{"id":10297,"date":"2020-11-03T15:21:20","date_gmt":"2020-11-03T06:21:20","guid":{"rendered":"http:\/\/prm-sv2.japta.or.jp\/?page_id=10297"},"modified":"2020-11-27T00:55:01","modified_gmt":"2020-11-26T15:55:01","slug":"laws","status":"publish","type":"page","link":"https:\/\/www.japta.or.jp\/en\/laws\/","title":{"rendered":"Laws"},"content":{"rendered":"

Laws, Ordinances and Administrative Notices relating to API manufacturers overseas<\/h3>\n

\n\u3000\u5f53\u5354\u4f1a\u306b\u304a\u3044\u3066\u3001\u539f\u85ac\u7b49\u306e\u5916\u56fd\u88fd\u9020\u696d\u8005\u304c\u65e5\u672c\u306e\u85ac\u4e8b\u5236\u5ea6\u3092\u7406\u89e3\u3059\u308b\u305f\u3081\u306b\u5fc5\u8981\u3068\u306a\u308b\u95a2\u4fc2\u6cd5\u4ee4\u53ca\u3073\u901a\u77e5\u7b49\u306e\u82f1\u8a33\u30ea\u30b9\u30c8\uff08\u65e5\u672c\u8a9e\u30fb\u82f1\u8a9e\u4f75\u8a18\uff09\u3092\u4f5c\u6210\u3044\u305f\u3057\u307e\u3057\u305f\u3002
\n\u3053\u306e\u30ea\u30b9\u30c8\u306b\u3088\u308a\u3001\u65e5\u672c\u306b\u304a\u3044\u3066\u82f1\u8a33\u304c\u884c\u308f\u308c\u3066\u3044\u308b\u85ac\u4e8b\u6cd5\u3001\u540c\u653f\u7701\u4ee4\u3001\u539f\u85ac\u95a2\u4fc2\u901a\u77e5\u53ca\u3073\u89e3\u8aac\u6587\u7b49\u306e\u82f1\u8a33\u5143\u3092\u3054\u7d39\u4ecb\u3059\u308b\u3068\u5171\u306b\u3001\u305d\u308c\u3089\u304c\u516c\u8868\u3055\u308c\u3066\u3044\u308b\u30db\u30fc\u30e0\u30da\u30fc\u30b8\u53c8\u306f\u5f53\u5354\u4f1a\u3067\u72ec\u81ea\u306b\u82f1\u8a33\u3057\u305f\u901a\u77e5\u7b49\u3092\u4e00\u62ec\u95b2\u89a7\u3067\u304d\u308b\u3088\u3046\u3054\u6848\u5185\u3057\u3066\u304a\u308a\u307e\u3059\u3002(\u4e00\u90e8\u4e2d\u56fd\u8a9e)
\n\u539f\u85ac\u95a2\u4fc2\u901a\u77e5\u53ca\u3073\u89e3\u8aac\u306e\u3046\u3061\u5f53\u5354\u4f1a\u3067\u82f1\u8a33\u3057\u305f\u3082\u306e\u306f\u73fe\u5728\u4f1a\u54e1\u4ee5\u5916\u306e\u65b9\u306b\u306f\u975e\u516c\u958b\u3068\u3057\u3066\u3001\u4f1a\u54e1\u5c02\u7528\u30da\u30fc\u30b8\u306b\u63b2\u8f09\u3057\u3066\u304a\u308a\u307e\u3059\u304c\u3001\u5f53\u5354\u4f1a\u4e8b\u52d9\u5c40\u306b\u304a\u554f\u3044\u5408\u308f\u305b\u3044\u305f\u3060\u3051\u308c\u3070\u3001CD\u7248\u3092\u9812\u5e03\u3057\u3066\u304a\u308a\u307e\u3059\u306e\u3067\u3001\u305c\u3072\u3054\u6d3b\u7528\u304f\u3060\u3055\u3044\u3002<\/p>\n

Our association provides a list of regulations and laws for better understandings of the system with foreign API manufacturers. The list indicates English translations available in Japan as well as organizations which conducted the translation. The CD-ROM with the these information is available for sale from our association.<\/p>\n


\n\u25cf\u9812\u5e03\u3055\u305b\u3066\u3044\u305f\u3060\u3044\u3066\u3044\u308b\uff23\uff24\u306f\u30012014\u5e74\u5ea6\u7248\u3067\u3059\u3002
\n Currently distributed CD-ROM is for 2014.<\/font> <\/p>\n

\n\n\n\n\t\n\t\n\t
\uff23\uff24\uff0d\uff32\uff2f\uff2d\u3000\uff1a<\/td>\u4e00\u822c\u30005,000\u5186\uff08\u7a0e\u8fbc\uff09\uff0f\u3000\u4f1a\u54e1\u30003,000\u5186\uff08\u7a0e\u8fbc\uff09
\n\uff08\u203b\u9001\u6599\u5225\u9014\uff1a\u3000\u4e00\u5f8b200\u5186\uff08\u56fd\u5185\uff09\uff09\u3000
\nUnit Price \u3000JPY5,000._ \u3000\u3000+\u3000\u3000Shipping charge \u3000JPY800._(overseas)<\/td>\n<\/tr>\n
\u554f \u5408 \u305b \u5148\u3000\uff1a
\nInquiry<\/td>		\u4e00\u822c\u793e\u56e3\u6cd5\u4eba\u65e5\u672c\u85ac\u696d\u8cbf\u6613\u5354\u4f1a\u4e8b\u52d9\u5c40
\nSecretariat JAPTA
\nTEL : 03-5918-9101\u3000\uff0f\u3000+81-3-5918-9101
\nFAX : 03-5918-9103\u3000\uff0f\u3000+81-3-5918-9103
\nE-mail: nichiyakubo@japta.or.jp<\/a><\/td>\n<\/tr>\n
\u6ce8\u6587\u66f8\u3000\uff1a
\nOrder Sheet<\/td>		\u65e5\u672c\u8a9e (Japanese)<\/a>\u3000\uff0f\u3000\u82f1\u8a9e\uff08English\uff09<\/a><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
\n\u203b\u3054\u6ce8\u6587\u306e\u969b\u306f\u3001\u6ce8\u6587\u66f8\u306b\u5fc5\u8981\u4e8b\u9805\u3092\u8a18\u5165\u306e\u4e0a\u3001\u4e8b\u52d9\u5c40\u307e\u3067FAX\uff0803-5918-9103\uff09\u3000
\n\u3000\u307e\u305f\u306f\u30e1\u30fc\u30eb\uff08nichiyakubo@japta.or.jp<\/a>\uff09\u306b\u3066\u3054\u6ce8\u6587\u304f\u3060\u3055\u3044\u3002\u3000<\/p>\n

\u3000<\/p>\n

Please fill out an order sheet and send it on E-mail(nichiyakubo@japta.or.jp<\/a>)
\nor FAX(+81-3-5918-9103).<\/p>\n

\u3000<\/p>\n

\u3054\u4e0d\u660e\u306a\u70b9\u7b49\u3054\u3056\u3044\u307e\u3057\u305f\u3089\u3001\u4e8b\u52d9\u5c40\u307e\u3067\u3054\u9023\u7d61\u304f\u3060\u3055\u3044\u3002
\nIf you have any question, please contact our secretariat.<\/p>\n

\u203b\u4f1a\u54e1\u306e\u7686\u69d8\u306b\u3064\u304d\u307e\u3057\u3066\u306f\u3001\u5c02\u7528\u306e\u901a\u77e5\u82f1\u8a33\u30da\u30fc\u30b8\u3044\u304a\u3044\u3066\u3001\u82f1\u8a33\u6587\u304c\u95b2\u89a7\u53ef\u80fd\u3067\u3059\u3002\u30b3\u30c1\u30e9<\/a> \u3092\u3054\u53c2\u7167\u304f\u3060\u3055\u3044
\n\u203bMembers are able to view the English translated notifications on our exclusive website. Please click HERE.<\/a> <\/p>\n

\u3000<\/p>\n

\u2193\u30dc\u30bf\u30f3\u3092\u30af\u30ea\u30c3\u30af\u3059\u308b\u3068\u3001\u8a72\u5f53\u7b87\u6240\u3078\u30b8\u30e3\u30f3\u30d7\u3057\u307e\u3059\u3002
\n\n\n\n\n\t\n\t\n\t
LAW<\/span><\/a><\/td>ACCREDITATION<\/span><\/a><\/td>APPROVAL<\/span><\/a><\/td>\n<\/tr>\n
GMP<\/span><\/a><\/td>GMP Compliance
\nInspection<\/span><\/a><\/td>		GQP<\/span><\/a><\/td>\n<\/tr>\n
MF<\/span><\/a><\/td>PHARMACOPOEIA<\/span><\/a><\/td><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/p>\n

