{"id":958,"date":"2024-03-06T16:16:16","date_gmt":"2024-03-06T08:16:16","guid":{"rendered":"https:\/\/consulting-hmk.com\/?p=958"},"modified":"2024-03-06T16:22:32","modified_gmt":"2024-03-06T08:22:32","slug":"nmpa-will-implement-the-key-points-of-the-complete-version-of-the-safety-assessment-report-from-may-1","status":"publish","type":"post","link":"https:\/\/www.consulting-hmk.com\/ja\/nmpa-will-implement-the-key-points-of-the-complete-version-of-the-safety-assessment-report-from-may-1\/","title":{"rendered":"NMPA\u306f5\u67081\u65e5\u3088\u308a\u5b89\u5168\u6027\u8a55\u4fa1\u5831\u544a\u66f8\u5b8c\u5168\u7248\u306e\u30dd\u30a4\u30f3\u30c8\u3092\u5b9f\u65bd\u3059\u308b\u3002"},"content":{"rendered":"

\u00a0 \u00a0 \u00a0 \u5316\u7ca7\u54c1\u5b89\u5168\u6027\u8a55\u4fa1\u6280\u8853\u6307\u91dd\uff082021\u5e74\u7248\uff09\u300d\u306e\u30dd\u30a4\u30f3\u30c87\u300c\u5316\u7ca7\u54c1\u306e\u5b89\u5168\u6027\u8a55\u4fa1\u300d\u306b\u3088\u308b\u3068\u3001\u7c21\u6613\u7248\u5b89\u5168\u6027\u8a55\u4fa1\u306b\u6bd4\u3079\u3001\u5b8c\u5168\u7248\u5b89\u5168\u6027\u8a55\u4fa1\u3067\u306f2\u3064\u306e\u8a55\u4fa1\u4e8b\u696d\u8981\u4ef6\u304c\u8ffd\u52a0\u3055\u308c\u3066\u3044\u308b\u3053\u3068\u304c\u308f\u304b\u308b\u3002\u5177\u4f53\u7684\u306a\u8a55\u4fa1\u9805\u76ee\u306f\u4ee5\u4e0b\u306e\u901a\u308a\u3067\u3059\u3002<\/span><\/p>\n

1.\u88fd\u54c1\u306e\u7269\u7406\u7684\u30fb\u5316\u5b66\u7684\u5b89\u5b9a\u6027\u8a55\u4fa1<\/span><\/strong><\/h2>\n

\u00a0 \u00a0 1.1 \u88fd\u54c1\u306e\u5b89\u5b9a\u6027\u3092\u5224\u65ad\u3057\u3001\u5e02\u5834\u306b\u51fa\u56de\u308b\u5316\u7ca7\u54c1\u306e\u5404\u30d0\u30c3\u30c1\u306e\u5b89\u5b9a\u3057\u305f\u54c1\u8cea\u3092\u4fdd\u8a3c\u3059\u308b\u305f\u3081\u306b\u3001 \u95a2\u9023\u3059\u308b\u7269\u7406\u7684\u304a\u3088\u3073\u5316\u5b66\u7684\u6307\u6a19\u306f\u3001\u88fd\u54c1\u306e\u7279\u5b9a\u306e\u6761\u4ef6\u306b\u57fa\u3065\u3044\u3066\u8a55\u4fa1\u3055\u308c\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002\u4e00\u822c\u7684\u306b\u3001\u4ee5\u4e0b\u306e\u30d1\u30e9\u30e1\u30fc\u30bf\u304c\u542b\u307e\u308c\u308b\uff1a<\/span><\/p>\n

(1) \u7269\u7406\u7684\u306a\u72b6\u614b\uff1b<\/span><\/p>\n

(2) \u5264\u5f62\uff08\u4e73\u5264\u3001\u7c89\u672b\u306a\u3069\uff09\uff1b<\/span><\/p>\n

