    ﻿{"id":605259,"date":"2025-05-09T09:24:41","date_gmt":"2025-05-09T01:24:41","guid":{"rendered":"https:\/\/beta3.law.asia\/?p=605259"},"modified":"2025-08-08T10:10:59","modified_gmt":"2025-08-08T02:10:59","slug":"healthcare-life-science-regulation-japan","status":"publish","type":"post","link":"https:\/\/beta3.law.asia\/zh-hans\/healthcare-life-science-regulation-japan\/","title":{"rendered":"\u65e5\u672c\u533b\u7597\u4e0e\u751f\u547d\u79d1\u5b66\u9886\u57df\u76d1\u7ba1\u65b0\u53d1\u5c55"},"content":{"rendered":"<p style=\"text-align: justify;\"><span style=\"color: #808080;\"><strong>\u4e3a\u63a8\u52a8\u533b\u7597\u6570\u636e\u7684\u5e94\u7528\uff0c\u65e5\u672c\u51fa\u53f0\u4e24\u90e8\u5173\u952e\u6027\u6cd5\u5f8b\uff0c\u653e\u5bbd\u533b\u7597\u6570\u636e\u4f7f\u7528\u9650\u5236<\/strong><\/span><\/p>\n<div id=\"_idContainer061\" class=\"Basic-Text-Frame\" style=\"text-align: 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class=\"Normal\" style=\"text-align: justify;\"><span style=\"color: #bd1a24;\"><strong><span class=\"CharOverride-16\">\u6cd5\u5f8b\u5bf9\u4f7f\u7528\u533b\u7597\u6570\u636e\u7684\u9650\u5236<\/span><\/strong><\/span><\/h2>\n<figure id=\"attachment_585417\" aria-describedby=\"caption-attachment-585417\" style=\"width: 200px\" class=\"wp-caption alignright\"><img class=\"size-full wp-image-585417\" src=\"https:\/\/beta3.law.asia\/wp-content\/uploads\/2025\/05\/Mika-Okada-City-Yuwa-Partners.jpg\" alt=\"Mika Okada, City-Yuwa Partners\" width=\"200\" height=\"250\" \/><figcaption id=\"caption-attachment-585417\" class=\"wp-caption-text\"><strong>\u5188\u7530\u7f8e\u9999<\/strong><br \/>\u5408\u4f19\u4eba<br \/>City-Yuwa Partners<br \/>\u4e1c\u4eac<br \/>\u7535\u8bdd: +81 3 6212 5527<br \/>\u90ae\u7bb1: mika.okada@city-yuwa.com<\/figcaption><\/figure>\n<p>\u300a\u4e2a\u4eba\u4fe1\u606f\u4fdd\u62a4\u6cd5\u300b\u7684\u754c\u5b9a\u3002\u533b\u7597\u4fe1\u606f\u901a\u5e38\u5305\u542b\u75c5\u53f2\uff0c\u8fd9\u5c5e\u4e8eAPPI\u5b9a\u4e49\u7684\u201c\u654f\u611f\u4e2a\u4eba\u4fe1\u606f\u201d\u3002\u8be5\u6cd5\u5bf9\u8fd9\u7c7b\u654f\u611f\u4e2a\u4eba\u4fe1\u606f\u7684\u4f7f\u7528\u6709\u4e25\u683c\u9650\u5236\u3002\u4f8b\u5982\uff0c\u6b64\u7c7b\u654f\