\u3000<\/p>\n

<\/a><\/p>\n

\u3010\u6cd5\u95a2\u4fc2\uff0fLAW\u3011<\/h3>\n\n\n\n\n\t\n\n\t\n\t\n\t\n\t\n\t\n\t\n\t
\u65e5\u4ed8\/
\n\u767a\u51fa\u756a\u53f7<\/th>		\u901a\u77e5\u7b49\u4ef6\u540d<\/th>\u901a\u77e5\u5185\u5bb9<\/th>\u901a\u77e5URL<\/th>\n<\/tr>\n<\/thead>\n
Dated\/
\nNotification No.<\/td>		Title<\/td>Contents<\/td>URL of notification<\/td>\n<\/tr>\n
\u5e73\u621016.07.09
\n
\n\u85ac\u98df\u767a\u7b2c0709004\u53f7<\/td>		\u85ac\u4e8b\u6cd5\u53ca\u3073\u63a1\u8840\u53ca\u3073\u4f9b\u8840\u3042\u3063\u305b\u3093\u696d\u53d6\u7de0\u6cd5\u306e\u4e00\u90e8\u3092\u6539\u6b63\u3059\u308b\u6cd5\u5f8b\u7b49\u306e\u65bd\u884c\u306b\u3064\u3044\u3066 <\/td>\u6cd5\u904b\u7528\u306e\u305f\u3081\u306e\u57fa\u672c\u7684\u306a\u8aac\u660e<\/td>CD\u306b\u53ce\u8f09<\/td>\n<\/tr>\n
July 9,2004
\n
\nNotification No.0709004 of the PFSB<\/td>		Enforcement of Law Partially Revising the Pharmaceutical Affairs Law and the Blood Collection and Donation Service Control Law<\/td>Basic explanations for legal operation<\/td>Listed in the CD<\/td>\n<\/tr>\n
H17.7.26
\n\u6cd5\u7b2c87\u53f7
\n
\n
\n
\nH17.7.22
\n\u653f\u4ee4\u7b2c252\u53f7
\n
\nH17.7.25
\n\u539a\u751f\u52b4\u50cd\u7701\u4ee4\u7b2c121\u53f7<\/sapn> <\/td>		\u85ac\u4e8b\u6cd5
\n\uff08\u85ac\u4e8b\u6cd5\u53ca\u3073\u63a1\u8840\u53ca\u3073\u4f9b\u8840\u3042\u3063\u305b\u3093\u696d\u53d6\u7de0\u6cd5\u306e\u4e00\u90e8\u3092\u6539\u6b63\u3059\u308b\u6cd5\u5f8b\uff09
\n
\n\u540c\u653f\u4ee4
\n
\n\u540c\u539a\u751f\u52b4\u50cd\u7701\u4ee4<\/td>		\u6539\u6b63\u85ac\u4e8b\u6cd5\u3001\u540c\u653f\u4ee4\u3001\u540c\u539a\u751f\u52b4\u50cd\u7701\u4ee4
\n
\n\uff08\u85ac\u4e8b\u6cd5\u306e\u516c\u5f0f\u82f1\u8a33\u306f\u3042\u308a\u307e\u305b\u3093\u3002\uff09<\/td>
-<\/div><\/td>\n<\/tr>\n
July 26,2005
\nLaw No.87
\n
\nJuly 22,2005
\nGovernment Ordeinace No.252
\n
\nJuly 25,2005
\nMinisterial Ordinance No.121 <\/td>		The Pharmaceutical Affairs Law
\n
\nThe Pharmaceutical Affairs Law, Enforcement Ordinance
\n
\nThe Pharmaceutical Affairs Law, Enforcement Regulations<\/td>		No official translation in English on Pharmaceutical affairs law (PAL).<\/td>
-<\/div><\/td>\n<\/tr>\n
2013\u5e74\u5ea6\u7248<\/td>\u65e5\u672c\u306e\u85ac\u4e8b\u884c\u653f<\/td>\u85ac\u4e8b\u884c\u653f\u306e\u6982\u8981\u3002<\/td>CD\u306b\u53ce\u8f09<\/td>\n<\/tr>\n
March,2013<\/td>Pharmaceutical Administration and Regulations in Japan<\/td>Information on Japanese Regulatory Affairs<\/td>Listed in the CD<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n\n

<\/a><\/p>\n

\u3010\u8a8d\u5b9a\u95a2\u4fc2\uff0fACCREDITATION\u3011<\/h3>\n\n\n\n\n\t\n\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t
\u65e5\u4ed8\/
\n\u767a\u51fa\u756a\u53f7<\/th>		\u901a\u77e5\u7b49\u4ef6\u540d<\/th>\u901a\u77e5\u5185\u5bb9<\/th>\u901a\u77e5URL<\/th>\n<\/tr>\n<\/thead>\n
Dated\/
\nNotification No.<\/sapn><\/td>		Title<\/td>Contents<\/td>URL of notification<\/td>\n<\/tr>\n
-<\/div><\/td>
\u5916\u56fd\u88fd\u9020\u696d\u306e\u8a8d\u5b9a\u7533\u8acb\u306b\u3064\u3044\u3066\uff08\u6982\u8981\uff09<\/td>\u5916\u56fd\u88fd\u9020\u696d\u306e\u8a8d\u5b9a\u7533\u8acb\u306e\u624b\u7d9a\u304d\u3068\u5be9\u67fb\u306b\u5fc5\u8981\u306a\u6dfb\u4ed8\u8cc7\u6599\u306b\u3064\u3044\u3066\u306e\u8aac\u660e<\/td>CD\u306b\u53ce\u8f09<\/td>\n<\/tr>\n
-<\/div><\/td>
Application for Accreditation of Foreign Manufacturers<\/td>Explanations to process of accreditation of foreign manufacturers and attached documents necessary to review<\/td>Listed in the CD<\/td>\n<\/tr>\n
\u5e73\u621018.02.14
\n
\n\u539a\u751f\u52b4\u50cd\u7701\u533b\u85ac\u98df\u54c1\u5c40\u5be9\u67fb\u7ba1\u7406\u8ab2\uff08\u4e8b\u52d9\u9023\u7d61\uff09<\/td>		\u5916\u56fd\u88fd\u9020\u696d\u8005\u8a8d\u5b9a\u306b\u95a2\u3059\u308b\u8cea\u7591\u5fdc\u7b54\u96c6\uff08Q\uff06A\uff09\u306b\u3064\u3044\u3066\uff08\u629c\u3059\u3044\uff09<\/td>\u69cb\u9020\u8a2d\u5099\u4e00\u89a7\u30fb\u8a3a\u65ad\u66f8<\/td>CD\u306b\u53ce\u8f09<\/td>\n<\/tr>\n
February 14,2006
\n
\nOffice Memorandum<\/td>		Questions and Answers (Q & A) on Accreditation of Foreign Manufacturers (Excerpt)<\/td>Outline of buildings and facilities\/medical certificate<\/td>Listed in the CD<\/td>\n<\/tr>\n
\u5e73\u621019.03.30
\n
\n\u85ac\u98df\u767a\u7b2c0330012\u53f7<\/td>		\u85ac\u4e8b\u6cd5\u65bd\u884c\u898f\u5247\u306e\u4e00\u90e8\u3092\u6539\u6b63\u3059\u308b\u7701\u4ee4\u306e\u65bd\u884c\u306b\u3064\u3044\u3066<\/td>\u8a3a\u65ad\u66f8\u306b\u4ee3\u308f\u308b\u758e\u660e\u66f8<\/td>CD\u306b\u53ce\u8f09<\/td>\n<\/tr>\n
March 30,2007
\n
\nPFSB Notification No.0330012<\/td>		Enforcement of the Ministerial Ordinance on the Partial Revision of Pharmaceutical Affairs Law Enforcement Regulations<\/td>Prima-facie evidence in Place of medical certificate<\/td>Listed in the CD<\/td>\n<\/tr>\n
\u5e73\u621019.06.19
\n
\n\u85ac\u98df\u767a\u7b2c0619002\u53f7<\/td>		\u533b\u85ac\u54c1\u7b49\u306e\u88fd\u9020\u696d\u306e\u8a31\u53ef\u53ca\u3073\u5916\u56fd\u88fd\u9020\u696d\u8005\u306e\u8a8d\u5b9a\u306e\u7533\u8acb\u306b\u6dfb\u4ed8\u3059\u308b\u69d8\u5f0f\u7b49\u306b\u3064\u3044\u3066<\/td>\u69cb\u9020\u8a2d\u5099\u4e00\u89a7\u306e\u4e00\u89a7\u8868
\n\u4ed6\u306e\u8a66\u9a13\u691c\u67fb\u6a5f\u95a2\u7b49\u306e\u5229\u7528\u6982\u8981<\/td>		CD\u306b\u53ce\u8f09<\/td>\n<\/tr>\n
June 19,2007
\n
\nPFSB Notification No.0619002<\/td>		Forms to be Attached to Applications for Manufacturing License of Pharmaceuticals, etc. and Accreditation of Foreign Manufacturer<\/td>Outline of buildings and facilities utilization of other testing and inspection facilities<\/td>Listed in the CD<\/td>\n<\/tr>\n
\u5e73\u621021.03.27
\n
\n\u653f\u4ee4\u7b2c61\u53f7<\/td>		\u85ac\u4e8b\u6cd5\u95a2\u4fc2\u624b\u6570\u6599\u4ee4\u306e \u4e00\u90e8\u6539\u6b63\u3059\u308b\u653f\u4ee4 (\u629c\u3059\u3044\uff09<\/td>\u5916\u56fd\u88fd\u9020\u696d\u8005\u8a8d\u5b9a\u30fb\u66f4\u65b0\u7b49\u624b\u6570\u6599\u91d1<\/td>CD\u306b\u53ce\u8f09<\/td>\n<\/tr>\n
March 27,2009
\n
\nCabinet Order No.61<\/td>		Cabinet Order for Fees Related to the Pharmaceutical Affairs Law (Excerpt) <\/td>Fees of application and renewal to accreditation of foreign manufacturer<\/td>Listed in the CD<\/td>\n<\/tr>\n
\u5e73\u621022.10.08
\n
\n\u85ac\u98df\u5be9\u67fb\u767a1008\u7b2c1\u53f7<\/td>		\u533b\u85ac\u54c1\u53ca\u3073\u533b\u85ac\u90e8\u5916\u54c1\u306b\u95a2\u3059\u308b
\n\u5916\u56fd\u88fd\u9020\u696d\u8005\u306e\u8a8d\u5b9a\u7533\u8acb\u306e\u53d6\u6271\u3044\u306b\u3064\u3044\u3066<\/td>		\u5916\u56fd\u88fd\u9020\u696d\u8005\u306e\u8a8d\u5b9a\u7533\u8acb\u306b\u6dfb\u4ed8\u3059\u3079\u304d\u8cc7\u6599\u306e
\n\u7559\u610f\u4e8b\u9805\u3001\u624b\u7d9a\u304d\u4ee3\u884c\u8005\u306b\u3064\u3044\u3066\u3001\u305d\u306e\u4ed6
\n\u7559\u610f\u4e8b\u9805\u306b\u3064\u3044\u3066<\/td>		CD\u306b\u53ce\u8f09<\/td>\n<\/tr>\n
October 8,2010
\n
\nPFSB\/ELD Notification 1008 No.1<\/td>		Handling of Applications for Accreditation of Foreign Manufacturers of Drug and Quansi-Drugs<\/td>Points to note regarding documents to be attached to applications for accreditation of foreign Manufacturers, Accreditation procedures followed by an agent, and other points to note<\/td>Listed in the CD<\/td>\n<\/tr>\n
\u5e73\u621022.10.13
\n
\n\u85ac\u98df\u767a1013\u7b2c2\u53f7<\/td>		\u533b\u85ac\u54c1\u7b49\u306e\u88fd\u9020\u696d\u306e\u8a31\u53ef\u53ca\u3073
\n\u5916\u56fd\u88fd\u9020\u696d\u8005\u306e\u8a8d\u5b9a\u306e\u7533\u8acb\u66f8\u306b\u6dfb\u4ed8\u3059\u308b\u69d8\u5f0f\u7b49\u306e\u6539\u6b63\u306b\u3064\u3044\u3066<\/td>		\u5e73\u621019\u5e746\u670819\u65e5\u4ed8\u3051\u85ac\u98df\u767a\u7b2c0619002\u53f7
\n\u539a\u751f\u52b4\u50cd\u7701\u533b\u85ac\u98df\u54c1\u5c40\u9577\u901a\u77e5\u306e\u4e00\u90e8\u6539\u6b63<\/td>		CD\u306b\u53ce\u8f09<\/td>\n<\/tr>\n
October 13, 2010
\n
\nPFSB Notification
\n1013 No.2<\/td>		Revision of Forms to be Attached to Applications for Authorization of Manufacture of Pharmaceuticals, etc and Accreditation of Foreign Manufacturers<\/td>Revise a part of the Director-General\u2019s Notification(PFSB Notification No.0619002, dated June 19, 2007),
\nForms of \"Outline of Buildings and Facilities\", \"Utilization of other Testing and Inspection Facilities\" and \u201cOutline of Buildings and Facilities for Sterile Products\u201d<\/td>		Listed in the CD<\/td>\n<\/tr>\n
\u69d8\u5f0f
\nForms<\/td>		\u5916\u56fd\u88fd\u9020\u696d\u8005\u3000\u8a8d\u5b9a\u7533\u8acb\u66f8\uff08\u69d8\u5f0f\u7b2c18\uff09
\nApplication for accreditation of foreign drug manufacturer(Form No. 18 (related to Article 35))<\/td>		CD\u306b\u53ce\u8f09
\nListed in the CD<\/td>\n<\/tr>\n
\u5916\u56fd\u88fd\u9020\u696d\u8005\u3000\u8a8d\u5b9a(\u8a8d\u5b9a\u306e\u66f4\u65b0)\u8abf\u67fb\u7533\u8acb\u66f8\uff08\u69d8\u5f0f\u7b2c16\uff082\uff09\uff09
\nApplication for examination for accreditation(accreditation renewal) of foreign drug manufacturerForm No. 16 (2) (related to Article 33)<\/td>		CD\u306b\u53ce\u8f09
\nListed in the CD<\/td>\n<\/tr>\n
\u5916\u56fd\u88fd\u9020\u696d\u8005\u3000\u8a8d\u5b9a\u66f4\u65b0\u7533\u8acb\u66f8\uff08\u69d8\u5f0f\u7b2c20\uff09 Application for accreditation renewal of foreign drugmanufacturer(Form No. 20 (related to Article 37))<\/td>CD\u306b\u53ce\u8f09
\nListed in the CD<\/td>\n<\/tr>\n
\u5916\u56fd\u88fd\u9020\u696d\u8005\u8a8d\u5b9a\u533a\u5206\u5909\u66f4\uff08\u8ffd\u52a0\uff09\u7533\u8acb\u66f8\uff08\u69d8\u5f0f\u7b2c21\uff09
\nApplication for change(addition) in accreditation category of foreign drug manufacturer Form No. 21 (related to Article 37)<\/td>		CD\u306b\u53ce\u8f09
\nListed in the CD<\/td>\n<\/tr>\n
\u5225\u6dfb1\u3000\u3010\u81ea\u5df1\u5ba3\u8a93\u66f8\u3011
\nSELF-DECLARATION BY MANAGERS OF FOREIGN MANUFACTURING FACILITIES<\/td>		CD\u306b\u53ce\u8f09
\nListed in the CD<\/td>\n<\/tr>\n
\u5225\u6dfb2\u3000\u3010\u88fd\u9020\u6240\u306e\u8cac\u4efb\u8005\u306e\u5c65\u6b74\u3011
\nPersonal History of Responsible Person<\/td>		CD\u306b\u53ce\u8f09
\nListed in the CD<\/td>\n<\/tr>\n
\u5225\u7d19\u69d8\u5f0f\u3010\u88fd\u9020\u54c1\u76ee\u306e\u4e00\u89a7\u53ca\u3073\u88fd\u9020\u5de5\u7a0b\u306b\u95a2\u3059\u308b\u66f8\u985e\u3011
\nProduct & Process List<\/td>		CD\u306b\u53ce\u8f09
\nListed in the CD<\/td>\n<\/tr>\n
\u69d8\u5f0f\uff082\uff09-1\u3000\u69cb\u9020\u8a2d\u5099\u306e\u6982\u8981\u4e00\u89a7\u8868
\nForm(2)-1 Outline of Buildings and Facilities<\/td>		CD\u306b\u53ce\u8f09
\nListed in the CD<\/td>\n<\/tr>\n
\u69d8\u5f0f\uff082\uff09-2\u3000\u4ed6\u306e\u8a66\u9a13\u691c\u67fb\u6a5f\u95a2\u7b49\u306e\u5229\u7528\u6982\u8981
\nForm(2)-2 Utilization of other Testing and Inspection Facilities<\/td>		CD\u306b\u53ce\u8f09
\nListed in the CD<\/td>\n<\/tr>\n
\u69d8\u5f0f\uff082\uff09-3\u3000\u7121\u83cc\u88fd\u5264\u4f5c\u696d\u6240\u306e\u69cb\u9020\u8a2d\u5099\u306e\u6982\u8981
\nForm(2)-3 Outline of Buildings and Facilities for Sterile Products<\/td>		CD\u306b\u53ce\u8f09
\nListed in the CD<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n\n

