{"id":1008,"date":"2024-04-30T09:43:38","date_gmt":"2024-04-30T01:43:38","guid":{"rendered":"https:\/\/consulting-hmk.com\/?p=1008"},"modified":"2024-04-30T09:46:53","modified_gmt":"2024-04-30T01:46:53","slug":"cosmetics-adverse-reactions-collection-and-reporting-guidelines-for-registrants-and-filers-trial","status":"publish","type":"post","link":"https:\/\/www.consulting-hmk.com\/ja\/cosmetics-adverse-reactions-collection-and-reporting-guidelines-for-registrants-and-filers-trial\/","title":{"rendered":"\u5316\u7ca7\u54c1\u526f\u4f5c\u7528\u96c6\u8a08\u30fb\u5831\u544a\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\uff08\u8a66\u884c\u7248\uff09\u00a0"},"content":{"rendered":"<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt;\">2024\u5e744\u670819\u65e5\u3001\u4e2d\u56fdADR\u76e3\u8996\u56fd\u5bb6\u30bb\u30f3\u30bf\u30fc\u306f\u3001\u300c\u4e2d\u56fdADR\u76e3\u8996\u56fd\u5bb6\u30bb\u30f3\u30bf\u30fc\uff08China National Center for ADR Monitoring\uff09\u300d\u3092\u767a\u8868\u3057\u305f\u3002 <strong>\u5316\u7ca7\u54c1\u526f\u4f5c\u7528\u96c6\u8a08\u30fb\u5831\u544a\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\uff08\u8a66\u884c\u7248\uff09<\/strong>(\u4ee5\u4e0b\u3001\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\uff09\u306b\u3088\u308a\u3001\u4e2d\u56fd\u306e\u5316\u7ca7\u54c1\u526f\u4f5c\u7528\u306e\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u3068\u8a55\u4fa1\u30b7\u30b9\u30c6\u30e0\u3092\u3055\u3089\u306b\u6539\u5584\u3059\u308b\u3002<\/span><\/p>\n<p>&nbsp;<\/p>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt;\">\u73fe\u5728\u3001\u5316\u7ca7\u54c1\u306e\u526f\u4f5c\u7528\u306b\u95a2\u3059\u308b\u898f\u5236\u306b\u306f\u3001\u4ee5\u4e0b\u306e\u3088\u3046\u306a\u3082\u306e\u304c\u3042\u308b\u304c\u3001\u3053\u308c\u3089\u306b\u9650\u5b9a\u3055\u308c\u308b\u3082\u306e\u3067\u306f\u306a\u3044\uff1a<\/span><\/p>\n<ol style=\"list-style-type: upper-alpha;\">\n<li><a href=\"https:\/\/www.gov.cn\/zhengce\/zhengceku\/2020-06\/29\/content_5522593.htm\" rel=\"nofollow noopener\" target=\"_blank\"><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt;\">2021-01-01\u65bd\u884c\u300c\u5316\u7ca7\u54c1\u76e3\u7763\u7ba1\u7406\u6761\u4f8b\u300d\uff08\u56fd\u52d9\u9662[2020]\u4ee4\u7b2c727\u53f7\uff09\uff1b<\/span><\/a><\/li>\n<li><a href=\"https:\/\/www.gov.cn\/gongbao\/content\/2021\/content_5651733.htm\" rel=\"nofollow noopener\" target=\"_blank\"><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt;\">2022-01-01\u3001\u300c\u5316\u7ca7\u54c1\u751f\u7523\u304a\u3088\u3073\u904b\u55b6\u63aa\u7f6e\u306e\u76e3\u7763\u7ba1\u7406\u300d\uff08\u5e02\u5834\u76e3\u7763\u7ba1\u7406[2021]\u4ee4\u7b2c46\u53f7\uff09\uff1b<\/span><\/a><\/li>\n<li><a href=\"https:\/\/www.gov.cn\/gongbao\/content\/2022\/content_5697989.htm\" rel=\"nofollow noopener\" target=\"_blank\"><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt;\">2022-10-01\u300c\u5316\u7ca7\u54c1\u526f\u4f5c\u7528\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u7ba1\u7406\u5f01\u6cd5\u300d\uff08\u56fd\u5bb6\u85ac\u76e3\u5c40[2022]\u7b2c16\u53f7\uff09\u304c\u65bd\u884c\u3055\u308c\u308b\uff1b<\/span><\/a><\/li>\n<li><a href=\"https:\/\/www.gov.cn\/zhengce\/zhengceku\/2022-09\/29\/content_5713581.htm\" rel=\"nofollow