u611f\u4e2a\u4eba\u4fe1\u606f\u4e0d\u80fd\u901a\u8fc7\u201c\u9009\u62e9\u9000\u51fa\u201d\uff08opt-out\uff09\u7a0b\u5e8f\u4e0e\u7b2c\u4e09\u65b9\u5171\u4eab\uff0c\u5fc5\u987b\u4e8b\u5148\u83b7\u5f97\u4e2a\u4eba\u7684\u660e\u786e\u540c\u610f\u3002<\/p>\n<p>APPI\u4ec5\u89c4\u5b9a\u4e86\u51e0\u4e2a\u4f8b\u5916\u60c5\u5f62\uff0c\u5305\u62ec\uff1a\uff081\uff09\u51fa\u4e8e\u6539\u5584\u516c\u5171\u536b\u751f\u6216\u4fc3\u8fdb\u513f\u7ae5\u5065\u5eb7\u6210\u957f\u7684\u7279\u6b8a\u9700\u8981\u4f7f\u7528\u533b\u7597\u4fe1\u606f\uff1b\u4ee5\u53ca\uff082\uff09\u51fa\u4e8e\u5b66\u672f\u7814\u7a76\u76ee\u7684\u4f7f\u7528\uff0c\u4e14\u8fd9\u4e9b\u4f8b\u5916\u7684\u9002\u7528\u8303\u56f4\u5e76\u4e0d\u5e7f\u6cdb\u3002<\/p>\n<p>\u5373\u4fbf\u5728\u6cd5\u5b9a\u7684\u4f8b\u5916\u60c5\u5f62\u4e0b\uff0c\u4f7f\u7528\u533b\u7597\u4fe1\u606f\u4e5f\u987b\u83b7\u5f97\u4e2a\u4eba\u540c\u610f\uff0c\u800c\u8fd9\u5728\u5b9e\u9645\u64cd\u4f5c\u4e2d\u8f83\u4e3a\u56f0\u96be\uff0c\u5e76\u4e14\u5982\u679c\u533b\u7597\u4fe1\u606f\u88ab\u7528\u4e8e\u4ea7\u54c1\u5f00\u53d1\uff0c\u8fd9\u4e9b\u4f8b\u5916\u5e76\u4e0d\u9002\u7528\u3002<\/p>\n<p>\u533f\u540d\u5316\u4e0e\u5047\u540d\u5316\u533b\u7597\u4fe1\u606f\u3002APPI\u8bbe\u7f6e\u7684\u590d\u6742\u4e14\u4e25\u683c\u7684\u9650\u5236\u963b\u788d\u4e86\u533b\u7597\u4fe1\u606f\u7684\u4f7f\u7528\u3002\u800c\u533b\u7597\u4fe1\u606f\u672c\u53ef\u4f5c\u4e3a\u63d0\u5347\u533b\u7597\u670d\u52a1\u8d28\u91cf\u548c\u4fc3\u8fdb\u533b\u5b66\u7814\u7a76\u7684\u91cd\u8981\u8d44\u6e90\u3002\u4e3a\u89e3\u51b3\u8fd9\u4e00\u95ee\u9898\uff0c\u65e5\u672c\u9881\u5e03\u300a\u4e3a\u533b\u5b66\u7814\u7a76\u4e0e\u53d1\u5c55\u4f7f\u7528\u533f\u540d\u533b\u7597\u6570\u636e\u6cd5\u300b\uff0c\u6b63\u5f0f\u540d\u79f0\u4e3a\u300a\u4e0b\u4e00\u4ee3\u533b\u7597\u57fa\u7840\u8bbe\u65bd\u6cd5\u300b\uff08NGMIL\uff09\uff0c\u4f5c\u4e3aAPPI\u4e0b\u7684\u7279\u522b\u6cd5\u3002<\/p>\n<p>NGMIL\u5f15\u5165\u4e86\u201c\u533f\u540d\u5316\u533b\u7597\u4fe1\u606f\u201d\u7684\u6982\u5ff5\uff0c\u8fd9\u4e9b\u4fe1\u606f\u5fc5\u987b\u7531\u7ecf\u4e3b\u7ba1\u673a\u5173\u8ba4\u8bc1\u3001\u5177\u5907\u53ef\u9760\u533f\u540d\u5316\u6280\u672f\u7684\u7279\u5b9a\u673a\u6784\uff08\u8ba4\u8bc1\u533f\u540d\u5316\u533