Despite their potential, phage therapy still lacks a regulatory framework in the European Union that is fully adapted to its specific nature. The European Medicines Agency currently classifies these products as medicinal products.
Although there is not yet dedicated European legislation for the use of bacteriophages in humans, efforts are underway in this direction:
\u2022 The publication of General Chapter 5.31 of the European Pharmacopoeia, which sets quality standards applicable to PTMPs;
\u2022 The EMA’s draft guideline on the development and manufacture of phage therapy medicinal products, currently in the Concept Paper stage;
\u2022 Belgium’s pioneering example with its Magistral Phage Framework<\/em>, which allows for the individualized preparation of phage-based products in hospital pharmacies.<\/p>\n
Phage Therapy Approved in Portugal<\/strong><\/p>\n Portugal recently took a decisive step by establishing a national regulatory framework for the hospital use of bacteriophages. Deliberation No. 112\/CD\/2024, published by INFARMED, I.P. on November 15, 2024, defines the conditions under which these products may be used in a clinical setting, as magistral preparations.<\/p>\n This decision stems from the growing need for effective alternative solutions to treat resistant infections, while ensuring the safety, quality, and monitoring of these treatments. Accordingly: With this measure, Portugal joins other pioneering European countries in recognizing bacteriophages as a valid therapeutic option, provided their use is properly controlled and clinically justified.<\/p>\n [\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ custom_padding_last_edited=”on|tablet” admin_label=”Drive Footer – Grace” _builder_version=”4.19.5″ _module_preset=”default” background_enable_color=”off” background_image=”https:\/\/all4compliance.pt\/wp-content\/uploads\/2023\/02\/All4coplince-1-50.png” background_blend=”multiply” custom_padding=”45px||14px||false|false” custom_padding_tablet=”30px||0px||false|false” custom_padding_phone=”||||false|false” global_module=”376224″ saved_tabs=”all” locked=”off” collapsed=”off” global_colors_info=”{}”][et_pb_row column_structure=”1_3,1_3,1_3″ admin_label=”Drive Footer – Grace – Row” _builder_version=”4.19.5″ _module_preset=”default” width=”90%” max_width=”1170px” custom_padding=”||40px||false|false” global_colors_info=”{}” body_link_text_color__hover=”#fafafa” body_link_text_color__hover_enabled=”on|hover”][et_pb_column type=”1_3″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_image src=”https:\/\/all4compliance.pt\/wp-content\/uploads\/2023\/02\/logo-footer-final.png” title_text=”logo-footer-final” _builder_version=”4.19.5″ _module_preset=”default” width=”95%” global_colors_info=”{}”][\/et_pb_image][\/et_pb_column][et_pb_column type=”1_3″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_blurb title=”Address” content_max_width=”100%” admin_label=”Drive Footer – Grace – Address” _builder_version=”4.23.1″ _module_preset=”default” header_font=”Poppins||||||||” header_text_color=”#ffffff” header_line_height=”120%” body_font=”Barlow||||||||” body_text_color=”#FFFFFF” body_font_size=”16px” body_line_height=”165%” body_link_font=”||||||||” body_link_text_color=”#999999″ body_link_font_size=”16px” custom_margin=”||14px|||” global_colors_info=”{}” body_link_text_color__hover_enabled=”on|hover” body_link_text_color__hover=”#d7b994″]<\/p>\n Biocant Park | N\u00facleo 04 Lote 2 | Quality Policy<\/a><\/p>\n [\/et_pb_blurb][\/et_pb_column][et_pb_column type=”1_3″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_blurb title=”Social Media” content_max_width=”100%” admin_label=”Drive Footer – Grace – Address” _builder_version=”4.20.4″ _module_preset=”default” header_font=”Poppins||||||||” header_text_color=”#ffffff” header_line_height=”120%” body_font=”Barlow||||||||” body_text_color=”#999999″ body_font_size=”16px” body_line_height=”165%” body_link_font=”||||||||” body_link_text_color=”#999999″ body_link_font_size=”16px” custom_margin=”||14px|||” global_colors_info=”{}” body_link_text_color__hover_enabled=”on|hover” body_link_text_color__hover=”#d7b994″][\/et_pb_blurb][et_pb_social_media_follow icon_color=”#ffffff” use_icon_font_size=”on” icon_font_size=”23px” icon_font_size_tablet=”18px” icon_font_size_phone=”18px” icon_font_size_last_edited=”on|tablet” admin_label=”Drive Footer – Grace – Social Media Follow” _builder_version=”4.19.5″ _module_preset=”default” text_orientation=”left” custom_margin=”||6px|||” text_orientation_tablet=”left” text_orientation_phone=”left” text_orientation_last_edited=”on|tablet” global_colors_info=”{}” icon_color__hover_enabled=”on|hover” icon_color__hover=”#d7b994″][et_pb_social_media_follow_network social_network=”linkedin” _builder_version=”4.19.2″ _module_preset=”default” background_color=”#007bb6″ background_enable_color=”off” global_colors_info=”{}” follow_button=”off” url_new_window=”on”]linkedin[\/et_pb_social_media_follow_network][et_pb_social_media_follow_network social_network=”rss” _builder_version=”4.19.4″ _module_preset=”default” background_enable_color=”off” global_colors_info=”{}” follow_button=”off” url_new_window=”on”]rss[\/et_pb_social_media_follow_network][\/et_pb_social_media_follow][et_pb_button button_url=”\/en\/contacts\/” button_text=”Contact us” button_alignment=”left” _builder_version=”4.20.4″ _module_preset=”default” custom_button=”on” button_text_size=”17px” button_text_color=”#FFFFFF” button_bg_color=”#56a09a” button_border_color=”#56a09a” button_border_radius=”50px” global_colors_info=”{}”][\/et_pb_button][\/et_pb_column][\/et_pb_row][et_pb_row admin_label=”Drive Footer – Grace – Row” _builder_version=”4.16″ _module_preset=”default” width=”90%” max_width=”1170px” border_width_top=”1px” border_color_top=”#FFFFFF” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_text admin_label=”Drive Footer – Grace – Copyright \u00a9” _builder_version=”4.20.4″ _module_preset=”default” text_font=”Barlow||||||||” text_text_color=”#FFFFFF” text_font_size=”16px” text_orientation=”center” custom_css_main_element=”font-weight: 400;” global_colors_info=”{}”]\u00a9 All4Compliance, All rights reserved. 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\u2022 Bacteriophages can be used in specific cases, outside the traditional marketing authorization route;
\u2022 Their preparation must follow strict quality criteria;
\u2022 Ongoing monitoring of their clinical use is required, including data on efficacy, adverse events, and patient response.<\/p>\n![\"\"](\"https:\/\/all4compliance.pt\/wp-content\/uploads\/2025\/04\/phages_en-scaled.png\")
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Portugal<\/p>\n