(3) \u5b98\u80fd\u7684\u7279\u5fb4\uff08\u8272\u3001\u5302\u3044\u306a\u3069\uff09\uff1b<\/span><\/p>\n

(4) pH\u5024\uff08\u3069\u306e\u3088\u3046\u306a\u6e29\u5ea6\u6761\u4ef6\u4e0b\u3067\uff09\uff1b<\/span><\/p>\n

(5) \u7c98\u5ea6\uff08\u3069\u306e\u3088\u3046\u306a\u6e29\u5ea6\u6761\u4ef6\u4e0b\u3067\uff09\uff1b<\/span><\/p>\n

(6)\u7279\u5b9a\u306e\u30cb\u30fc\u30ba\u306b\u5fdc\u3058\u305f\u305d\u306e\u4ed6\u306e\u5074\u9762\u3002<\/span><\/p>\n

\u00a0 \u00a0 1.2 \u539f\u6599\u9593\u306e\u5316\u5b66\u7684\u53ca\u3073\uff0f\u53c8\u306f\u751f\u7269\u5b66\u7684\u76f8\u4e92\u4f5c\u7528\u306e\u6709\u7121\u3092\u78ba\u8a8d\u3057\u3001\u76f8\u4e92\u4f5c\u7528\u304b\u3089\u751f\u3058\u308b\u6f5c\u5728\u7684\u306a\u5b89\u5168\u6027\u30ea\u30b9\u30af\u3092\u691c\u8a0e\u3059\u308b\u3002\u6f5c\u5728\u7684\u306a\u5b89\u5168\u6027\u30ea\u30b9\u30af\u304c\u3042\u308b\u5834\u5408\u306f\u3001\u95a2\u9023\u3059\u308b\u6587\u732e\u7814\u7a76\u30c7\u30fc\u30bf\u307e\u305f\u306f\u7269\u7406\u7684\u30fb\u5316\u5b66\u7684\u5b9f\u9a13\u30c7\u30fc\u30bf\u3068\u4f75\u305b\u3066\u30a2\u30bb\u30b9\u30e1\u30f3\u30c8\u3092\u5b9f\u65bd\u3059\u308b\u3053\u3068\u3002<\/span><\/p>\n

\u00a0 \u00a0 1.3 \u5185\u5bb9\u7269\u3068\u76f4\u63a5\u63a5\u89e6\u3059\u308b\u5bb9\u5668\u53c8\u306f\u62c5\u4f53\u306e\u7269\u7406\u7684\u30fb\u5316\u5b66\u7684\u5b89\u5b9a\u6027\u53ca\u3073\u88fd\u54c1\u3068\u306e\u9069\u5408\u6027\u3092\u8a55\u4fa1\u3059\u308b\u3002\u5bb9\u5668\u306e\u5b89\u5b9a\u6027\u306f\u3001\u5305\u88c5\u6750\u53c8\u306f\u62c5\u4f53\u306e\u4f9b\u7d66\u8005\u306e\u5b89\u5168\u6027\u60c5\u5831\u53c8\u306f\u5b89\u5168\u30b9\u30c6\u30fc\u30c8\u30e1\u30f3\u30c8\u3092\u53c2\u7167\u3059\u308b\u3053\u3068 \u306b\u3088\u308a\u8a55\u4fa1\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u3002<\/span><\/p>\n

\u00a0 \u00a0 1.4 \u51e6\u65b9\u4f53\u7cfb\u304c\u985e\u4f3c\u3057\u3001\u5305\u88c5\u6750\u6599\u304c\u540c\u3058\u5316\u7ca7\u54c1\u306b\u3064\u3044\u3066\u306f\u3001\u65e2\u5b58\u306e\u60c5\u5831\u3084\u5b9f\u9a13\u30c7\u30fc\u30bf\u306b\u57fa\u3065\u3044\u3066\u7269\u7406\u7684\u30fb\u5316\u5b66\u7684\u5b89\u5b9a\u6027\u3092\u8a55\u4fa1\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u304c\u3001\u305d\u306e\u7406\u7531\u3092\u8aac\u660e\u3057\u3001\u72b6\u6cc1\u3092\u8aac\u660e\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002<\/span><\/p>\n

