{"id":3340,"date":"2022-04-13T08:34:21","date_gmt":"2022-04-13T00:34:21","guid":{"rendered":"https:\/\/regask.com\/?p=3340"},"modified":"2024-10-29T02:42:53","modified_gmt":"2024-10-28T18:42:53","slug":"%e3%83%95%e3%82%a3%e3%83%aa%e3%83%94%e3%83%b3-fda-one-asean-%e8%a6%8f%e5%88%b6","status":"publish","type":"post","link":"https:\/\/regask.com\/ja\/philippines-fda-one-asean-regulation\/","title":{"rendered":"\u30d5\u30a3\u30ea\u30d4\u30f3 FDA \u306f\u3001\u2026 \u306e\u5f37\u5236\u5b9f\u65bd\u3092\u518d\u78ba\u8a8d\u3057\u307e\u3059"},"content":{"rendered":"<div><a href=\"https:\/\/www.fda.gov.ph\/\" target=\"_blank\" rel=\"noopener\">FDA\u30d5\u30a3\u30ea\u30d4\u30f3<\/a> \u5316\u7ca7\u54c1\u5c4a\u51fa\u3084\u5316\u7ca7\u54c1\u88fd\u54c1\u60c5\u5831\u30d5\u30a1\u30a4\u30eb\uff08PIF\uff09\u306a\u3069\u3001ASEAN\u5316\u7ca7\u54c1\u6307\u4ee4\u306e\u5e02\u8ca9\u524d\u304a\u3088\u3073\u5e02\u8ca9\u5f8c\u306e\u898f\u5236\u30d7\u30ed\u30bb\u30b9\u306b\u95a2\u3059\u308b\u60c5\u5831\u3092\u63d0\u4f9b\u3057\u307e\u3059\u3002<\/div>\n<div><\/div>\n<div>PIF \u306f\u3001\u5316\u7ca7\u54c1\u306e\u6280\u8853\u60c5\u5831\u3068\u5b89\u5168\u6027\u306b\u95a2\u3059\u308b\u60c5\u5831\u304c\u8a18\u8f09\u3055\u308c\u305f\u6587\u66f8\u3067\u3059\u3002CF No. 2018-001 \u3067\u306f\u3001\u4ee5\u4e0b\u306b\u793a\u3059\u3088\u3046\u306b\u3001PIF \u306b\u542b\u3081\u308b\u5fc5\u8981\u304c\u3042\u308b\u6587\u66f8\u306e\u30ea\u30b9\u30c8\u304c\u6307\u5b9a\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/div>\n<div><\/div>\n<ul>\n<li>\u30d1\u30fc\u30c8 I: \u7ba1\u7406\u6587\u66f8\u3068\u88fd\u54c1\u6982\u8981<\/li>\n<li>\u30d1\u30fc\u30c8II\uff1a\u539f\u6750\u6599\u306e\u54c1\u8cea\u30c7\u30fc\u30bf<\/li>\n<li>\u30d1\u30fc\u30c8III: \u5b8c\u6210\u54c1\u306e\u54c1\u8cea\u30c7\u30fc\u30bf<\/li>\n<li>\u30d1\u30fc\u30c8IV: \u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u306b\u95a2\u3059\u308b\u30c7\u30fc\u30bf<\/li>\n<\/ul>\n<p>\u3055\u3089\u306b\u3001FDA \u306f\u3001\u8ca9\u58f2\u627f\u8a8d\u4fdd\u6709\u8005 (MAH) \u306e\u4ee5\u4e0b\u306e\u8cac\u4efb\u3092\u7e70\u308a\u8fd4\u3057\u8ff0\u3079\u3066\u3044\u307e\u3059\u3002<\/p>\n<ol>\n<li>FDA\u306b\u5316\u7ca7\u54c1\u3092\u901a\u77e5\u3057\u305fMAH\u307e\u305f\u306f\u300c\u88fd\u54c1\u3092\u5e02\u5834\u306b\u51fa\u3059\u8cac\u4efb\u3092\u8ca0\u3046\u4f1a\u793e\u300d\u306f\u3001\u6700\u65b0\u306ePIF\u3092\u4fdd\u7ba1\u304a\u3088\u3073\u7dad\u6301\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002<\/li>\n<li>FDA\u306b\u901a\u77e5\u3055\u308c\u305f\u3059\u3079\u3066\u306e\u5316\u7ca7\u54c1\u95a2\u7a0e\u306b\u306f\u3001\u5bfe\u5fdc\u3059\u308bPIF\u304c\u5fc5\u8981\u3067\u3059\u3002<\/li>\n<li>MAH\u306fCF No. 2018-001\u306b\u898f\u5b9a\u3055\u308c\u3066\u3044\u308bPIF\u30d5\u30a9\u30fc\u30de\u30c3\u30c8\u306b\u5f93\u3046\u3082\u306e\u3068\u3059\u308b\u3002<\/li>\n<\/ol>\n<div>\n<div>\n<div><a href=\"https:\/\/regask.com\/ja\/%e6%8e%a5%e8%a7%a6\/\">\u30d5\u30a3\u30ea\u30d4\u30f3\u306e\u5316\u7ca7\u54c1\u898f\u5236\u306e\u5909\u66f4\u306b\u5099\u3048\u3066RegASK\u306b\u304a\u554f\u3044\u5408\u308f\u305b\u304f\u3060\u3055\u3044<\/a><span style=\"color: #555555;\">.