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AI时代审评革命已至,药品注册人职业进化之道

当前时间： 1970-01-01 08:00:00 分类：办公文件 评论(0)
AI时代审评革命已至,药品注册人职业进化之道

当国家药监局正式发布《“人工智能+药品监管”实施意见》，当FDA于2025年12月认证了全球首个AI药物开发工具——AIM-NASH"，当FDA2026年4月宣布将推行AI立卷审查改革，目标将60天压缩至分钟级，一个不可回避的问题摆在每一位注册人面前：在这个算法重塑审评流程的时代...

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  1. CONNECT:[ UseTime:0.000619s ] mysql:host=127.0.0.1;port=3306;dbname=wenku;charset=utf8mb4
  2. SHOW FULL COLUMNS FROM `fenlei` [ RunTime:0.000817s ]
  3. SELECT * FROM `fenlei` WHERE `fid` = 0 [ RunTime:0.000353s ]
  4. SELECT * FROM `fenlei` WHERE `fid` = 63 [ RunTime:0.000316s ]
  5. SHOW FULL COLUMNS FROM `set` [ RunTime:0.000526s ]
  6. SELECT * FROM `set` [ RunTime:0.000210s ]
  7. SHOW FULL COLUMNS FROM `article` [ RunTime:0.000569s ]
  8. SELECT * FROM `article` WHERE `id` = 606370 LIMIT 1 [ RunTime:0.000429s ]
  9. UPDATE `article` SET `lasttime` = 1778477260 WHERE `id` = 606370 [ RunTime:0.013241s ]
  10. SELECT * FROM `fenlei` WHERE `id` = 64 LIMIT 1 [ RunTime:0.000288s ]
  11. SELECT * FROM `article` WHERE `id` < 606370 ORDER BY `id` DESC LIMIT 1 [ RunTime:0.000441s ]
  12. SELECT * FROM `article` WHERE `id` > 606370 ORDER BY `id` ASC LIMIT 1 [ RunTime:0.000379s ]
  13. SELECT * FROM `article` WHERE `id` < 606370 ORDER BY `id` DESC LIMIT 10 [ RunTime:0.000662s ]
  14. SELECT * FROM `article` WHERE `id` < 606370 ORDER BY `id` DESC LIMIT 10,10 [ RunTime:0.002651s ]
  15. SELECT * FROM `article` WHERE `id` < 606370 ORDER BY `id` DESC LIMIT 20,10 [ RunTime:0.000922s ]
0.128032s