\u00a0 \u00a0 1.5 \u6750\u6599\u306e\u5b89\u5b9a\u6027\u3068\u5305\u88c5\u6750\u6599\u306e\u9069\u5408\u6027\u3092\u7406\u89e3\u3059\u308b\u65b9\u6cd5<\/span><\/p>\n

\u00a0 \u00a0 1.5.1 \u5b89\u5b9a\u6027\u8a66\u9a13\uff1a\u9069\u5207\u306a\u6761\u4ef6\u4e0b\u3067\u6d88\u8cbb\u8005\u304c\u4fdd\u7ba1\u3057\u4f7f\u7528\u3057\u305f\u5834\u5408\u306b\u3001\u88fd\u54c1\u304c\u671b\u307e\u3057\u3044\u7269\u7406\u7684\u3001\u5316\u5b66 \u7684\u3001\u5fae\u751f\u7269\u5b66\u7684\u7279\u6027\u4e26\u3073\u306b\u6a5f\u80fd\u7684\u53ca\u3073\u5b98\u80fd\u7684\u7279\u6027\u3092\u7dad\u6301\u3059\u308b\u80fd\u529b\u3092\u8a55\u4fa1\u3059\u308b\u305f\u3081\u306b\u8a2d\u8a08\u3055 \u308c\u305f\u8a66\u9a13\u3002<\/span><\/p>\n

\u00a0 \u00a0 \u3088\u308a\u7c21\u5358\u306b\u8a00\u3048\u3070\u3001\u5b89\u5b9a\u6027\u8a66\u9a13\u306e\u76ee\u7684\u306f\u3001\u88fd\u54c1\u306e\u8cde\u5473\u671f\u9650\u3092\u6c7a\u5b9a\u3057\u3001\u30d1\u30c3\u30b1\u30fc\u30b8\u5185\u306e\u88fd\u54c1\u304c\u8ca9\u58f2\u30fb\u4f7f\u7528\u3055\u308c\u308b\u5e02\u5834\u6761\u4ef6\u4e0b\u3067\u5b89\u5b9a\u3057\u3066\u3044\u308b\u304b\u3069\u3046\u304b\u3092\u8a55\u4fa1\u3059\u308b\u3053\u3068\u3067\u3042\u308b\u3002\u300c\u5e02\u5834\u6761\u4ef6\u300d\u306b\u306f\u3001\u6d41\u901a\uff08\u8f38\u9001\uff09\u3001\u5009\u5eab\u4fdd\u7ba1\u3001\u4f7f\u7528\u6642\u306e\u6761\u4ef6\u304c\u542b\u307e\u308c\u308b\u3002\u3057\u305f\u304c\u3063\u3066\u3001\u5b89\u5b9a\u6027\u8a66\u9a13\u306f\u88fd\u54c1\u306e\u54c1\u8cea\u3092\u4fdd\u8a3c\u3059\u308b\u305f\u3081\u306e\u524d\u63d0\u6761\u4ef6\u3068\u8003\u3048\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u3002\u5316\u7ca7\u54c1\u306f\u5b89\u5b9a\u6027\u8a66\u9a13\u3092\u53d7\u3051\u308b\u5fc5\u8981\u304c\u3042\u308b\u3002<\/span><\/p>\n

\u00a0 \u00a0 1.5.2 \u5305\u88c5\u6750\u6599\u306e\u9069\u5408\u6027\uff1a<\/span><\/p>\n

\u00a0 \u00a0 1.6 \u5b89\u5b9a\u6027\u3068\u4e92\u63db\u6027\u306e\u57fa\u6e96\u898f\u683c<\/span><\/p>\n