<\/a><\/p>\n

\u3010\u627f\u8a8d\u95a2\u4fc2\uff0fAPPROVAL\u3011<\/h3>\n\n\n\n\n\t\n\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t
\u65e5\u4ed8\/
\n\u767a\u51fa\u756a\u53f7<\/th>		\u901a\u77e5\u7b49\u4ef6\u540d<\/th>\u901a\u77e5\u5185\u5bb9<\/th>\u901a\u77e5URL<\/th>\n<\/tr>\n<\/thead>\n
Dated\/
\nNotification No.<\/sapn><\/td>		Title<\/td>Contents<\/td>URL of notification<\/td>\n<\/tr>\n
\u5e73\u621017.02.10
\n
\n\u85ac\u98df\u5be9\u67fb\u767a\u7b2c0210001\u53f7<\/td>		\u6539\u6b63\u85ac\u4e8b\u6cd5\u306b\u57fa\u3065\u304f\u533b\u85ac\u54c1\u7b49\u306e\u88fd\u9020\u8ca9\u58f2\u627f\u8a8d\u7533\u8acb\u66f8\u8a18\u8f09\u4e8b\u9805\u306b\u95a2\u3059\u308b\u6307\u91dd\u306b\u3064\u3044\u3066<\/td>\u539f\u85ac\u306e\u88fd\u9020\u65b9\u6cd5\u306e\u627f\u8a8d\u66f8\u8a18\u8f09\u8981\u9818
\n<\/td>		CD\u306b\u53ce\u8f09<\/td>\n<\/tr>\n
February 10,2005
\n
\nPFSB\/ELD Notification No.0210001<\/td>		Guideline for Descriptions on Application Forms Marketing Approval of Pharmaceuticals,etc. under the Revised Pharmaceutical Affairs Law<\/td>Descriptive guidelines on certificate of approval for API manufacturing method<\/td>Listed in the CD<\/td>\n<\/tr>\n
\u5e73\u621017.02.10
\n
\n\u85ac\u98df\u5be9\u67fb\u767a\u7b2c0210001\u53f7<\/td>		\u5225\u6dfb\uff11
\n\u5316\u5b66\u85ac\u54c1\u539f\u85ac\u306e\u88fd\u9020\u65b9\u6cd5\u306e\u627f\u8a8d\u7533\u8acb\u66f8\u8a18\u8f09\u8981\u9818<\/td>		\u539f\u85ac\u306e\u88fd\u9020\u65b9\u6cd5\u306e\u627f\u8a8d\u66f8\u8a18\u8f09\u4f8b<\/td>CD\u306b\u53ce\u8f09<\/td>\n<\/tr>\n
February 10,2005
\n
\nPFSB\/ELD Notification No.0210001<\/td>		Attachment1
\nChemical Drug Substance Manufacturing Method License Application Format Description Guidelines<\/td>		Examples of descriptive guidelines on certificate of approval for API manufacturing method<\/td>Listed in the CD<\/td>\n<\/tr>\n
\u5e73\u621017.02.10
\n
\n\u85ac\u98df\u5be9\u67fb\u767a\u7b2c0210001\u53f7<\/td>		\u5225\u6dfb\uff14
\n\u88fd\u9020\u5de5\u7a0b\u6d41\u308c\u56f3\uff08\u539f\u85ac\uff09<\/td>		\u539f\u85ac\u306e\u88fd\u9020\u65b9\u6cd5\u306e\u627f\u8a8d\u66f8\u8a18\u8f09\u4f8b<\/td>CD\u306b\u53ce\u8f09<\/td>\n<\/tr>\n
February 10,2005
\n
\nPFSB\/ELD Notification No.0210001<\/td>		Attachment4
\nFlow Diagram of Manufacturing Processes(Drug Substance)<\/td>		Examples of descriptive guidelines on certificate of approval for API manufacturing method<\/td>Listed in the CD<\/td>\n<\/tr>\n
\u5e73\u621017.03.23
\n
\n\u56fd\u7acb\u533b\u85ac\u54c1\u98df\u54c1\u885b\u751f\u7814\u7a76\u6240\u539a\u751f\u52b4\u50cd\u79d1\u5b66\u7814\u7a76\u73ed<\/td>		\u627f\u8a8d\u7533\u8acb\u66f8\u8a18\u8f09\u4f8b\u89e3\u8aac<\/td>\u901a\u77e5\u7b2c0210001\u53f7\u306e\u89e3\u8aac<\/td>CD\u306b\u53ce\u8f09<\/td>\n<\/tr>\n
March 23,2005
\n
\nNational Institute of Health Sciences <\/td>		Examples of Descriptions for Approval Application<\/td>Comments on Notification No.0210001<\/td>Listed in the CD<\/td>\n<\/tr>\n
\u5e73\u621022.06.28
\n
\n\u539a\u751f\u52b4\u50cd\u7701\u533b\u85ac\u98df\u54c1\u5c40\u5be9\u67fb\u7ba1\u7406\u8ab2\uff08\u4e8b\u52d9\u9023\u7d61\uff09<\/td>		\u8efd\u5fae\u5909\u66f4\u5c4a\u51fa\u306e\u7bc4\u56f2\u306e\u660e\u78ba\u5316\u306b
\n\u95a2\u3059\u308b\u691c\u8a0e\u7d50\u679c\u306b\u3064\u3044\u3066<\/td>		\u8efd\u5fae\u306a\u5909\u66f4\u3068\u3057\u3066\u306e\u5c4a\u51fa\u3067\u5bfe\u5fdc\u53ef\u80fd\u306a\u5909\u66f4\u306e
\n\u7bc4\u56f2\u306b\u3064\u3044\u3066<\/td>		CD\u306b\u53ce\u8f09<\/td>\n<\/tr>\n
June 28,2010
\n
\nOffice Memorandum<\/td>		Results of Consideration to Clarify the scope of a Minor Change Notification<\/td>The scope of change acceptable as the Notification of a minor change.<\/td>Listed in the CD<\/td>\n<\/tr>\n
\u5e73\u621023.06.16
\n
\n\u85ac\u98df\u5be9\u67fb\u767a0616\u7b2c1\u53f7<\/td>		\u7570\u306a\u308b\u7d50\u6676\u5f62\u7b49\u3092\u6709\u3059\u308b\u533b\u7642\u7528\u533b\u85ac\u54c1\u306e\u53d6\u6271\u3044\u306b\u3064\u3044\u3066<\/td>\u4e00\u822c\u7684\u540d\u79f0\u306b\u304a\u3051\u308b\u53d6\u6271\u3044\u3001\u7570\u306a\u308b\u7d50\u6676\u5f62\u7b49\u3092\u6709\u3059\u308b\u533b\u85ac\u54c1\u306e\u627f\u8a8d\u7533\u8acb\uff08\u5be9\u67fb\uff09\u4e0a\u306e\u53d6\u6271\u3044\u3001\u4e00\u822c\u7684\u540d\u79f0\uff08\uff2a\uff21\uff2e\uff09\u306e\u547d\u540d\u7533\u8acb\u7b49\u306b\u3064\u3044\u3066<\/td>\u672a\u53ce\u8f09<\/td>\n<\/tr>\n
June 16,2011
\n
\nPFSB\/ELD Notification No.0616-1<\/td>		Handling of Ethical Drugs That Have Differing Crystalline Forms, etc<\/td>Handling in nonproprietary names, Handling in applications for approval(review) drugs that have differing crystalline forms etc. and Application for the naming of nonproprietary names(JAN).<\/td>Not<\/font> listed in the CD<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n\n