<\/span><\/div>\n<div><\/div>\n<div><\/div>\n<\/div>\n<\/div>\n<a href=\"https:\/\/regask.com\/ja\/%e6%8e%a5%e8%a7%a6\/\" class=\"button secondary\" style=\"border-radius:10px;\">\n\t\t<span>\u8a73\u7d30\u306b\u3064\u3044\u3066\u306fRegASK\u306b\u304a\u554f\u3044\u5408\u308f\u305b\u304f\u3060\u3055\u3044<\/span>\n\t<\/a>\n\n<a href=\"https:\/\/www.fda.gov.ph\/wp-content\/uploads\/2022\/03\/FDA-Advisory-No.2022-0383.pdf\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>\u7d9a\u304d\u3092\u8aad\u3080<\/span>\n\t<\/a>\n\n<div class=\"row\"  id=\"row-622463477\">\n\n\t<div id=\"col-496441202\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<a href=\"https:\/\/regask.com\/ja\/%e3%82%b1%e3%83%bc%e3%82%b9%e3%82%b9%e3%82%bf%e3%83%87%e3%82%a3-2\/%e3%83%aa%e3%82%bd%e3%83%bc%e3%82%b9-%e3%82%b1%e3%83%bc%e3%82%b9%e3%82%b9%e3%82%bf%e3%83%87%e3%82%a3-%e3%83%91%e3%83%bc%e3%82%bd%e3%83%8a%e3%83%ab%e3%82%b1%e3%82%a2-%e5%8c%96%e7%b2%a7%e5%93%81\/\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>\u30d1\u30fc\u30bd\u30ca\u30eb\u30b1\u30a2\u3068\u5316\u7ca7\u54c1\u696d\u754c\u306e\u30b1\u30fc\u30b9\u30b9\u30bf\u30c7\u30a3\u3092\u8aad\u3080<\/span>\n\t<\/a>\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n<\/div>","protected":false},"excerpt":{"rendered":"<p>The FDA Philippines provides information on the ASEAN Cosmetic Directive&#8217;s pre-and post-marketing regulatory processes, such as Cosmetic Notification and the Cosmetic Product Information File (PIF), among others. The PIF is a document containing the technical and safety information of the cosmetic product. CF No. 2018-001 specifies the list of documents that must be part of the PIF, as shown below: Part I: Administrative Documents and Product Summary Part II: Quality Data of Raw Material Part III: Quality Data of Finished Product Part IV: Safety and Efficacy Data Moreover, the FDA reiterates the following responsibilities of the Marketing Authorisation Holder (MAH): The MAH or the &#8220;Company Responsible for Placing the Product&#8230;<\/p>","protected":false},"author":39,"featured_media":2933,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[588,37],"tags":[40],"class_list":["post-3340","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-philippines-regulations","category-personal-care-cosmetics","tag-latest-insights"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.3 (Yoast SEO v27.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Philippines FDA: One ASEAN Regulation Mandatory | RegASK<\/title>\n<meta name=\"description\" content=\"The Philippines FDA reiterates the mandatory implementation of the One ASEAN Regulation. 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