\u00a0 \u00a0 1.6.1 \u53c2\u7167\u53ef\u80fd\u306a\u95a2\u9023\u5916\u56fd\u898f\u683c\uff1a<\/span><\/p>\n

(1) \u56fd\u969b\u6a19\u6e96\u5316\u6a5f\u69cb ISO\/TR 18811-2018 \u300c\u5316\u7ca7\u54c1-\u5316\u7ca7\u54c1\u306e\u5b89\u5b9a\u6027\u8a66\u9a13\u306b\u95a2\u3059\u308b\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3<\/span><\/p>\n

(2) CTFA\/Colipa\u300c\u5316\u7ca7\u54c1\u306e\u5b89\u5b9a\u6027\u8a66\u9a13\u306b\u95a2\u3059\u308b\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3<\/span><\/p>\n

(3) PCPC\u300c\u696d\u754c\u5411\u3051\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3-\u5316\u7ca7\u54c1\u306e\u5b89\u5b9a\u6027\u8a66\u9a13<\/span><\/p>\n

\u00a0 \u00a0 1.6.2 \u53c2\u7167\u53ef\u80fd\u306a\u95a2\u9023\u56fd\u5185\u898f\u683c<\/span><\/p>\n

(1) T\/SHFCA 002-2021 \"\u5316\u7ca7\u54c1\u306e\u5b89\u5b9a\u6027\u8a66\u9a13\u306e\u6307\u91dd\"<\/span><\/p>\n

(2) T\/GDCQMA 002-2023 \"\u5316\u7ca7\u54c1\u5b89\u5b9a\u6027\u8a66\u9a13\u4ed5\u69d8\u66f8\"<\/span><\/p>\n

2.\u88fd\u54c1\u306e\u5fae\u751f\u7269\u5b66\u7684\u8a55\u4fa1<\/span><\/strong><\/span><\/h2>\n

\u00a0 \u00a0 2.1 \u5316\u7ca7\u54c1\u306e\u5fae\u751f\u7269\u6c5a\u67d3\u306f\u901a\u5e38\u3001\u539f\u6599\u306e\u6301\u3061\u8fbc\u307f\u3001\u88fd\u54c1\u306e\u8abf\u88fd\u30fb\u5145\u586b\u5de5\u7a0b\u3001\u6d88\u8cbb\u8005\u306e\u4f7f\u7528\u304b\u3089\u751f\u3058\u308b\u3002\u5b50\u4f9b\u7528\u5316\u7ca7\u54c1\u3068\u76ee\u5143\u30fb\u53e3\u5143\u7528\u5316\u7ca7\u54c1\u306f\u3001\u5fae\u751f\u7269\u6c5a\u67d3\u306b\u7279\u306b\u6ce8\u610f\u3059\u3079\u304d\u3067\u3042\u308b\u3002<\/span><\/p>\n

\u00a0 \u00a0 2.2 \u7814\u7a76\u958b\u767a\u6bb5\u968e\u306e\u5316\u7ca7\u54c1\u306b\u3064\u3044\u3066\u306f\u3001\u56fd\u969b\u7684\u306b\u8a8d\u3081\u3089\u308c\u305f\u57fa\u6e96\u307e\u305f\u306f\u65b9\u6cd5\u3092\u53c2\u8003\u306b\u3001\u9632\u8150\u5264\u30b7\u30b9\u30c6\u30e0\u306e\u6709\u52b9\u6027\u3092\u8a55\u4fa1\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u3002<\/span><\/p>\n