<\/a><\/p>\n

\u3010\uff27\uff2d\uff30\u95a2\u4fc2\uff0fGMP\u3011<\/h3>\n\n\n\n\n\t\n\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t
\u65e5\u4ed8\/
\n\u767a\u51fa\u756a\u53f7<\/th>		\u901a\u77e5\u7b49\u4ef6\u540d<\/th>\u901a\u77e5\u5185\u5bb9<\/th>\u901a\u77e5URL<\/th>\n<\/tr>\n<\/thead>\n
Dated\/
\nNotification No.<\/sapn><\/td>		Title<\/td>Contents<\/td>URL of notification<\/td>\n<\/tr>\n
\u5e73\u621016.09.22
\n
\n\u85ac\u98df\u767a\u7b2c0922005\u53f7<\/td>		\u533b\u85ac\u54c1\u3001\u533b\u85ac\u90e8\u5916\u54c1\u3001\u5316\u7ca7\u54c1\u53ca\u3073 \u533b\u7642\u6a5f\u5668\u306e\u88fd\u9020\u8ca9\u58f2\u5f8c\u5b89\u5168\u7ba1\u7406\u306e\u57fa\u6e96\u306b\u95a2\u3059\u308b\u7701\u4ee4\u53ca\u3073\u85ac\u4e8b\u6cd5\u65bd\u884c\u898f\u5247\u306e\u4e00\u90e8\u3092\u6539\u6b63\u3059\u308b\u7701\u4ee4\u306e\u65bd\u884c\u306b\u3064\u3044\u3066 <\/td>
-<\/div><\/td>
CD\u306b\u53ce\u8f09<\/td>\n<\/tr>\n
September 22,2004
\n
\nPFSB Notification
\nNo.0922005<\/td>		Partial Revision of Ministerial Ordinance on Standards for Post Marketing of Safety Assureance for Drugs, Quasi-drugs, Cosmetics and Medical Devices<\/td>
-<\/div><\/td>
Listed in the CD(but Japanese only, No translation in English)<\/td>\n<\/tr>\n
\u5e73\u621017.03.30
\n
\n\u85ac\u98df\u76e3\u9ebb\u767a\u7b2c0330001\u53f7<\/td>		\u85ac\u4e8b\u6cd5\u53ca\u3073\u63a1\u8840\u53ca\u3073\u4f9b\u8840\u3042\u3063\u305b\u3093\u696d\u53d6\u7de0\u6cd5\u306e\u4e00\u90e8\u3092\u6539\u6b63\u3059\u308b\u6cd5\u5f8b\u306e\u65bd\u884c\u306b\u4f34\u3046\u533b\u85ac\u54c1\u3001\u533b\u7642\u6a5f\u5668\u7b49\u306e\u88fd\u9020\u7ba1\u7406\u53ca\u3073\u54c1\u8cea\u7ba1\u7406\uff08GMP\/QMS\uff09\u306b\u4fc2\u308b\u7701\u4ee4\u53ca\u3073\u544a\u793a\u306e\u5236\u5b9a\u53ca\u3073\u6539\u5ec3\u306b\u3064\u3044\u3066<\/td>\u6539\u6b63\u6cd5\u306e\u904b\u7528\u306e\u9010\u6761\u89e3\u8aac
\n<\/td>		CD\u306b\u53ce\u8f09<\/td>\n<\/tr>\n
March 30,2005
\n
\nPFSB\/CND Notification No.0330001<\/td>		-<\/td>Explanations to revised law operation article by article<\/td>Listed in the CD(but Japanese only, No translation in English)<\/td>\n<\/tr>\n
\u5e73\u621016.12.17
\n
\n\u7701\u4ee4\u7b2c169\u53f7<\/td>		\u533b\u7642\u6a5f\u5668\u53ca\u3073\u4f53\u5916\u8a3a\u65ad\u7528\u533b\u85ac\u54c1\u306e\u88fd\u9020\u7ba1\u7406 \u53ca\u3073\u54c1\u8cea\u7ba1\u7406\u306e\u57fa\u6e96\u306b\u95a2\u3059\u308b\u7701\u4ee4 <\/td>
-<\/div><\/td>
CD\u306b\u53ce\u8f09<\/td>\n<\/tr>\n
December 17,2004
\n
\nMHLW Ministerial Ordinance No.169<\/td>		Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Medical Devices and In-vitro Diagnostic Reagents<\/td>
-<\/div><\/td>
Listed in the CD<\/td>\n<\/tr>\n
\u5e73\u621016.12.24
\n
\n\u7701\u4ee4\u7b2c179\u53f7<\/td>		\u533b\u85ac\u54c1\u53ca\u3073\u533b\u85ac\u90e8\u5916\u54c1\u306e\u88fd\u9020\u7ba1\u7406\u53ca\u3073\u54c1\u8cea\u7ba1\u7406\u306e\u57fa\u6e96\u306b\u95a2\u3059\u308b\u7701\u4ee4<\/td>
-<\/div><\/td>
CD\u306b\u53ce\u8f09<\/td>\n<\/tr>\n
December 24, 2004
\n
\nMHLW Ministerial Ordinance No.179<\/td>		Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Drugs and Quasi-drugs <\/td>
-<\/div><\/td>
Listed in the CD<\/td>\n<\/tr>\n
\u5e73\u621016.12.24
\n
\n\u7701\u4ee4\u7b2c180\u53f7<\/td>		\u85ac\u5c40\u7b49\u69cb\u9020\u8a2d\u5099\u898f\u5247\u306e\u4e00\u90e8\u3092\u6539\u6b63\u3059\u308b\u7701\u4ee4<\/td>
-<\/div><\/td>
CD\u306b\u53ce\u8f09<\/td>\n<\/tr>\n
December 24, 2004
\n
\nMHLW Ministerial Ordinance No.180<\/td>		Regulations\u3000for Buildings and Facilities of Pharmacies, etc.<\/td>
-<\/div><\/td>
Listed in the CD<\/td>\n<\/tr>\n
\u5e73\u621017.09.09
\n
\n\u539a\u751f\u52b4\u50cd\u7701\u533b\u85ac\u98df\u54c1\u5c40\u76e3\u8996\u6307\u5c0e\u30fb\u9ebb\u85ac\u5bfe\u7b56\u8ab2\uff08\u4e8b\u52d9\u9023\u7d61\uff09<\/td>		GQP\u7701\u4ee4\u3001\u533b\u85ac\u54c1\u30fb\u533b\u85ac\u90e8\u5916\u54c1\u306eGMP\u7701\u4ee4\u3001\u6a5f\u5668\u30fb\u4f53\u5916\u8a3aQMS\u7701\u4ee4\u53ca\u3073\u69cb\u9020\u8a2d\u5099\u898f\u5247\u306e\u4eee\u82f1\u8a33\u306b\u3064\u3044\u3066<\/td>
-<\/div><\/td>
CD\u306b\u53ce\u8f09<\/td>\n<\/tr>\n
September 9,2005
\n
\nOffice Memorandum<\/td>		GQP Ministerial Ordinance, GMP Ministerial Ordinance on Drugs and Quasi-drugs, GMS Ministerial Ordinance on Medical Devices and In Vitro Diagnostics, and Regulations for Buildings and Facilities<\/td>
-<\/div><\/td>
Listed in the CD<\/td>\n<\/tr>\n
\u5e73\u621023.6.21
\n
\n\u539a\u751f\u52b4\u50cd\u7701\u533b\u85ac\u98df\u54c1\u5c40
\n\u5be9\u67fb\u7ba1\u7406\u8ab2
\n\u76e3\u8996\u6307\u5c0e\u30fb\u9ebb\u85ac\u5bfe\u7b56\u8ab2
\n\uff08\u4e8b\u52d9\u9023\u7d61\uff09<\/td>		\u88fd\u9020\u6240\u5909\u66f4\u8fc5\u901f\u5be9\u67fb\u306e\u7533\u8acb\u6642\u306b\u6dfb\u4ed8\u3059\u3079\u304d\u8cc7\u6599\u7b49\u306e\u6539\u6b63\u306b\u3064\u3044\u3066<\/td>GMP\u8abf\u67fb\u6a29\u8005\u304c\uff08\u72ec\uff09\u533b\u85ac\u54c1\u533b\u7642\u6a5f\u5668\u7dcf\u5408\u6a5f\u69cb\u3067\u3042\u308b\u5834\u5408\u306b\u304a\u3051\u308bGMP\u9069\u5408\u6027\u8abf\u67fb\u7533\u8acb\u306e
\n\u6dfb\u4ed8\u8cc7\u6599\u306e\u3046\u3061\u3001\u6dfb\u4ed8\u8cc7\u6599\u306e\u6ce8\u610f\u70b9\u3092\u793a\u3057\u305f
\n\u5225\u7d19\u306e\u8a18\u8f09\u306e\u4e00\u90e8\u6539\u6b63\u3001\u53ca\u3073\u5f53\u8a72\u88fd\u9020\u6240\u306b\u304a\u3051\u308b\u8abf\u67fb\u5bfe\u8c61\u54c1\u76ee\u7b49\u306b\u95a2\u3059\u308b\u6982\u8981\u306e\u8ffd\u52a0\u3001
\n\u56fd\u5185\u88fd\u9020\u6240\u306e\u6982\u8981\u53ca\u3073\u5916\u56fd\u88fd\u9020\u6240\u306e\u6982\u8981\u3092
\n\u8a18\u8f09\u3059\u308b\u5225\u7d19\u69d8\u5f0f\u306e\u8a18\u8f09\u60c5\u5831\u306e\u8ffd\u52a0\u7b49\u3002<\/td>		CD\u306b\u53ce\u8f09<\/td>\n<\/tr>\n
June 21,2011
\n
\nOffice Memorandum<\/td>		Amendments in Documents to be Attached to the Application for Expedited Review of Changes of Drug Manufacturing Site<\/td>The description in the exhibit, indicating notes for the attached documents, has been revised in the attached documents for application for a GMP compliance inspection when the GMP inspection authority is the PMDA. In addition, an overview of the products subject to manufacturing site inspection has been added, and exhibit forms to describe the outline for domestic manufacturing sites and the outline for foreign manufacturing sites have been amended to add information to be described.<\/td>Listed in the CD<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n\n

