{"id":10727,"date":"2026-01-29T11:00:16","date_gmt":"2026-01-29T10:00:16","guid":{"rendered":"https:\/\/oytec.es\/?p=10727"},"modified":"2026-06-16T17:17:07","modified_gmt":"2026-06-16T15:17:07","slug":"10-principles-pharmaceutical-ai-ema-fda-2026","status":"publish","type":"post","link":"https:\/\/www.oytec.es\/en\/10-principles-pharmaceutical-ai-ema-fda-2026\/","title":{"rendered":"EMA and FDA: The 10 Principles of Pharmaceutical AI"},"content":{"rendered":"

[et_pb_section fb_built=”1″ _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_row _builder_version=”4.27.4″ _module_preset=”default” custom_padding=”2px|||||” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.27.5″ _module_preset=”default” text_font=”Montserrat||||||||” header_font=”Montserrat||||||||” header_text_align=”justify” header_font_size=”14px” text_orientation=”justified” global_colors_info=”{}”]The European Union and the United States published the Guiding Principles for Good AI Practices in Drug Development<\/strong><\/em>\u00a0on January 14, 2026, as part of a strategic effort to harmonize regulatory criteria. The EMA-FDA collaborative work initiative has the mission of promoting safety and accountability in the use of Artificial Intelligence with the aim of leveraging data, digitalization, and AI.<\/p>\n

This work has been analyzed and disseminated by por Guillem L\u00f3pez<\/strong>, CSV & QA Manager <\/strong>at\u00a0OYTEC<\/strong>, author of the article “The 10 Principles of Pharmaceutical AI according to the EMA and FDA”<\/strong><\/a>.
\n[\/et_pb_text][et_pb_image src=”https:\/\/oytec.es\/wp-content\/uploads\/Picture1-1843×1080.png” title_text=”IA-FDA-EMA-graphic” align=”center” _builder_version=”4.27.4″ _module_preset=”default” width=”45%” module_alignment=”center” global_colors_info=”{}”][\/et_pb_image][et_pb_text ol_item_indent=”40px” _builder_version=”4.27.4″ _module_preset=”default” text_font=”Montserrat||||||||” ul_font=”Montserrat||||||||” ol_font=”Montserrat|–et_global_body_font_weight|||||||” ol_text_align=”justify” ol_line_height=”2em” header_2_font=”Montserrat||||||||” header_2_text_align=”justify” text_orientation=”justified” global_colors_info=”{}”]<\/p>\n

Common Framework, Different Execution<\/h2>\n

The alignment of criteria between both regulatory agencies aims to guide the use of AI in the pharmaceutical field without hindering innovation. However, when these principles are translated into regulatory draft guidelines, relevant nuances emerge: shared objectives, but different approaches.
\n[\/et_pb_text][et_pb_gallery gallery_ids=”10748,10747″ fullwidth=”on” _builder_version=”4.27.5″ _module_preset=”default” width=”50%” max_width=”100%” module_alignment=”center” box_shadow_style=”preset2″ global_colors_info=”{}”][\/et_pb_gallery][et_pb_text ol_item_indent=”40px” _builder_version=”4.27.5″ _module_preset=”default” text_font=”Montserrat||||||||solid” ul_font=”Montserrat||||||||” ol_font=”Montserrat|–et_global_body_font_weight|||||||” ol_text_align=”justify” ol_line_height=”2em” header_2_font=”Montserrat||||||||” header_2_text_align=”justify” text_orientation=”justified” global_colors_info=”{}”]In the article’s conclusions, L\u00f3pez emphasizes that\u00a0\u201cThe EU-US regulatory alignment in artificial intelligence is already visible and substantial, with a common vision based on risk, context of use, human oversight, data governance, and lifecycle management.\u201d<\/strong> However, he observes differences: the EMA integrates AI into the GMP framework in a preventive and structured manner, while the FDA prioritizes credibility and proportionality to use.<\/p>\n

These principles are set forth in the joint agency document Guiding Principles of Good AI Practice in Drug Development<\/em><\/a>. They are also reflected in the EMA’s draft Annex 22<\/a> and in the FDA’s AI Credibility Framework Guidance.<\/a>
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How OYTEC Implements AI<\/strong><\/h2>\n

OYTEC implements AI solutions in GxP environments alongside technology partners such as Siemens and Aizon<\/strong>, aligning credibility plans and reports with GMP compliance. For further information, you may contact our experts.<\/a><\/p>\n

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