\u00a0 \u00a0 2.3 \u540c\u3058\u9632\u9306\u30b7\u30b9\u30c6\u30e0\u304a\u3088\u3073\u985e\u4f3c\u51e6\u65b9\u306e\u88fd\u54c1\u306b\u3064\u3044\u3066\u306f\u3001\u88fd\u54c1\u306e\u5b89\u5168\u6027\u8a55\u4fa1\u306e\u305f\u3081\u306b\u65e2\u5b58\u306e\u60c5\u5831\u304a\u3088\u3073\u5b9f\u9a13\u30c7\u30fc\u30bf\u3092\u53c2\u7167\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u3002\u88fd\u54c1\u7279\u6027\u306b\u3088\u308c\u3070\u3001\u5fae\u751f\u7269\u6c5a\u67d3\u306e\u5f71\u97ff\u3092\u53d7\u3051\u306b\u304f\u3044\u88fd\u54c1\u3001\u3059\u306a\u308f\u3061\u975e\u6c34\u7cfb\u88fd\u54c1\u3001\u6709\u6a5f\u6eb6\u5264\u3092\u30d9\u30fc\u30b9\u3068\u3059\u308b\u88fd\u54c1\u3001\u6c34\u5206\u6d3b\u60270.7\u672a\u6e80\u3001\u30a8\u30bf\u30ce\u30fc\u30eb\u542b\u6709\u91cf20%\uff08\u5bb9\u91cf\uff09\u4ee5\u4e0a\u3001pH\u5024\u304c\u9ad8\u3044\uff0f\u4f4e\u3044\uff08\u226710\u307e\u305f\u306f\u22663\uff09\u3001\u5145\u586b\u6e29\u5ea6\u304c65\u2103\u4ee5\u4e0a\u306e\u88fd\u54c1\u3001\u4f7f\u3044\u6368\u3066\u307e\u305f\u306f\u5305\u88c5\u3092\u958b\u5c01\u3067\u304d\u306a\u3044\u88fd\u54c1\u306a\u3069\u306e\u6c34\u7cfb\u88fd\u54c1\u3067\u3042\u308b\u3002\u3053\u308c\u3089\u306e\u88fd\u54c1\u306f\u9632\u8150\u52b9\u679c\u3092\u8a55\u4fa1\u3059\u308b\u5fc5\u8981\u306f\u306a\u3044\u304c\u3001\u5316\u7ca7\u54c1\u5b89\u5168\u6027\u8a55\u4fa1\u8005\u306f\u95a2\u9023\u3059\u308b\u72b6\u6cc1\u3092\u8aac\u660e\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u3002<\/span><\/p>\n

\u00a0 \u00a0 2.4 \u9632\u9306\u306e\u8ab2\u984c\u3092\u7406\u89e3\u3059\u308b\u65b9\u6cd5<\/span><\/p>\n

\u00a0 \u00a0 2.4.1 \u9632\u9306\u30c1\u30e3\u30ec\u30f3\u30b8\uff1a\u9632\u9306\u30c1\u30e3\u30ec\u30f3\u30b8\u8a66\u9a13\u306f\u3001\u5316\u7ca7\u54c1\u8a66\u9a13\u306b\u304a\u3044\u3066\u91cd\u8981\u306a\u9805\u76ee\u3067\u3042\u308b\u3002\u3053\u306e\u65b9\u6cd5\u306f\u3001\u5316\u7ca7\u54c1\u306b\u4ee3\u8868\u7684\u306a\u5fae\u751f\u7269\u3092\u4e00\u5b9a\u91cf\u6dfb\u52a0\u3057\u3001\u5316\u7ca7\u54c1\u306e\u88fd\u9020\u30fb\u4f7f\u7528\u6642\u306b\u8d77\u3053\u308a\u3046\u308b\u9ad8\u6fc3\u5ea6\u306e\u5fae\u751f\u7269\u6c5a\u67d3\u306e\u53ef\u80fd\u6027\u3068\u3001\u81ea\u7136\u754c\u306b\u304a\u3051\u308b\u5fae\u751f\u7269\u306e\u5897\u6b96\u306b\u6700\u9069\u306a\u6761\u4ef6\u3092\u30b7\u30df\u30e5\u30ec\u30fc\u30c8\u3059\u308b\u3082\u306e\u3067\u3042\u308b\u3002\u8a66\u6599\u3092\u4e00\u5b9a\u6642\u9593\u57f9\u990a\u3057\u305f\u5f8c\u3001\u8a66\u6599\u4e2d\u306e\u5fae\u751f\u7269\u6570\u3092\u305d\u308c\u305e\u308c\u691c\u67fb\u3057\u3001\u8a66\u6599\u4e2d\u306e\u5fae\u751f\u7269\u6570\u306e\u5909\u5316\u306b\u3088\u308a\u5316\u7ca7\u54c1\u306e\u9632\u9306\u52b9\u679c\u3092\u8a55\u4fa1\u3059\u308b\u3002<\/span><\/p>\n