<\/a><\/p>\n

\u3010\uff27\uff2d\uff30\u9069\u5408\u6027\u8abf\u67fb\u95a2\u4fc2\uff0fGMP Compliance Inspection\u3011<\/h3>\n\n\n\n\n\t\n\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t
\u65e5\u4ed8\/
\n\u767a\u51fa\u756a\u53f7<\/th>		\u901a\u77e5\u7b49\u4ef6\u540d<\/th>\u901a\u77e5\u5185\u5bb9<\/th>\u901a\u77e5URL<\/th>\n<\/tr>\n<\/thead>\n
Dated\/
\nNotification No.<\/sapn><\/td>		Title<\/td>Contents<\/td>URL of notification<\/td>\n<\/tr>\n
\u5e73\u621017.03.30
\n
\n\u85ac\u98df\u5be9\u67fb\u767a\u7b2c0330006\u53f7
\n\u85ac\u98df\u76e3\u9ebb\u767a\u7b2c0330005\u53f7<\/td>		GMP\u9069\u5408\u6027\u8abf\u67fb\u7533\u8acb\u306e\u53d6\u6271\u3044\u306b\u3064\u3044\u3066<\/td>\u5236\u5ea6\u306e\u89e3\u8aac\u30fb\u7533\u8acb\u65b9\u6cd5\u30fb\u8abf\u67fb\u306e\u65b9\u6cd5<\/td>CD\u306b\u53ce\u8f09
\n\uff08\u203b\u6ce8\u610f<\/font>\uff1a\u3053\u306e\u901a\u77e5\u306f\u3001\u5e73\u621027\u5e747\u67082\u65e5\u85ac\u98df\u5be9\u67fb\u767a0702\u7b2c1\u53f7\/\u85ac\u98df\u76e3\u9ebb\u767a0702\u7b2c1\u53f7\u300cGMP\u9069\u5408\u6027\u8abf\u67fb\u7533\u8acb\u306e\u53d6\u308a\u6271\u3044\u306b\u3064\u3044\u3066\u300d\u306e\u767a\u51fa\u306b\u4f34\u3044\u5ec3\u6b62<\/font>\u3055\u308c\u3066\u3044\u307e\u3059\u304c\u3001\u5909\u66f4\u5f8c\u306e\u901a\u77e5\u306fCD\u306b\u672a\u53ce\u8f09<\/font>\u3067\u3059\u3002)
\n<\/td>\n<\/tr>\n
March 30,2005
\n
\nPFSB\/ELD Notification No. 0330006
\nPFSB\/CND Notification No. 0330005<\/td>		Guidance on Application for GMP Compliance Review<\/td>Explanations to system \/ Application method \/ research method<\/td>Listed in the CD
\n\uff08\u203bAttention<\/font>\uff1aThis notification has been ceased after PFSB\/ELD Notification No. 0702-1 \/ PFSB\/CND Notification No. 0702-1 since \u201cGuidance on Handling of Application for GMP Compliance Inspection\u201c dated July 2nd 2015 has been issued.)<\/td>\n<\/tr>\n
\u5e73\u621020.07.29
\n
\n\uff08\u72ec\uff09\u533b\u85ac\u54c1\u533b\u7642\u6a5f\u5668
\n\u7dcf\u5408\u6a5f\u69cb \u54c1\u8cea\u7ba1\u7406\u90e8
\n(\u4e8b\u52d9\u9023\u7d61)<\/td>		\u533b\u85ac\u54c1\u9069\u5408\u6027\u8abf\u67fb\u7533\u8acb\u306b\u304a\u3044\u3066\u7dcf\u5408\u6a5f\u69cb\u304c\u5fc5\u8981\u3068\u3059\u308b\u8cc7\u6599\u306b\u3064\u3044\u3066<\/td>
-<\/div><\/td>
CD\u306b\u53ce\u8f09<\/td>\n<\/tr>\n
July 29,2008
\n
\nOffice Memorandum<\/td>		Documents required by PMDA for the Application of GMP Compliance Inspection <\/td>
-<\/div><\/td>
Listed in the CD<\/td>\n<\/tr>\n
\u69d8\u5f0f
\nForms<\/td>		\u69d8\u5f0f\u7b2c\u4e8c\u5341\u4e94\u3000\u533b\u85ac\u54c1\u9069\u5408\u6027\u8abf\u67fb\u7533\u8acb\u66f8
\nForm No. 25 (1) (in relation to Article 50)\u3000Application for GMP Compliance Review of Drugs\/Quasi Drugs<\/td>		CD\u306b\u53ce\u8f09
\nListed in the CD<\/td>\n<\/tr>\n
\u69d8\u5f0f\u7b2c\u4e8c\u5341\u516d\u3000\u533b\u85ac\u54c1\u9069\u5408\u6027\u8abf\u67fb\u7d50\u679c\u901a\u77e5\u66f8
\nForm No. 26 (1)\uff08in relation to Article 51, Article 55 and Article 263\uff09\u3000Drugs\u3000GMP Compliance Inspection Result Notification<\/td>		CD\u306b\u53ce\u8f09
\nListed in the CD<\/td>\n<\/tr>\n
\uff08\u3072\u306a\u5f62\uff09\uff27\uff2d\uff30\u8abf\u67fb\u7d50\u679c\u5831\u544a\u66f8
\n( Form- ) GMP Compliance Inspection Result Report<\/td>		CD\u306b\u53ce\u8f09
\nListed in the CD<\/td>\n<\/tr>\n
\u5e73\u621020.09.01
\n
\n\u2010<\/td>		\u5916\u56fd\u88fd\u9020\u696d\u8005\u306b\u5bfe\u3059\u308b\u533b\u85ac\u54c1GMP\u9069\u5408\u6027\u8abf\u67fb\u306b\u3064\u3044\u3066<\/td>\u5916\u56fd\u88fd\u9020\u696d\u8005\u5411\u3051\u6982\u8981\u8aac\u660e<\/td>CD\u306b\u53ce\u8f09<\/td>\n<\/tr>\n
September 1,2008
\n
\n\u2010<\/td>		GMP Compliance Inspection concerning pharmaceuticals (including APIs) of Foreign Manufacturers (Overview Guidance for Foreign Manufacturers)<\/td>Overview Guidance for foreign manufacturers<\/td>Listed in the CD<\/td>\n<\/tr>\n
\u69d8\u5f0f
\nForms<\/td>		\u69d8\u5f0f1\u3000\u5f53\u8a72\u88fd\u9020\u6240\u306b\u304a\u3051\u308b\u8abf\u67fb\u5bfe\u8c61\u54c1\u76ee\u306b\u95a2\u3059\u308b\u6982\u8981
\nForm 1\u3000Outline of Product(s) Subject to Inspection<\/td>		CD\u306b\u53ce\u8f09
\nListed in the CD<\/td>\n<\/tr>\n
\u69d8\u5f0f2\u3000\u533b\u85ac\u54c1\u88fd\u9020\u6240\u6982\u8981\uff08\u56fd\u5185\u88fd\u9020\u6240\u7528\uff09
\nOutline of Drug Manufacturing Site (Domestic Manufacturing Site)<\/td>		CD\u306b\u53ce\u8f09
\nListed in the CD<\/td>\n<\/tr>\n
\u69d8\u5f0f3\u3000\u533b\u85ac\u54c1\u88fd\u9020\u6240\u6982\u8981\uff08\u5916\u56fd\u88fd\u9020\u6240\u7528\uff09
\nForm 3\u3000Outline of Drug Manufacturing Site\u3000 (Foreign Manufacturing Site)<\/td>		CD\u306b\u53ce\u8f09
\nListed in the CD<\/td>\n<\/tr>\n
\u5e73\u621020.09.01
\n
\n\u2010<\/td>		GMP\u9069\u5408\u6027\u8abf\u67fb\u3067\u63d0\u51fa\u3059\u308b\u8cc7\u6599<\/td>
-<\/div><\/td>
CD\u306b\u53ce\u8f09<\/td>\n<\/tr>\n
September 1,2008
\n
\n\u2010<\/td>		Documents to be submitted for GMP Compliance Inspection<\/td>
-<\/div><\/td>
Listed in the CD<\/td>\n<\/tr>\n
\u5e73\u621022.10.25
\n
\n\uff08\u72ec\uff09\u533b\u85ac\u54c1\u533b\u7642\u6a5f\u5668
\n\u7dcf\u5408\u6a5f\u69cb\u54c1\u8cea\u7ba1\u7406\u90e8
\n(\u4e8b\u52d9\u9023\u7d61) <\/td>		\u5b9a\u671f\u8abf\u67fb\u306b\u4fc2\u308b\u533b\u85ac\u54c1\u9069\u5408\u6027\u8abf\u67fb\u6642\u306e\u63d0\u51fa\u8cc7\u6599\u306b\u3064\u3044\u3066<\/td>\u5b9a\u671f\u8abf\u67fb\u306e\u8abf\u67fb\u7533\u8acb\u6642\u306b\u63d0\u51fa\u3059\u308b\u8cc7\u6599\u306e\u898b\u76f4\u3057\u306b\u3064\u3044\u3066<\/td>CD\u306b\u53ce\u8f09<\/td>\n<\/tr>\n
October 25,2010
\n
\nOffice Memorandum<\/td>		Documents to be Submitted for Periodic GMP Compliance Inspection<\/td>Revision the documents to be submitted for application for periodic GMP compliance inspection.<\/td>Listed in the CD<\/td>\n<\/tr>\n
\u5e73\u621022.10.25
\n
\n\uff08\u72ec\uff09\u533b\u85ac\u54c1\u533b\u7642\u6a5f\u5668
\n\u7dcf\u5408\u6a5f\u69cb\u54c1\u8cea\u7ba1\u7406\u90e8
\n(\u4e8b\u52d9\u9023\u7d61)<\/td>		\u533b\u85ac\u54c1\u9069\u5408\u6027\u8abf\u67fb\u7533\u8acb\u306b\u304a\u3044\u3066\u7dcf\u5408\u6a5f\u69cb\u304c\u5fc5\u8981\u3068\u3059\u308b\u8cc7\u6599\u306e\u4e00\u90e8\u6539\u8a02\u306b\u3064\u3044\u3066<\/td>\u5e73\u621020\u5e747\u670829\u65e5\u4ed8\uff08\u72ec\uff09\u533b\u85ac\u54c1\u533b\u7642\u6a5f\u5668\u7dcf\u5408\u6a5f\u69cb\u54c1\u8cea\u7ba1\u7406\u90e8\u4e8b\u52d9\u9023\u7d61\u306e\u4e00\u90e8\u6539\u8a02\u3002