noopener\" target=\"_blank\"><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt;\">2022-10-01\u30aa\u30f3\u30e9\u30a4\u30f3\u64cd\u4f5c\u3001\u56fd\u5bb6\u5316\u7ca7\u54c1\u526f\u4f5c\u7528\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u30b7\u30b9\u30c6\u30e0\u306e\u65b0\u30d0\u30fc\u30b8\u30e7\u30f3\uff08\u56fd\u5bb6\u85ac\u54c1\u76e3\u7763\u7ba1\u7406\u5c40[2022]\u901a\u77e5\u7b2c44\u53f7\uff09\uff1b<\/span><\/a><\/li>\n<li><a href=\"https:\/\/www.cdr-adr.org.cn\/hzp_1\/Cosmetics_zcfg\/zcfg_zdyz_c\/202404\/t20240419_50688.html\" rel=\"nofollow noopener\" target=\"_blank\"><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt;\">2024-04-19\u516c\u958b\u3001\u5316\u7ca7\u54c1\u526f\u4f5c\u7528\u767b\u9332\u30fb\u5c4a\u51fa\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\uff08\u8a66\u884c\u7248\uff09\uff08\u533b\u85ac\u54c1\u526f\u4f5c\u7528\u88ab\u5bb3\u6551\u6e08\u30bb\u30f3\u30bf\u30fc\uff09\u3002<\/span><\/a><\/li>\n<\/ol>\n<p>&nbsp;<\/p>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt;\">\u4e2d\u56fd\u306e\u65b0\u3057\u3044\u5316\u7ca7\u54c1\u898f\u5236\u306f\u3001\u5316\u7ca7\u54c1\u96fb\u5b50\u5546\u53d6\u5f15\u306e\u8ca9\u58f2\u30c1\u30e3\u30cd\u30eb\u306e\u7279\u6027\u3092\u8003\u616e\u3057\u3001\u30aa\u30f3\u30e9\u30a4\u30f3\u3067\u8cfc\u5165\u3055\u308c\u308b\u88fd\u54c1\u306e\u5b89\u5168\u76e3\u7763\u3092\u5f37\u5316\u3059\u308b\u3053\u3068\u306b\u91cd\u70b9\u3092\u7f6e\u3044\u3066\u3044\u308b\u3002\u5316\u7ca7\u54c1\u526f\u53cd\u5fdc\u76e3\u8996\u884c\u653f\u5f01\u6cd5\u300d\u306f\u3001\u8cac\u4efb\u3042\u308b\u5316\u7ca7\u54c1\u4e8b\u696d\u4f53\u306e\u767b\u9332\u8005\u304a\u3088\u3073\u5c4a\u51fa\u8005\u306e\u526f\u53cd\u5fdc\u5831\u544a\u7fa9\u52d9\u3092\u898f\u5b9a\u3057\u3066\u3044\u308b\u307b\u304b\u3001\u7b2c21\u6761\u3067\u306f\u3001\u5316\u7ca7\u54c1EC\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0\u4e8b\u696d\u8005\u304c\u85ac\u7406\u76e3\u7763\u90e8\u9580\u306b\u5831\u544a\u3059\u308b\u65b9\u6cd5\u3068\u671f\u9650\u3082\u898f\u5b9a\u3057\u3066\u3044\u308b\u3002\u6700\u8fd1\u767a\u8868\u3055\u308c\u305f\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\uff08\u8a66\u884c\u5b9f\u65bd\u7528\uff09\u3067\u306f\u3001\u5316\u7ca7\u54c1\u767b\u9332\u8005\u304a\u3088\u3073\u5c4a\u51fa\u8005\u304c\u5316\u7ca7\u54c1\u306e\u526f\u4f5c\u7528\u3092\u53ce\u96c6\u30fb\u5831\u544a\u3059\u308b\u305f\u3081\u306e\u8981\u4ef6\u304c\u3001\u30c1\u30e3\u30cd\u30eb\u3001\u5206\u6790\u30fb\u8a55\u4fa1\u3001\u63d0\u51fa\u306e\u89b3\u70b9\u304b\u3089\u8a73\u7d30\u306b\u898f\u5b9a\u3055\u308c\u3066\u3044\u308b\u3002<\/span><\/p>\n<p>&nbsp;<\/p>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt;\">HongMaoKang\u306f\u3001\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\uff08\u8a66\u9a13\u5b9f\u65bd\u7528\uff09\u306e\u4e3b\u306a\u5185\u5bb9\u3092\u307e\u3068\u3081\u305f\u3002\u5168\u56fd\u5316\u7ca7\u54c1\u526f\u4f5c\u7528\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u30b7\u30b9\u30c6\u30e0\u3092\u901a\u3058\u3066\u63d0\u51fa\u3059\u308b\u5834\u5408\u3001\u52b9\u679c\u7684\u306a\u5831\u544a\u306e4\u3064\u306e\u8981\u7d20\u3068\u5316\u7ca7\u54c1\u526f\u4f5c\u7528\u5831\u544a\u306e\u63d0\u51fa\u3068\u4ed6\u306e\u91cd\u8981\u306a\u90e8\u5206\u306b\u6ce8\u610f\u3092\u6255\u3046\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u3088\u308a\u8a73\u7d30\u306a\u60c5\u5831\u306b\u3064\u3044\u3066\u306f\u3001\u30a6\u30a7\u30d6\u30b5\u30a4\u30c8\u306b\u30e1\u30c3\u30bb\u30fc\u30b8\u3092\u6b8b\u3059\u304b\u3001\u96fb\u5b50\u30e1\u30fc\u30eb\u3067\u304a\u554f\u3044\u5408\u308f\u305b\u304f\u3060\u3055\u3044\u3002<\/span><\/p>\n<p>&nbsp;<\/p>