\u00a0 \u00a0 2.4.2 \u9632\u9306\u30c1\u30e3\u30ec\u30f3\u30b8\u30fb\u30b9\u30bf\u30f3\u30c0\u30fc\u30c9\u30fb\u30ea\u30d5\u30a1\u30ec\u30f3\u30b9<\/span><\/p>\n

(1) \u7c73\u56fd\u85ac\u5c40\u65b9 USP 40. \u6297\u83cc\u85ac\u6709\u52b9\u6027\u8a66\u9a13\uff1b<\/span><\/p>\n

(2) \u6b27\u5dde\u85ac\u5c40\u65b9 EP 5.1.3 \u6297\u83cc\u5264\u4fdd\u5b58\u306e\u6709\u52b9\u6027\uff1b<\/span><\/p>\n

(3) \u7c73\u56fd\u30d1\u30fc\u30bd\u30ca\u30eb\u30b1\u30a2\u88fd\u54c1\u5354\u4f1a PCPC 2016.\u5fae\u751f\u7269\u5b66\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3<\/span><\/p>\n

(4) \u56fd\u969b\u6a19\u6e96\u5316\u6a5f\u69cb ISO 11930-2019 Cosmetics-Microbiology-Evaluation of antimicrobial protection of a cosmetic production\uff1b<\/span><\/p>\n

(5) T\/SHRH 017-2019 \u300c\u5316\u7ca7\u54c1\u9632\u9306\u30c1\u30e3\u30ec\u30f3\u30b8\u30c6\u30b9\u30c8\u300d\u3002<\/span><\/p>","protected":false},"excerpt":{"rendered":"

\u00a0 \u00a0 \u00a0 According to point 7 \u201csafety assessment of cosmetic products\u201d of the “Technical Guidelines for Cosmetic Safety Assessment (2021 Edition)”, we can know that compared to the simplified version of the safety assessment, the full version of the safety assessment adds 2 assessment project requirements. The specific evaluation recommendations are as follows. 1. Product Physical and Chemical Stability Evaluation \u00a0 \u00a0 1.1 Relevant physical and chemical indicators should be evaluated based on the specific conditions of the product to determine the stability of the product and ensure the stable quality of each batch of cosmetics on the market. Generally, the following parameters are included: (1) Physical state; (2) […]<\/p>","protected":false},"author":4,"featured_media":959,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[200],"tags":[548,549],"acf":[],"_links":{"self":[{"href":"https:\/\/www.consulting-hmk.com\/ja\/wp-json\/wp\/v2\/posts\/958"}],"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=958"}],"version-history":[{"count":0,"href":"https:\/\/www.consulting-hmk.com\/ja\/wp-json\/wp\/v2\/posts\/958\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.consulting-hmk.com\/ja\/wp-json\/wp\/v2\/media\/959"}],"wp:attachment":[{"href":"https:\/\/www.consulting-hmk.com\/ja\/wp-json\/wp\/v2\/media?parent=958"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.consulting-hmk.com\/ja\/wp-json\/wp\/v2\/categories?post=958"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.consulting-hmk.com\/ja\/wp-json\/wp\/v2\/tags?post=958"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}