\n\u7dcf\u5408\u6a5f\u69cb\u306b\u63d0\u51fa\u8cc7\u6599\u306e\u69d8\u5f0f\uff08\u5f53\u8a72\u88fd\u9020\u6240\u306b\u304a\u3051\u308b\u8abf\u67fb\u5bfe\u8c61\u54c1\u76ee\u7b49\u306b\u95a2\u3059\u308b\u6982\u8981\u3001
\n\u533b\u85ac\u54c1\u88fd\u9020\u6240\u6982\u8981\uff08\u56fd\u5185\u88fd\u9020\u6240\u7528\uff09\u3001\u533b\u85ac\u54c1\u88fd\u9020\u6240\u6982\u8981\uff08\u6d77\u5916\u88fd\u9020\u6240\u7528\uff09\uff09\u306e\u6539\u8a02<\/td>		CD\u306b\u53ce\u8f09<\/td>\n<\/tr>\n
October 25,2010
\n
\nOffice Memorandum<\/td>		Partial Revision of Documents Required by PDMA for the Application of GMP Compliance Inspection<\/td>The Office Memorandum dated July 29, 2008 \u201cDocuments Required by PMDA for the Application of GMP Compliance Inspection.\u201d is to be partially(the form of the documents to be submitted) revised.<\/td>Listed in the CD<\/td>\n<\/tr>\n
\u5e73\u621023.6.21
\n
\n\u539a\u751f\u52b4\u50cd\u7701\u533b\u85ac\u98df\u54c1\u5c40
\n\u5be9\u67fb\u7ba1\u7406\u8ab2
\n\u76e3\u8996\u6307\u5c0e\u30fb\u9ebb\u85ac\u5bfe\u7b56\u8ab2
\n\uff08\u4e8b\u52d9\u9023\u7d61\uff09 <\/td>		\u88fd\u9020\u6240\u5909\u66f4\u8fc5\u901f\u5be9\u67fb\u306e\u7533\u8acb\u6642\u306b\u6dfb\u4ed8\u3059\u3079\u304d\u8cc7\u6599\u7b49\u306e\u6539\u6b63\u306b\u3064\u3044\u3066<\/td>GMP\u8abf\u67fb\u6a29\u8005\u304c\uff08\u72ec\uff09\u533b\u85ac\u54c1\u533b\u7642\u6a5f\u5668\u7dcf\u5408\u6a5f\u69cb\u3067\u3042\u308b\u5834\u5408\u306b\u304a\u3051\u308bGMP\u9069\u5408\u6027\u8abf\u67fb\u7533\u8acb\u306e
\n\u6dfb\u4ed8\u8cc7\u6599\u306e\u3046\u3061\u3001\u6dfb\u4ed8\u8cc7\u6599\u306e\u6ce8\u610f\u70b9\u3092\u793a\u3057\u305f
\n\u5225\u7d19\u306e\u8a18\u8f09\u306e\u4e00\u90e8\u6539\u6b63\u3001\u53ca\u3073\u5f53\u8a72\u88fd\u9020\u6240\u306b\u304a\u3051\u308b\u8abf\u67fb\u5bfe\u8c61\u54c1\u76ee\u7b49\u306b\u95a2\u3059\u308b\u6982\u8981\u306e\u8ffd\u52a0\u3001
\n\u56fd\u5185\u88fd\u9020\u6240\u306e\u6982\u8981\u53ca\u3073\u5916\u56fd\u88fd\u9020\u6240\u306e\u6982\u8981\u3092
\n\u8a18\u8f09\u3059\u308b\u5225\u7d19\u69d8\u5f0f\u306e\u8a18\u8f09\u60c5\u5831\u306e\u8ffd\u52a0\u7b49\u3002<\/td>		CD\u306b\u53ce\u8f09<\/td>\n<\/tr>\n
June 21,2011
\n
\nOffice Memorandum <\/td>		Amendments in Documents to be Attached to the Application for Expedited Review of Changes of Drug Manufacturing Site<\/td>The description in the exhibit, indicating notes for the attached documents, has been revised in the attached documents for application for a GMP compliance inspection when the GMP inspection authority is the PMDA. In addition, an overview of the products subject to manufacturing site inspection has been added, and exhibit forms to describe the outline for domestic manufacturing sites and the outline for foreign manufacturing sites have been amended to add information to be described.<\/td>Listed in the CD<\/td>\n<\/tr>\n
\u5e73\u621024\u5e742\u670816\u65e5
\n
\n\u85ac\u98df\u76e3\u9ebb\u767a0216\u7b2c7\u53f7<\/td>		GMP\u8abf\u67fb\u8981\u9818\u306e\u5236\u5b9a\u306b\u3064\u3044\u3066<\/td>GMP\u8abf\u67fb\u306e\u5206\u985e\u53ca\u3073\u6cd5\u7684\u6839\u62e0\u7b49\u306e\u8aac\u660e\u3001\u54c1\u8cea\u30de\u30cb\u30e5\u30a2\u30eb\u3001GMP\u8abf\u67fb\u306e\u5b9f\u65bd\u306b\u95a2\u3059\u308b\u624b\u9806\u7b49<\/td>CD\u306b\u53ce\u8f09<\/td>\n<\/tr>\n
February 16, 2012
\n
\nPFSB\/CND (Yakushoku-kanma) Notification No. 0216-7<\/td>		Establishment of Guidelines for GMP Inspections<\/td>The classification of the GMP inspections, the explanation of legal
\ngrounds, the quality manual that can be commonly used by each inspection authority, and the
\nprocedures for implementing the GMP inspections.<\/td>		Listed in the CD<\/td>\n<\/tr>\n
2012\u5e742\u670816\u65e5
\n
\n\u836f\u98df\u76d1\u9ebb\u53d1 0216 \u7b2c7\u53f7<\/td>		\u95a2\u4e8e\u8abf\u67fb\u8981\u9818\u7684\u5236\u5b9a<\/td>\u672c\u8981\u9818\u7531GMP\u8abf\u67fb\u5206\u985e\u53ca\u6cd5\u5f8b\u4f9d\u636e\u7684\u8aac\u660e\u3001\u5404\u8abf\u67fb\u6a29\u8005\u901a\u7528\u7684\u54c1\u8cea\u6307\u5357\u53caGMP\u8abf\u67fb\u5b9f\u65bd\u898f\u5b9a\u7b49\u90e8\u5206\u7d44\u6210\u3002<\/td>Listed in the CD
\n(Transleted in Chinese)<\/td>\n<\/tr>\n
\u5e73\u621025\u5e7412\u67082\u65e5
\n
\n\uff08\u72ec\uff09\u533b\u85ac\u54c1\u533b\u7642\u6a5f\u5668 \u7dcf\u5408\u6a5f\u69cb \u54c1\u8cea\u7ba1\u7406\u90e8
\n(\u4e8b\u52d9\u9023\u7d61)<\/td>		\u533b\u85ac\u54c1\u7b49\u9069\u5408\u6027\u8abf\u67fb\u306e\u7533\u8acb\u306b\u5f53\u305f\u3063\u3066\u63d0\u51fa\u3059\u3079\u304d\u8cc7\u6599\u306b\u3064\u3044\u3066<\/td>
-<\/div><\/td>
CD\u306b\u53ce\u8f09
\n\uff08\u203b\u6ce8\u610f<\/font>\uff1a\u3053\u306e\u901a\u77e5\u306f\u3001\u5e73\u621027\u5e746\u670818\u65e5\u4e8b\u52d9\u9023\u7d61\u300c\u533b\u85ac\u54c1\u7b49\u9069\u5408\u6027\u8abf\u67fb\u306e\u7533\u8acb\u306b\u5f53\u305f\u3063\u3066\u63d0\u51fa\u3059\u3079\u304d\u8cc7\u6599\u306b\u3064\u3044\u3066\u300d\u306e\u767a\u51fa\u306b\u4f34\u3044\u5ec3\u6b62<\/font>\u3055\u308c\u3066\u3044\u307e\u3059\u304c\u3001\u5909\u66f4\u5f8c\u306e\u901a\u77e5\u306fCD\u306b\u672a\u53ce\u8f09<\/font>\u3067\u3059\u3002)<\/td>\n<\/tr>\n
December 2,2013
\n
\nOffice of GMP\/QMS Inspection, PMDA
\nOffice Memorandum<\/td>		Documents to be submitted to PMDA when applying for its pre-approval GMP
\ninspection or periodic post-approval GMP inspection of drugs or quasi-drugs<\/td>
-<\/div><\/td>
Listed in the CD
\n\uff08\u203bAttention<\/font>\uff1aThis notification has been ceased after the administrative Notice of Manufacturing\/Quality and Compliance, Pharmaceuticals and Medical Devices Agency since \u201cSubmission Data for Application of Drug Compliance Inspection\u201c dated June 18th 2015 has been issued.)<\/td>\n<\/tr>\n
\u69d8\u5f0f
\nForms<\/td>		\u69d8\u5f0f1\u3000\u5f53\u8a72\u88fd\u9020\u6240\u306b\u304a\u3051\u308b\u8abf\u67fb\u5bfe\u8c61\u54c1\u76ee\u306b\u95a2\u3059\u308b\u6982\u8981
\nForm 1\u3000Outline of Product(s) Subject to Inspection<\/td>		CD\u306b\u53ce\u8f09
\nListed in the CD<\/td>\n<\/tr>\n
\u69d8\u5f0f3\u3000\u533b\u85ac\u54c1\u88fd\u9020\u6240\u6982\u8981\uff08\u5916\u56fd\u88fd\u9020\u6240\u7528\uff09
\nForm 3\u3000Outline of Drug Manufacturing Site\u3000 (Foreign Manufacturing Site)<\/td>		CD\u306b\u53ce\u8f09
\nListed in the CD<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n\n