b\u7597\u4fe1\u606f\u5904\u7406\u673a\u6784\uff09\u8fdb\u884c\u533f\u540d\u5316\u5904\u7406\u3002\u533b\u7597\u673a\u6784\u53ef\u4ee5\u901a\u8fc7\u201c\u9009\u62e9\u9000\u51fa\u201d\u7a0b\u5e8f\uff0c\u5c06\u533b\u7597\u4fe1\u606f\u63d0\u4f9b\u7ed9\u8fd9\u4e9b\u4fe1\u606f\u5904\u7406\u673a\u6784\uff0c\u65e0\u987b\u4e8b\u5148\u83b7\u5f97\u60a3\u8005\u7684\u660e\u786e\u540c\u610f\u3002\u4fe1\u606f\u5904\u7406\u673a\u6784\u968f\u540e\u5bf9\u533b\u7597\u4fe1\u606f\u8fdb\u884c\u533f\u540d\u5316\u5904\u7406\uff0c\u5e76\u5c06\u5904\u7406\u540e\u7684\u4fe1\u606f\u63d0\u4f9b\u7ed9\u7814\u7a76\u673a\u6784\u6216\u5236\u836f\u516c\u53f8\u3002\u4e0d\u8fc7\uff0c\u7531\u4e8e\u533f\u540d\u5316\u8fc7\u7a0b\u8981\u6c42\u5220\u9664\u90e8\u5206\u533b\u7597\u6570\u636e\uff0c\u5e76\u975e\u6240\u6709\u533f\u540d\u5316\u533b\u7597\u4fe1\u606f\u90fd\u6709\u7528\u3002<\/p>\n<figure id=\"attachment_585433\" aria-describedby=\"caption-attachment-585433\" style=\"width: 200px\" class=\"wp-caption alignright\"><img class=\"size-full wp-image-585433\" src=\"https:\/\/beta3.law.asia\/wp-content\/uploads\/2025\/05\/Kosuke-Hasegawa-City-Yuwa-Partners.jpg\" alt=\"Kosuke Hasegawa, City-Yuwa Partners\" width=\"200\" height=\"250\" \/><figcaption id=\"caption-attachment-585433\" class=\"wp-caption-text\"><strong>\u957f\u8c37\u5ddd\u516c\u4eae<\/strong><br \/>\u5408\u4f19\u4eba<br \/>City-Yuwa Partners<br \/>\u4e1c\u4eac<br \/>\u7535\u8bdd: +81 3 6212 5641<br \/>\u90ae\u7bb1: kosuke.hasegawa@city-yuwa.com<\/figcaption><\/figure>\n<p>\u4e3a\u89e3\u51b3\u8fd9\u4e00\u95ee\u9898\uff0cNGMIL\u4e8e2023\u5e745\u6708\u7ecf\u8fc7\u8fdb\u4fee\u8ba2\uff0c\u5f15\u5165\u4e86\u201c\u5047\u540d\u5316\u533b\u7597\u4fe1\u606f\u201d\u7684\u6982\u5ff5\u3002\u5047\u540d\u5316\u533b\u7597\u4fe1\u606f\u5728\u4f7f\u7528\u65f6\u65e0\u987b\u5220\u9664\u4efb\u4f55\u533b\u7597\u6570\u636e\uff0c\u56e0\u6b64\u7528\u4e8e\u4ee5\u4e0b\u4f5c\u9014\uff1a<\/p>\n<ol>\n<li>\u63d0\u4f9b\u7f55\u89c1\u75be\u75c5\u76f8\u5173\u6570\u636e\uff1b<\/li>\n<li>\u63d0\u4f9b\u9488\u5bf9\u540c\u4e00\u76ee\u6807\u7fa4\u4f53\u7684\u6301\u7eed\u6027\u548c\u53d1\u5c55\u6027\u6570\u636e\uff1b<\/li>\n<li>\u901a\u8fc7\u56de\u6eaf\u539f\u59cb\u6570\u636e\u8fdb\u884