[et_pb_section fb_built=”1″ theme_builder_area=”post_content” _builder_version=”4.27.9″ _module_preset=”default”][et_pb_row _builder_version=”4.27.9″ _module_preset=”default” theme_builder_area=”post_content” width=”100%” hover_enabled=”0″ sticky_enabled=”0″][et_pb_column _builder_version=”4.27.9″ _module_preset=”default” type=”4_4″ theme_builder_area=”post_content”][et_pb_text _builder_version=”4.27.9″ _module_preset=”default” theme_builder_area=”post_content” text_orientation=”justified” hover_enabled=”0″ sticky_enabled=”0″]The preparation of regulatory dossiers will become an increasingly relevant consideration for pharmaceutical companies marketing medicinal products in Colombia. The progressive implementation of the CTD (Common Technical Document) format introduces new challenges regarding the organization and presentation of the information supporting applications for biological and chemically synthesized medicinal products.<\/p>\n
This format, which is used internationally to structure the technical and scientific documentation for medicinal products, is intended to facilitate a more standardized presentation of regulatory dossiers. In Colombia, its implementation means that companies will need to pay particular attention to document preparation, information classification, and the selection of the appropriate procedure through INVIMA\u2019s digital channels.<\/p>\n
As part of this process, the health authority has introduced adjustments to its Virtual Office to facilitate the identification of procedures, consultation of applicable fees, and submission of supporting documents. According to information published by the Institute, these improvements are being implemented gradually and, for the time being, the current requirements for each procedure remain in place.<\/p>\n
For regulatory affairs teams, this scenario provides an opportunity to review internal procedures, identify potential documentation gaps, and prepare dossiers during the transition period while the new format moves toward becoming a mandatory requirement. It will also be important to monitor the guidance issued by INVIMA and participate in the support and guidance activities planned for the pharmaceutical sector.<\/p>\n
Companies that need to initiate a procedure may access INVIMA\u2019s Virtual Office, where they should select the applicable procedure and verify its filing requirements. A preliminary review of the requirements, supporting documentation, and applicable fee can help prevent errors and unnecessary rework.<\/p>\n
More than a change in format, the transition to the CTD provides an opportunity to strengthen document management and regulatory planning, with the aim of achieving more consistent dossiers and standardized submission processes.[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":"
The implementation of the CTD format introduces challenges regarding the presentation of the information supporting the applications of medicinal products<\/p>\n","protected":false},"author":5,"featured_media":4431301,"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,"footnotes":""},"categories":[59,109],"tags":[],"class_list":["post-4431300","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-newsletter-en","category-regulatory-affairs"],"yoast_head":"\n