<\/a><\/p>\n

\u3010\uff27\uff31\uff30\u95a2\u4fc2\uff0fGQP\u3011<\/h3>\n\n\n\n\n\t\n\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t
\u65e5\u4ed8\/
\n\u767a\u51fa\u756a\u53f7<\/th>		\u901a\u77e5\u7b49\u4ef6\u540d<\/th>\u901a\u77e5\u5185\u5bb9<\/th>\u901a\u77e5URL<\/th>\n<\/tr>\n<\/thead>\n
Dated\/
\nNotification No.<\/sapn><\/td>		Title<\/td>Contents<\/td>URL of notification<\/td>\n<\/tr>\n
\u5e73\u621016.09.22
\n
\n\u85ac\u98df\u767a\u7b2c0922005\u53f7<\/td>		\u533b\u85ac\u54c1\u3001\u533b\u85ac\u90e8\u5916\u54c1\u3001\u5316\u7ca7\u54c1\u53ca\u3073 \u533b\u7642\u6a5f\u5668\u306e\u88fd\u9020\u8ca9\u58f2\u5f8c\u5b89\u5168\u7ba1\u7406\u306e\u57fa\u6e96\u306b\u95a2\u3059\u308b\u7701\u4ee4\u53ca\u3073\u85ac\u4e8b\u6cd5\u65bd\u884c\u898f\u5247\u306e\u4e00\u90e8\u3092\u6539\u6b63\u3059\u308b\u7701\u4ee4\u306e\u65bd\u884c\u306b\u3064\u3044\u3066<\/td>
-<\/div><\/td>
CD\u306b\u53ce\u8f09<\/td>\n<\/tr>\n
September 22,2004
\n
\nPFSB Notification
\nNo.0922005<\/td>		Partial Revision of Ministerial Ordinance on Standards for Post Marketing of Safety Assureance for Drugs, Quasi-drugs, Cosmetics and Medical Devices<\/td>
-<\/div><\/td>
Listed in the CD(but Japanese only, No translation in English)<\/td>\n<\/tr>\n
\u5e73\u621017.03.30
\n
\n\u85ac\u98df\u76e3\u9ebb\u767a\u7b2c0330001\u53f7<\/td>		\u85ac\u4e8b\u6cd5\u53ca\u3073\u63a1\u8840\u53ca\u3073\u4f9b\u8840\u3042\u3063\u305b\u3093\u696d\u53d6\u7de0\u6cd5\u306e\u4e00\u90e8\u3092\u6539\u6b63\u3059\u308b\u6cd5\u5f8b\u306e\u65bd\u884c\u306b\u4f34\u3046\u533b\u85ac\u54c1\u3001\u533b\u7642\u6a5f\u5668\u7b49\u306e\u88fd\u9020\u7ba1\u7406\u53ca\u3073\u54c1\u8cea\u7ba1\u7406\uff08GMP\/QMS\uff09\u306b\u4fc2\u308b\u7701\u4ee4\u53ca\u3073\u544a\u793a\u306e\u5236\u5b9a\u53ca\u3073\u6539\u5ec3\u306b\u3064\u3044\u3066<\/td>\u6539\u6b63\u6cd5\u306e\u904b\u7528\u306e\u9010\u6761\u89e3\u8aac<\/td>CD\u306b\u53ce\u8f09<\/td>\n<\/tr>\n
March 30,2005
\n
\nPFSB\/CND Notification No.0330001<\/td>
-<\/div><\/td>
Explanations to revised law operation article by article<\/td>Listed in the CD(but Japanese only, No translation in English)<\/td>\n<\/tr>\n
\u5e73\u621016.09.22
\n
\n\u7701\u4ee4\u7b2c136\u53f7<\/td>		\u533b\u85ac\u54c1\u30fb\u533b\u85ac\u90e8\u5916\u54c1\u3001\u5316\u7ca7\u54c1\u53ca\u3073\u533b\u7642\u6a5f\u5668\u306e\u54c1\u8cea\u7ba1\u7406\u306e\u57fa\u6e96\u306b\u95a2\u3059\u308b\u7701\u4ee4<\/td>
-<\/div><\/td>
CD\u306b\u53ce\u8f09<\/td>\n<\/tr>\n
September 22,2004
\n
\nMHLW Ministerial Ordinance No.136<\/td>		Ministerial Ordinance on Standards for Quality Assurance for Drugs,\u3000Quasi-drugs, Cosmetics and Medical Devices<\/td>
-<\/div><\/td>
Listed in the CD<\/td>\n<\/tr>\n
\u5e73\u621017.09.09
\n
\n\u539a\u751f\u52b4\u50cd\u7701\u533b\u85ac\u98df\u54c1\u5c40\u76e3\u8996\u6307\u5c0e\u30fb\u9ebb\u85ac\u5bfe\u7b56\u8ab2\uff08\u4e8b\u52d9\u9023\u7d61\uff09<\/td>		GQP\u7701\u4ee4\u3001\u533b\u85ac\u54c1\u30fb\u533b\u85ac\u90e8\u5916\u54c1\u306eGMP\u7701\u4ee4\u3001\u6a5f\u5668\u30fb\u4f53\u5916\u8a3aQMS\u7701\u4ee4\u53ca\u3073\u69cb\u9020\u8a2d\u5099\u898f\u5247\u306e\u4eee\u82f1\u8a33\u306b\u3064\u3044\u3066<\/td>
-<\/div><\/td>
CD\u306b\u53ce\u8f09<\/td>\n<\/tr>\n
September 9,2005
\n
\nOffice Memorandum<\/td>		GQP Ministerial Ordinance, GMP Ministerial Ordinance on Drugs and Quasi-drugs, GMS Ministerial Ordinance on Medical Devices and In Vitro Diagnostics, and Regulations for Buildings and Facilities<\/td>
-<\/div><\/td>
Listed in the CD<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n\n

