[et_pb_section fb_built=”1″ theme_builder_area=”post_content” _builder_version=”4.27.6″ _module_preset=”default”][et_pb_row _builder_version=”4.27.6″ _module_preset=”default” theme_builder_area=”post_content” width=”100%” hover_enabled=”0″ sticky_enabled=”0″][et_pb_column _builder_version=”4.27.6″ _module_preset=”default” type=”4_4″ theme_builder_area=”post_content”][et_pb_text _builder_version=”4.27.6″ _module_preset=”default” theme_builder_area=”post_content” hover_enabled=”0″ sticky_enabled=”0″]The INVIMA has issued a new Contingency Plan aimed at rationalizing, simplifying, and automating the processes for the issuance and modification of marketing authorizations and related procedures handled by the Directorate of Medicines and Biological Products. The measure arises in response to the high volume of pending procedures (more than 12,400 as of May 19, 2026) and seeks to strengthen regulatory efficiency through an approach based on health risk, post-market control, digitalization, and regulatory reliance.<\/p>\n
The Resolution incorporates automation tools, the gradual use of artificial intelligence, evaluation methodologies through interdisciplinary \u201cworking cells,\u201d and prioritization mechanisms for procedures related to the risk of medicine shortages. Likewise, it maintains the obligation to fully comply with the technical, pharmaceutical, and health requirements established under current regulations, expressly clarifying that the Plan does not modify the substantive regulatory standards.<\/p>\n
One of the most relevant aspects corresponds to Article 8, through which INVIMA formally adopts the principles of \u201cregulatory trust and reliance.\u201d This provision establishes that new marketing authorizations that have received prior approval from reference health authorities may be prioritized within the Institute\u2019s evaluation system. Nevertheless, the regulation expressly clarifies that INVIMA will retain the substantive assessment and final administrative decision in all cases.<\/p>\n
Additionally, the Resolution provides that, within one month following its entry into force, INVIMA will issue the legal instrument regulating the use of regulatory decisions from other jurisdictions. This mechanism will allow the use of technical assessments issued by foreign regulatory agencies to optimize resources and strengthen national regulatory decision-making, in line with international trends toward regulatory convergence and reliance.<\/p>\n
Unlike the contingency plans issued by INVIMA in 2025, which were primarily focused on the prioritization of procedures related to medicine shortages and operational strengthening, the new 2026 Plan introduces a more structured and modern regulatory approach by formally incorporating the principle of \u201cReliance\u201d or regulatory trust as a tool to optimize and prioritize the evaluation of procedures that have received prior approvals from reference health authorities.[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":"
INVIMA issued a Contingency Plan aimed at rationalizing, simplifying, and automating the processes for the issuance and modification of marketing authorizations<\/p>\n","protected":false},"author":5,"featured_media":4428709,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"","_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[59,109],"tags":[],"class_list":["post-4428708","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-newsletter-en","category-regulatory-affairs"],"yoast_head":"\n