c\u771f\u5b9e\u6027\u9a8c\u8bc1\uff0c\u4ece\u800c\u8bc1\u660e\u6570\u636e\u7684\u53ef\u9760\u6027\uff0c\u8fd9\u662f\u836f\u54c1\u7533\u62a5\u7684\u4e00\u4e2a\u5fc5\u8981\u6761\u4ef6\u3002<\/li>\n<\/ol>\n<p>\u4fee\u8ba2\u540e\u7684NGMIL\u5141\u8bb8\u5047\u540d\u5316\u533b\u7597\u4fe1\u606f\u4e0e\u56fd\u5bb6\u5065\u5eb7\u4fdd\u9669\u7d22\u8d54\u4e0e\u4e13\u4e1a\u5065\u5eb7\u68c0\u67e5\u6570\u636e\u5e93\u8fdb\u884c\u5173\u8054\u5206\u6790\u3002\u5047\u540d\u5316\u533b\u7597\u4fe1\u606f\u540c\u6837\u5fc5\u987b\u7531\u7ecf\u4e3b\u7ba1\u673a\u5173\u8ba4\u8bc1\u7684\u7279\u5b9a\u673a\u6784\u5904\u7406\uff0c\u4e14\u4f7f\u7528\u5047\u540d\u5316\u533b\u7597\u4fe1\u606f\u7684\u7ecf\u8425\u8005\u4e5f\u987b\u83b7\u5f97\u4e3b\u7ba1\u673a\u5173\u7684\u8ba4\u8bc1\u3002<\/p>\n<p>APPI\u4fee\u8ba2\u3002\u653f\u5e9c\u5b9a\u671f\u68c0\u8ba8\u4fee\u8ba2APPI\u3002\u76ee\u524d\uff0c\u4e2a\u4eba\u4fe1\u606f\u4fdd\u62a4\u59d4\u5458\u4f1a\u6b63\u5728\u8ba8\u8bba\u5bf9APPI\u8fdb\u884c\u8fdb\u4e00\u6b65\u4fee\u8ba2\uff0c\u62df\u653e\u5bbd\u7279\u5b9a\u60c5\u51b5\u4e0b\uff08\u4f8b\u5982\uff0c\u4ec5\u4e3a\u7f16\u5236\u7edf\u8ba1\u6570\u636e\u4f7f\u7528\u4e2a\u4eba\u4fe1\u606f\uff09\u4f7f\u7528\u4e2a\u4eba\u6570\u636e\u7684\u8981\u6c42\u3002<\/p>\n<h2 class=\"Normal\" style=\"text-align: justify;\"><span style=\"color: #bd1a24;\"><strong><span class=\"CharOverride-16\">\u5bf9\u65b0\u6280\u672f\u7684\u76d1\u7ba1<\/span><\/strong><\/span><\/h2>\n<p>\u533b\u7597\u5668\u68b0\u8f6f\u4ef6\uff08SaMD\uff09\u3002\u73b0\u5728\uff0c\u8bb8\u591a\u533b\u7597\u5065\u5eb7\u5e94\u7528\u7a0b\u5e8f\u90fd\u53ef\u4ee5\u5728\u667a\u80fd\u624b\u673a\u3001\u667a\u80fd\u624b\u8868\u53ca\u5176\u4ed6\u6570\u5b57\u8bbe\u5907\u4e0a\u4f7f\u7528\u3002\u5176\u4e2d\u90e8\u5206\u5e94\u7528\u7a0b\u5e8f\u53ef\u80fd\u5c5e\u4e8e\u300a\u836f\u54c1\u3001\u533b\u7597\u5668\u68b0\u548c\u5176\u4ed6\u4ea7\u54c1\u8d28\u91cf\u3001\u529f\u52b9\u53ca\u5b89\u5168\u4fdd\u969c\u6cd5\u300b\uff08PMD\u6cd5\uff09\u76d1\u7ba1\u7684\u533b\u7597\u5668\u68b0\u3002<\/p>\n<p>\u5177\u6709\u533b\u7597\u7528\u9014\uff08\u5982\u8bca\u65ad\u3001\u6cbb\u7597\u6216\u9884\u9632\u75be\u75c5\uff09\u7684\u8f6f\u4ef6\uff0c\u5982\u679c\u51fa\u73b0\u7f3a\u9677\uff0c\u53ef\u80fd\u5f71\u54cd\u60a3\u8005\u6216\u7528\u6237\u751f\u547d\u6216\u5065\u5eb7\uff0c\u90a3\u4e48\u8be5\u8f6f\u4ef6\u5c06\u88ab\u89c6\u4e3aPMD\u6cd5\u76d1\u7ba1\u7684\u533b\u7597\u5668\u68b0\u3002<\/p>\n<figure