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt;\">\u305d\u306e\u4ed6\u3001\u5316\u7ca7\u54c1\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306b\u3064\u3044\u3066\u304a\u77e5\u308a\u306b\u306a\u308a\u305f\u3044\u3053\u3068\u304c\u3054\u3056\u3044\u307e\u3057\u305f\u3089\u3001\u304a\u6c17\u8efd\u306b\u304a\u554f\u3044\u5408\u308f\u305b\u304f\u3060\u3055\u3044\u3002\u3042\u306a\u305f\u304c\u5316\u7ca7\u54c1\u3001\u6b6f\u78e8\u304d\u7c89\u3084\u539f\u6750\u6599\u306e\u5ba3\u8a00\u3001\u88fd\u54c1\u306e\u30e9\u30d9\u30ea\u30f3\u30b0\uff08\u5305\u88c5\u3092\u542b\u3080\uff09\u3001\u52b9\u80fd\u52b9\u679c\u3001\u5e83\u544a\u3084\u5ba3\u4f1d\u306e\u30ec\u30d3\u30e5\u30fc\u3001\u533b\u85ac\u54c1\u898f\u5236\u90e8\u9580\u306e\u30ec\u30d3\u30e5\u30fc\u30b3\u30e1\u30f3\u30c8\u3001\u88fd\u54c1\u3084\u539f\u6750\u6599\u306e\u691c\u67fb\u5831\u544a\u66f8\u3001\u5b89\u5168\u6027\u8a55\u4fa1\u5831\u544a\u66f8\u3001\u52b9\u80fd\u52b9\u679c\u30d7\u30ed\u30b0\u30e9\u30e0\u306e\u8a2d\u8a08\u3068\u30d7\u30ed\u30bb\u30b9\u3092\u5b9f\u884c\u3059\u308b\u3053\u3068\u306b\u3064\u3044\u3066\u306e\u8cea\u554f\u304c\u3042\u308b\u5834\u5408\u306f\u3001\u95a2\u9023\u3059\u308b\u6280\u8853\u30b5\u30fc\u30d3\u30b9\u306b\u76f8\u8ac7\u3059\u308b\u305f\u3081\u306b\u79c1\u9054\u306b\u9023\u7d61\u3059\u308b\u3053\u3068\u3092\u6b53\u8fce\u3057\u307e\u3059\u3002<\/span><\/p>","protected":false},"excerpt":{"rendered":"<p>On April 19, 2024, the China National Center for ADR Monitoring released the Cosmetics Adverse Reactions Collection and Reporting Guidelines for Registrants and Filers (Trial)(hereinafter referred to as Guidelines), to further improve China&#8217;s monitoring and evaluation system for adverse cosmetic reactions. &nbsp; As of today, regulations related to adverse cosmetic reactions include, but are not limited to: 2021-01-01 effective, &#8220;Regulations on the Supervision and Administration of Cosmetics&#8221; (State Council [2020] Order No. 727); 2022-01-01, &#8220;supervision and management of cosmetic production and operation measures&#8221; (Market Supervision Administration [2021] Order No. 46); 2022-10-01 shall come into force, &#8220;Measures for the Administration of Adverse Reaction Monitoring of Cosmetics&#8221; (State Drug Administration [2022] No. [&hellip;]<\/p>","protected":false},"author":4,"featured_media":1009,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[200],"tags":[204,206,213,549],"acf":[],"_links":{"self":[{"href":"https:\/\/www.consulting-hmk.com\/ja\/wp-json\/wp\/v2\/posts\/1008"}],"collection":[{"href":"https:\/\/www.consulting-hmk.com\/ja\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.consulting-hmk.com\/ja\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.consulting-hmk.com\/ja\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/www.consulting-hmk.com\/ja\/wp-json\/wp\/v2\/comments?post=1008"}],"version-history":[{"count":0,"href":"https:\/\/www.consulting-hmk.com\/ja\/wp-json\/wp\/v2\/posts\/1008\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.consulting-hmk.com\/ja\/wp-json\/wp\/v2\/media\/1009"}],"wp:attachment":[{"href":"https:\/\/www.consulting-hmk.com\/ja\/wp-json\/wp\/v2\/media?parent=1008"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.consulting-hmk.com\/ja\/wp-json\/wp\/v2\/categories?post=1008"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.consulting-hmk.com\/ja\/wp-json\/wp\/v2\/tags?post=1008"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}