<\/a><\/p>\n

\u3010\uff2d\uff26\u95a2\u4fc2\uff0fMF\u3011<\/h3>\n\n\n\n\n\t\n\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t\n\t
\u65e5\u4ed8\/
\n\u767a\u51fa\u756a\u53f7<\/th>		\u901a\u77e5\u7b49\u4ef6\u540d<\/th>\u901a\u77e5\u5185\u5bb9<\/th>\u901a\u77e5URL<\/th>\n<\/tr>\n<\/thead>\n
Dated\/
\nNotification No.<\/sapn><\/td>		Title<\/td>Contents<\/td>URL of notification<\/td>\n<\/tr>\n
-<\/div><\/td>
\u539f\u85ac\u7b49\u767b\u9332\u5236\u5ea6\u306e\u6982\u8981\u306b\u3064\u3044\u3066<\/td>\u767b\u9332\u7533\u8acb\u306b\u95a2\u3059\u308b\u89e3\u8aac<\/td>CD\u306b\u53ce\u8f09<\/td>\n<\/tr>\n
-<\/div><\/td>
Master File System for Drug Substances, etc.<\/td>Comments on register application<\/td>Listed in the CD<\/td>\n<\/tr>\n
\u69d8\u5f0f
\nForms<\/td>		\u5225\u7d191\u3000\u539f\u85ac\u7b49\u767b\u9332\u539f\u7c3f\u767b\u9332\u7533\u8acb\u66f8\uff08\u69d8\u5f0f42\uff09
\nApplication for Registration of the Drug Master File\uff08Form No. 42 (in relation to Article 72)\uff09<\/td>		CD\u306b\u53ce\u8f09
\nListed in the CD<\/td>\n<\/tr>\n
\u5225\u7d192\u3000\u539f\u85ac\u7b49\u767b\u9332\u539f\u7c3f\u5909\u66f4\u767b\u9332\u7533\u8acb\u66f8\uff08\u69d8\u5f0f46\uff09
\nApplication for Registration of Amendment to Particulars Registered in Drug Master File\uff08 Form No. 46\uff08in relation to Article 79\uff09\uff09<\/td>		CD\u306b\u53ce\u8f09
\nListed in the CD<\/td>\n<\/tr>\n
\u5225\u7d193\u3000\u539f\u85ac\u7b49\u767b\u9332\u539f\u7c3f\u8efd\u5fae\u5909\u66f4\u5c4a\u66f8\uff08\u69d8\u5f0f47\uff09
\nReport of Minor Modification to Particulars Registered to the Drug Master File\uff08Form No. 47 (in relation to Article 81)\uff09<\/td>		CD\u306b\u53ce\u8f09
\nListed in the CD<\/td>\n<\/tr>\n
\u5ba3\u8a93\u66f8
\nStatement<\/td>		CD\u306b\u53ce\u8f09
\nListed in the CD<\/td>\n<\/tr>\n
\u5e73\u621017.02.10
\n
\n\u85ac\u98df\u5be9\u67fb\u767a\u7b2c0210004\u53f7<\/td>		\u539f\u85ac\u7b49\u767b\u9332\u539f\u7c3f\u306e\u5229\u7528\u306b\u95a2\u3059\u308b\u6307\u91dd\u306b\u3064\u3044\u3066<\/td>MF\u3092\u5229\u7528\u3057\u305f\u627f\u8a8d\u66f8\u306e\u88fd\u9020\u65b9\u6cd5\u306e\u8a18\u8f09\u65b9\u6cd5<\/td>CD\u306b\u53ce\u8f09<\/td>\n<\/tr>\n
February 10,2005
\n
\nPFSB\/ELD
\nNotification
\nNo.0210004
\n(Revised in accordance with
\nPFSB\/ELD Notification
\nNo.0619004
\nJune 19,2007) <\/td>		Guideline on Utilization of Master File for Drug Substances, etc.<\/td>Descriptive guidelines to production method on certificate of approval utilized Drug Master File<\/td>Listed in the CD<\/td>\n<\/tr>\n
\u5e73\u621017.07.28
\n
\n\u539a\u751f\u52b4\u50cd\u7701\u533b\u85ac\u98df\u54c1\u5c40
\n\u5be9\u67fb\u7ba1\u7406\u8ab2\uff08\u4e8b\u52d9\u9023\u7d61\uff09<\/td>		\u539f\u85ac\u7b49\u767b\u9332\u539f\u7c3f\u306b\u95a2\u3059\u308b\u8cea\u7591\u5fdc\u7b54\uff08Q\uff06A\uff09\u306b\u3064\u3044\u3066<\/td>
-<\/div><\/td>
CD\u306b\u53ce\u8f09<\/td>\n<\/tr>\n
July 28,2005
\n
\nOffice Memorandum<\/td>		Q&A on the Master File (MF)
\nSystem, Part I <\/td>
-<\/div><\/td>
Listed in the CD<\/td>\n<\/tr>\n
\u5e73\u621017.12.20
\n
\n\u539a\u751f\u52b4\u50cd\u7701\u533b\u85ac\u98df\u54c1\u5c40
\n\u5be9\u67fb\u7ba1\u7406\u8ab2\uff08\u4e8b\u52d9\u9023\u7d61\uff09<\/td>		\u539f\u85ac\u7b49\u767b\u9332\u539f\u7c3f\u306b\u95a2\u3059\u308b\u8cea\u7591\u5fdc\u7b54\uff08Q\uff06A\uff09\u306b\u3064\u3044\u3066
\n\uff08\u305d\u306e2\uff09<\/td>
-<\/div><\/td>
CD\u306b\u53ce\u8f09<\/td>\n<\/tr>\n
December 20,2005
\n
\nOffice Memorandum<\/td>		Q&A on the Master File (MF)
\nSystem, Part II<\/td>
-<\/div><\/td>
Listed in the CD<\/td>\n<\/tr>\n
\u5e73\u621018.2.8
\n
\n\u85ac\u98df\u5be9\u67fb\u767a\u7b2c0208001\u53f7<\/td>		\u539f\u85ac\u7b49\u767b\u9332\u539f\u7c3f\u306b\u767b\u9332\u3055\u308c\u305f\u54c1\u76ee\u306e\u6574\u7406\u306b\u3064\u3044\u3066<\/td>
-<\/div><\/td>
CD\u306b\u53ce\u8f09<\/td>\n<\/tr>\n
February 8,2006
\n
\nPFSB \/ ELD Notification No.0208001<\/td>		Cancellation of items registered in Drug Master Files<\/td>
-<\/div><\/td>
Listed in the CD<\/td>\n<\/tr>\n
\u69d8\u5f0f
\nForms<\/td>		\u5225\u7d19\u69d8\u5f0f\u3000\u767b\u9332\u6574\u7406\u5c4a\u66f8
\nAttached Form\u3000Notification of MF Registration Cancellation<\/td>		CD\u306b\u53ce\u8f09
\nListed in the CD<\/td>\n<\/tr>\n
\u5ba3\u8a93\u66f8
\nStatement<\/td>		CD\u306b\u53ce\u8f09
\nListed in the CD<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n\n

<\/a><\/p>\n

\u3010\u65e5\u5c40\u95a2\u4fc2\uff0fPHARMACOPEIA\u3011<\/h3>\n\n\n\n\n\t\n\n\t\n\t\n\t\n\t\n\t
\u65e5\u4ed8\/
\n\u767a\u51fa\u756a\u53f7<\/th>		\u901a\u77e5\u7b49\u4ef6\u540d<\/th>\u901a\u77e5\u5185\u5bb9<\/th>\u901a\u77e5URL<\/th>\n<\/tr>\n<\/thead>\n
Dated\/
\nNotification No.<\/sapn><\/td>		Title<\/td>Contents<\/td>URL of notification<\/td>\n<\/tr>\n
\u5e73\u621023.3.24
\n
\n\u539a\u751f\u52b4\u50cd\u7701\u544a\u793a\u7b2c65\u53f7<\/td>		\u7b2c\u5341\u516d\u6539\u6b63\u65e5\u672c\u85ac\u5c40\u65b9<\/td>
-<\/div><\/td>
CD\u306b\u53ce\u8f09<\/td>\n<\/tr>\n
March 24,2011
\n
\nMinistry of Health, Labour and Welfare Notification No.65<\/td>		The Japanese Pharmacopoeia,Sixteenth Edition<\/td>
-<\/div><\/td>
Listed in the CD
\n<\/td>\n<\/tr>\n
\u5e73\u621024.9.27
\n
\n\u539a\u751f\u52b4\u50cd\u7701\u544a\u793a\u7b2c519\u53f7<\/td>		\u7b2c\u5341\u516d\u6539\u6b63\u65e5\u672c\u85ac\u5c40\u7b2c\u4e00\u8ffd\u88dc<\/td>
-<\/div><\/td>
CD\u306b\u53ce\u8f09<\/td>\n<\/tr>\n
September 27,2012
\n
\nMinistry of Health, Labour and Welfare Notification No.519<\/td>		The 16th Edition,supplement I<\/td>
-<\/div><\/td>
Listed in the CD<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n\n","protected":false},"excerpt":{"rendered":"

Laws, Ordinances and Administrative Notices relating to API manufacturers overseas \u3000\u5f53\u5354\u4f1a\u306b\u304a\u3044\u3066\u3001\u539f\u85ac\u7b49\u306e\u5916\u56fd\u88fd\u9020\u696d\u8005\u304c\u65e5\u672c\u306e\u85ac\u4e8b\u5236\u5ea6\u3092\u7406\u89e3\u3059\u308b\u305f\u3081\u306b\u5fc5\u8981\u3068\u306a\u308b\u95a2\u4fc2\u6cd5\u4ee4\u53ca\u3073\u901a\u77e5\u7b49\u306e\u82f1\u8a33\u30ea\u30b9\u30c8\uff08\u65e5\u672c\u8a9e\u30fb\u82f1\u8a9e\u4f75\u8a18\uff09\u3092\u4f5c\u6210\u3044\u305f\u3057\u307e\u3057\u305f\u3002 \u3053\u306e\u30ea\u30b9\u30c8\u306b\u3088\u308a\u3001\u65e5\u672c\u306b\u304a\u3044\u3066\u82f1\u8a33\u304c\u884c\u308f\u308c\u3066\u3044\u308b\u85ac\u4e8b\u6cd5\u3001\u540c\u653f\u7701\u4ee4\u3001\u539f\u85ac\u95a2\u4fc2\u901a\u77e5\u53ca\u3073\u89e3\u8aac\u6587\u7b49\u306e\u82f1\u8a33\u5143\u3092\u3054\u7d39\u4ecb\u3059\u308b\u3068\u5171\u306b\u3001\u305d\u308c\u3089\u304c\u516c\u8868\u3055\u308c\u3066\u3044\u308b\u30db\u30fc\u30e0\u30da\u30fc\u30b8\u53c8\u306f\u5f53\u5354\u4f1a\u3067\u72ec\u81ea\u306b\u82f1\u8a33\u3057\u305f\u901a\u77e5\u7b49\u3092\u4e00\u62ec\u95b2\u89a7\u3067\u304d\u308b\u3088\u3046\u3054\u6848\u5185\u3057\u3066\u304a\u308a\u307e\u3059\u3002(\u4e00\u90e8\u4e2d\u56fd\u8a9e) \u539f\u85ac\u95a2\u4fc2\u901a\u77e5\u53ca\u3073\u89e3\u8aac\u306e\u3046\u3061\u5f53\u5354\u4f1a\u3067\u82f1\u8a33\u3057\u305f\u3082\u306e\u306f\u73fe\u5728\u4f1a\u54e1\u4ee5\u5916\u306e\u65b9\u306b\u306f\u975e\u516c\u958b\u3068\u3057\u3066\u3001\u4f1a\u54e1\u5c02\u7528\u30da\u30fc\u30b8\u306b\u63b2\u8f09\u3057\u3066\u304a\u308a\u307e\u3059\u304c\u3001\u5f53\u5354\u4f1a\u4e8b\u52d9\u5c40\u306b\u304a\u554f\u3044\u5408\u308f\u305b\u3044\u305f\u3060\u3051\u308c\u3070\u3001CD\u7248\u3092\u9812\u5e03\u3057\u3066\u304a\u308a\u307e\u3059\u306e\u3067\u3001\u305c\u3072\u3054\u6d3b\u7528\u304f\u3060\u3055\u3044\u3002 Our association provides a list of regulations and laws for better understandings of the system with foreign API manufacturers. The list indicates English translations available in Japan as well as organizations which conducted the translation. The CD-ROM with the these information is […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_locale":"en_US","_original_post":"http:\/\/182.93.127.85\/site\/?page_id=56","footnotes":""},"class_list":["post-10297","page","type-page","status-publish","hentry","en-US"],"_links":{"self":[{"href":"https:\/\/www.japta.or.jp\/wp-json\/wp\/v2\/pages\/10297","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.japta.or.jp\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.japta.or.jp\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.japta.or.jp\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.japta.or.jp\/wp-json\/wp\/v2\/comments?post=10297"}],"version-history":[{"count":13,"href":"https:\/\/www.japta.or.jp\/wp-json\/wp\/v2\/pages\/10297\/revisions"}],"predecessor-version":[{"id":10672,"href":"https:\/\/www.japta.or.jp\/wp-json\/wp\/v2\/pages\/10297\/revisions\/10672"}],"wp:attachment":[{"href":"https:\/\/www.japta.or.jp\/wp-json\/wp\/v2\/media?parent=10297"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}