id=\"attachment_585438\" aria-describedby=\"caption-attachment-585438\" style=\"width: 200px\" class=\"wp-caption alignright\"><img class=\"size-full wp-image-585438\" src=\"https:\/\/beta3.law.asia\/wp-content\/uploads\/2025\/05\/Yudai-Oka-City-Yuwa-Partners.jpg\" alt=\"Yudai Oka, City-Yuwa Partners\" width=\"200\" height=\"250\" \/><figcaption id=\"caption-attachment-585438\" class=\"wp-caption-text\"><strong>\u5188\u4f51\u5927<\/strong><br \/>\u5f8b\u5e08<br \/>City-Yuwa Partners<br \/>\u4e1c\u4eac<br \/>\u7535\u8bdd: +81 3 6212 5655<br \/>\u90ae\u7bb1: yudai.oka@city-yuwa.com<\/figcaption><\/figure>\n<p>\u6b64\u7c7b\u8f6f\u4ef6\u987b\u83b7\u5f97\u4e0a\u5e02\u8bb8\u53ef\u6216\u8ba4\u8bc1\uff0c\u4e14\u9500\u552e\u8be5\u7c7b\u8f6f\u4ef6\u7684\u516c\u53f8\u5fc5\u987b\u6839\u636ePMD\u6cd5\u53d6\u5f97\u76f8\u5e94\u7684\u9500\u552e\u4e1a\u52a1\u8bb8\u53ef\u3002\u5224\u65ad\u4e00\u4e2a\u8f6f\u4ef6\u662f\u5426\u5177\u6709\u533b\u7597\u7528\u9014\uff0c\u5c06\u7efc\u5408\u8003\u8651\u4ea7\u54c1\u6027\u80fd\u3001\u76ee\u6807\u7528\u6237\u6807\u7b7e\u3001\u4f7f\u7528\u89c4\u5219\u3001\u5e7f\u544a\u7b49\u56e0\u7d20\u3002<\/p>\n<p>\u539a\u751f\u52b3\u52a8\u7701\uff08MHLW\uff09\u5df2\u53d1\u5e03\u5173\u4e8e\u7a0b\u5e8f\u7c7b\u533b\u7597\u5668\u68b0\u9002\u7528\u6027\u7684\u6307\u5bfc\u65b9\u9488\uff0c\u5c31\u5982\u4f55\u5224\u65ad\u67d0\u6b3e\u8f6f\u4ef6\u662f\u5426\u5c5e\u4e8e\u533b\u7597\u5668\u68b0\u4f5c\u51fa\u8bf4\u660e\u3002<\/p>\n<p>MHLW\u8fd8\u53d1\u5e03\u4e86\u5173\u4e8e\u8f6f\u4ef6\u4f5c\u4e3a\u533b\u7597\u5668\u68b0\u9002\u7528\u6027\u7684\u5178\u578b\u6848\u4f8b\uff0c\u5efa\u7acb\u4e86\u4e00\u4e2aSaMD\u6570\u636e\u5e93\u3002\u4f01\u4e1a\u53ef\u5c31\u533b\u7597\u5668\u68b0\u9002\u7528\u6027\u5411MHLW\u7684\u76f8\u5173\u90e8\u95e8\u8fdb\u884c\u54a8\u8be2\uff0c\u53e6\u5916\uff0c\u836f\u54c1\u4e0e\u533b\u7597\u5668\u68b0\u7f72\u4e5f\u63d0\u4f9b\u4e0eSaMD\u76f8\u5173\u7684\u4e00\u7ad9\u5f0f\u54a8\u8be2\u670d\u52a1\u3002<\/p>\n<p>AI\u6280\u672f\u7684\u5e94\u7528\u3