# r' \
原料药日本注册
6 f4 C4 N5 K# ^  T
, c( U) [9 Z; u  n- i) G) X/ n6 |关注日本药事法（PAL）

2002年7月31日，日本药事法的改正稿公布，2005年4月1日正式实施。该次药事法的修订必将对21世纪的日本医药工业带来重大变革，特别是在技术进步和经济活动多样化方面。此次药事法的改正，引入J-DMF体系，并在许可证审批发放，上市后安全监管等多个方面进行了重大调整，必将对日本药品市场产生深远影响。
! L' `; r$ w3 Z& o: C8 t) W
MDC集中专家对此次日本药事法改正进行深入研究，分析比较新法与旧法在各个部分的差别以及对日本药品市场的影响，近期推出多个主题介绍日本原料药的注册流程及市场分析。

新旧日本药事法比较-生产/上市许可体系（Manufacturing/Marketing Approval System）

( r) b6 V/ b8 ^6 W- E在旧的药事法下，生产一个品种的药品需要两个营业执照和一个生产许可。此次修订将旧法下的生产营业执照（manufacturing business license）分成生产/上市营业执照（"manufacturing/marketing business license"）和生产营业执照（"manufacturing business license"）。
! A$ i. j2 w( u! }拥有新法下生产/上市营业执照的公司可以生产被许可的药品，同时对该药品的有效性、安全性和质量承担全部责任。该公司可以引进拥有新法下生产营业执照的公司生产的药品，生产药品的公司应符合GMP。另外，新的药事法将药品生产许可（drug manufacturing approval）和产品生产证书（product manufacturing license）合并成一个药品生产/上市许可（"drug manufacturing/marketing approval"）。旧法下的产品生产证书被废止。
: @, u8 q2 J. m0 t
: u/ ^# F2 X! y5 l0 c3 a8 z新旧药事法比较-生产/上市营业执照（The Manufacturing/Marketing Business License）
2 K0 N4 c) E; P0 T, O7 \5 K
新法生效后，对每类产品分别颁发营业执照，所以营业执照反映每个公司的经营范围。如果一个公司希望同时生产和经营处方药品（第一类）和OTC药品（第二类），则该公司必须拥有2个营业执照。如果该公司要经营化妆品类产品，则它需要有化妆品类产品的营业执照。为满足获得这些执照的要求，公司必需有质量控制和上市后安全管理系统，同时对每个种类的药品，公司必需配备一名生产和经营经理负责该类产品。管理体系可以根据每个营业执照覆盖的产品特点有所区别。营业执照每5年更新一次。
5 g/ \3 |7 x+ I, x
; Z! u3 K* G2 H4 F" C2 E新旧药事法比较-质量控制系统（The Quality Control System）
# B+ z7 `0 n4 o+ ?
新法下，一个拥有完善质量控制系统的药品经营企业不再必须拥有自己的生产工厂。以前，在旧法下，生产工厂对于获得药品生产许可证是必需的。此次药事法的修改使得通过委托外部生产厂家承担药品生产成为可能。但是，拥有生产/上市执照的企业仍然对经营的药品负责，该企业必须建立完善的体系来管理和监控合同生产工厂的GMP管理。目前，药管当局正在考虑建立该体系的必须标准。从外部引入药品生产也意味着制药公司的生产部门可以组成独立的公司。这样可以引导药品生产在不同公司间进行，提高合同生产企业的使用。这样也可以使风险投资类企业更容易进入市场，因为他们不再必须拥有自己的生产工厂。

新旧药事法比较-药品生产（Manufacturing）

药品生产性企业必需拥有药品生产营业执照。对每类药品都要有该类药品的生产营业执照，如非无菌类和无菌类产品。工厂的管理结构和硬件设施满足GMP 的要求是获得生产营业执照的前提。对于将产品出口到日本的国外药品生产者必须获得日本厚生省颁发的GMP证书。厚生省在颁发证书前要按照适用于日本药厂的标准对国外的药品生产者进行现场检查。目前正在推动与EUGMP证书的互认。互认程序的进展对于保证修改后药事法下许可体系的平稳运行非常必要。既然GMP是许可体系的基础，在GMP方面的国际协调是非常重要的。
+ v3 W6 q* w. n) |0 j4 r4 A& j! O
" o% V1 G- r& x7 x4 w$ f新旧药事法比较-Drug Master File

生产和上市许可体系修改后，原料药可以被制剂许可证覆盖而不必分开许可。这种修改伴随着引用DMF体系，DMF体系已经为欧洲和美国使用，用以保护原料药生产者的知识产权如生产工艺等。日本已经建立了类似欧美的DMF体系。
% q+ ^5 w& }' B( I0 \; B
% n; w# }, U! `' T# ]  u
中国医药报在2006-04-01~2006-08-08发表的日本药事管理法规连载，作者：梁毅
4 Q' W; }, k# z+ K: l+ A
( q$ l; `. t5 P1 z0 r01 日本药学会的成立
02 药事法规发展简介
03 《药事法》的修订
: T9 C# O% e% M* h04 不良反应监测报告制度
05 20世纪80年代药品法规的发展
06 药物临床试验管理规范的颁布
9 c5 b: q$ _& w5 B& z7 H: ^07 20世纪90年代药品法的发展（上）
08 20世纪90年代药品法的发展（中）
09 20世纪90年代药品法的发展（下）
10 新《药事法》的实施
0 W" U" T+ A5 Q$ {! B0 G$ q. g11 新药开发的程序
12 有关新药开发的管理规范

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 , f' B: S4 \. L) H1 t1. http://www.yybnet.com/site1/zgyyb/html/2011-07/08/content_51094.htm 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

4 V' \0 O2 Q. z; ?  m  T目录：
1、日本药事法J-PAL[1]_training_materials；
2、日本药事法讲义；
5 ]6 e0 Z2 d8 E1 m3、日本药事法解读。
. U6 ^) E/ Y3 n$ K9 x

游客，如果您要查看本帖隐藏内容请回复

! _( x: N/ {: \! l
$ K' B9 K- e; a1 F日本gmp.rar(35.41K)JGMP.rar(500.52K)

谢谢分析，分享

好资源，谢谢楼主分享

谢谢分享！

谢谢分享，学习一下

谢谢楼主分享

谢谢分享~非常感谢学习一下

学习，收藏，谢谢分享

感谢分享。

没有全文的吗？