﻿{"id":21666,"date":"2018-07-18T14:54:10","date_gmt":"2018-07-18T06:54:10","guid":{"rendered":"https:\/\/cdmocmo.ribobio.com\/regulatory-affairs\/"},"modified":"2019-08-22T19:00:49","modified_gmt":"2019-08-22T11:00:49","slug":"regulatory-affairs","status":"publish","type":"page","link":"https:\/\/cdmocmo.ribobio.com\/en\/regulatory-affairs\/","title":{"rendered":"\u836f\u54c1\u6ce8\u518c\u4e8b\u52a1"},"content":{"rendered":"<p>[et_pb_section bb_built=&#8221;1&#8243; _builder_version=&#8221;3.27.2&#8243; background_color=&#8221;#F2F2F2&#8243; custom_padding=&#8221;0px||0px|&#8221; next_background_color=&#8221;#ffffff&#8221; box_shadow_horizontal_tablet=&#8221;0px&#8221; box_shadow_vertical_tablet=&#8221;0px&#8221; box_shadow_blur_tablet=&#8221;40px&#8221; box_shadow_spread_tablet=&#8221;0px&#8221; z_index_tablet=&#8221;500&#8243; global_module=&#8221;22006&#8243;][et_pb_row global_parent=&#8221;22006&#8243; column_structure=&#8221;1_3,1_3,1_3&#8243; module_class=&#8221;icon_list&#8221; 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