002AI\u5df2\u5e7f\u6cdb\u5e94\u7528\u4e8e\u8bca\u65ad\u548c\u533b\u7597\u8f85\u52a9\u3002\u7531\u4e8e\u300a\u533b\u5e08\u6cd5\u300b\u7b2c17\u6761\u7981\u6b62\u975e\u533b\u5e08\u4ece\u4e8b\u533b\u7597\u6d3b\u52a8\uff0c\u5982\u679c\u79ef\u6781\u8fd0\u7528AI\u8bca\u65ad\u7cfb\u7edf\u4f5c\u6700\u7ec8\u533b\u7597\u8bca\u65ad\uff0c\u6d89\u5acc\u8fdd\u53cd\u8be5\u6cd5\u3002<\/p>\n<p>\u5bf9\u4e8e\u8fd9\u4e2a\u95ee\u9898\uff0cMHLW\u4e8e2018\u5e7412\u670819\u65e5\u53d1\u5e03\u4e86\u6307\u5bfc\u610f\u89c1\uff0c\u6f84\u6e05\u5177\u6709\u8f85\u52a9\u8bca\u65ad\u3001\u6cbb\u7597\u7b49\u529f\u80fd\u7684AI\u7a0b\u5e8f\u7684\u5e94\u7528\u662f\u5426\u8fdd\u53cd\u300a\u533b\u5e08\u6cd5\u300b\u7b2c17\u6761\uff0c\u610f\u89c1\u660e\u786e\u6307\u51fa\uff0c\u5982\u679cAI\u7a0b\u5e8f\u4ec5\u4f5c\u4e3a\u8f85\u52a9\u5de5\u5177\u652f\u6301\u8bca\u65ad\uff0c\u6700\u7ec8\u8bca\u65ad\u4e3b\u8981\u7531\u533b\u5e08\u4f5c\u51fa\uff0c\u90a3\u4e48\u8fd9\u6837\u7684\u884c\u4e3a\u4e0d\u8fdd\u53cd\u300a\u533b\u5e08\u6cd5\u300b\u7b2c17\u6761\u3002\u6240\u4ee5\uff0c\u5728\u65e5\u672c\u63d0\u4f9b\u57fa\u4e8eAI\u7684\u533b\u7597\u670d\u52a1\u65f6\uff0c\u5fc5\u987b\u8003\u8651\u8fd9\u4e2a\u6cd5\u6761\u3002<\/p>\n<p>2024\u5e7412\u670825\u65e5\uff0c\u7ecf\u6d4e\u4ea7\u4e1a\u7701\uff08METI\uff09\u4e0e\u603b\u52a1\u7701\u8054\u5408\u53d1\u5e03\u4e86\u300aAI\u4e1a\u52a1\u6307\u5f151.01\u7248\u300b\uff0c\u65e8\u5728\u63a8\u52a8AI\u7684\u5e94\u7528\u3002\u65b0\u6307\u5f15\u6574\u5408\u4e86\u6b64\u524d\u5173\u4e8eAI\u7814\u53d1\u3001\u5e94\u7528\u548c\u6cbb\u7406\u7684\u591a\u4efd\u6307\u5f15\uff0c\u5bf9\u4e00\u4e9b\u57fa\u672c\u7684AI\u4f26\u7406\u539f\u5219\uff08\u5982\u900f\u660e\u6027\u3001\u516c\u6b63\u4e0e\u516c\u5e73\u3001\u4ee5\u53ca\u4e0d\u4f5c\u6076\u539f\u5219\uff09\u4f5c\u51fa\u89e3\u91ca\uff0c\u4e3aAI\u5f00\u53d1\u8005\u3001\u63d0\u4f9b\u8005\u548c\u5546\u4e1a\u7528\u6237\u6307\u660e\u65b9\u5411\u3002<\/p>\n<p>METI\u8fd1\u671f\u8fd8\u53d1\u5e03\u4e86\u300aAI\u8fd0\u7528\u4e0e\u5f00\u53d1\u76f8\u5173\u5408\u540c\u6e05\u5355\u300b\uff0c\u4f9b\u4f01\u4e1a\u5728\u7b7e\u8ba2AI\u76f8\u5173\u5408\u540c\u65f6\u53c2\u8003\u4f7f\u7528\u3002<\/p>\n<p>\u5173\u4e8e\u533b\u7597\u5065\u5eb7\u76f8\u5173\u4f01\u4e1a\u7684AI\u6cbb\u7406\uff0c\u7531\u4ece\u4e8b\u6570\u5b57\u5065\u5eb7\u4ea7\u4e1a\u7684\u4fe1\u606f\u901a\u4fe1\u6280\u672f\u516c\u53f8\u3001\u521d\u521b\u4f01\u4e1a\u53ca\u5236\u836f\u548c\u533b\u7597\u5668\u68b0\u5236\u9020\u5546\u7ec4\u6210\u7684\u6570\u5b57\u5065\u5eb7\u8054\u76df\u53d1\u5e03\u4e86\u300a\u533b\u7597\u5065\u5eb7\u4e1a\u52a1\u7ecf\u8425\u8005\u751f\u6210\u5f0fAI\u5e94\u7528\u6307\u53572.0\u7248\u300b\uff0c\u4e3a\u533b\u7597\u673a\u6784\u5f00\u53d1\u548c\u4f7f\u7528\u751f\u6210\u5f0fAI\u76f8\u5173\u4ea7\u54c1\u548c\u670d\u52a1\u63d0\u4f9b\u4e86\u5b9e\u7528\u6307\u5f15\u3002<\/p>\n<p>\u653f\u5e9c\u4e8e2025\u5e742\u6708\u63d0\u4ea4\u4e86\u300a\u5173\u4e8e\u4fc3\u8fdb\u4eba\u5de5\u667a\u80fd\u76f8\u5173\u6280\u672f\u7814\u53d1\u4e0e\u5e94\u7528\u7684\u6cd5\u6848\u300b\uff08AI\u6cd5\u6848\uff09\uff0c\u4e3aAI\u53d1\u5c55\u63d0\u4f9b\u4e86\u56fd\u5bb6\u5c42\u9762\u7684\u6846\u67b6\uff0c\u6cd5\u6848\u5bf9AI\u76f8\u5173\u6280\u672f\u4f5c\u51fa\u5b9a\u4e49\uff0c\u8fdb\u4e00\u6b65\u8981\u6c42\u5229\u7528AI\u76f8\u5173\u6280\u672f\u7684\u4f01\u4e1a\u914d\u5408\u653f\u5e9c\u5b9e\u65bd\u7684\u76f8\u5173\u63aa\u65bd\u3002AI\u6cd5\u6848\u9884\u8ba1\u5c06\u4e8e2025\u5e74\u7b2c\u56db\u5b63\u5ea6\u5728\u56fd\u4f1a\u83b7\u5f97\u901a\u8fc7\u3002<\/p>\n<section class=\"format-info\">\n<p style=\"text-align: justify;\"><strong><img class=\"aligncenter wp-image-572979 \" src=\"https:\/\/beta3.law.asia\/wp-content\/uploads\/2024\/07\/Logo-3-scaled.jpg\" alt=\"City-Yuwa Partners\" width=\"395\" height=\"94\" \/>CITY-YUWA PARTNERS<\/strong><br \/>\nMarunouchi Mitsui Building<br \/>\n2-2-2 Marunouchi, Chiyoda-ku,<br \/>\nTokyo 100-0005, Japan<\/p>\n<p data-pm-slice=\"1 1 []\">\u7535\u8bdd: +81 3 6212 5500<\/p>\n<p data-pm-slice=\"1 1 []\">\u90ae\u7bb1: +81 3 6212 5700<br \/>\n<a href=\"https:\/\/www.city-yuwa.com\/global\/en\/\">www.city-yuwa.com\/global\/en\/<\/a><\/p>\n<\/section>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>\u4e3a\u63a8\u52a8\u533b\u7597\u6570\u636e\u7684\u5e94\u7528\uff0c\u65e5\u672c\u51fa\u53f0\u4e24\u90e8\u5173\u952e\u6027\u6cd5\u5f8b\uff0c\u653e\u5bbd\u533b\u7597\u6570\u636e\u4f7f\u7528\u9650\u5236 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