Do you need to \u2018Trigger\u2019 an eCTD solution? Helping finger is at hand!<\/p>\n\n\n\n
SAHPRA is in the process of streamline the review process for eCTD format regulatory dossier submissions. This involves an upgrade from eCTD version 2.1 to version 3.0 with changes in the South African regional section and the introduction of an internet portal. It promises significant benefits for regulatory \u2018Applicants\u2019.<\/p>\n\n\n\n
This change is taking place over the period 2024-04-16 to 2024-07-01 when SAHPRA\u2019s new internet portal is scheduled to launch and 2024-10-01 which is the scheduled cut-off date for eCTD dossiers and dossier amendments in the 2.1 format.<\/p>\n\n\n\n
During this transition eCTD 2.1 format submissions have to include an additional file containing the more detailed submission classification information SAHPRA requires for the new streamlined review process. SAHPRA describes this xml format file as a \u2018Trigger\u2019 file.<\/p>\n\n\n\n
To facilitate this SAHPRA have published an Excel spreadsheet on their web site that allows users unfamiliar with the xml markup language to create the \u2018Trigger\u2019 file using Excel.<\/p>\n\n\n\n
In order to facilitate the production of the \u2018Trigger\u2019 file by any of its clients who may be challenged by this sophisticated spreadsheet, Quad Pharma has developed a simple app to create the Trigger file. It is called \u2018eQALs Trigger\u2019.<\/p>\n\n\n\n
\u2018eQALs Trigger\u2019 is easy to use and is fully documented with a comprehensive \u2018Help\u2019 function. It is easily installed on Windows PCs. It is also available free of charge to any pharmacists involved in medicines registration.<\/p>\n\n\n\n
To get your free personal copy simply email your request to robin@eqals.co.za<\/a> or info@quadpharma.com<\/a> .\u00a0 Do you need to \u2018Trigger\u2019 an eCTD solution? Helping finger is at hand! SAHPRA is in the process of streamline the review process for eCTD format regulatory dossier submissions. This involves an upgrade from eCTD version 2.1 to version 3.0<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-989","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"http:\/\/www.quadpharma.com\/qd\/wp-json\/wp\/v2\/pages\/989","targetHints":{"allow":["GET"]}}],"collection":[{"href":"http:\/\/www.quadpharma.com\/qd\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"http:\/\/www.quadpharma.com\/qd\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"http:\/\/www.quadpharma.com\/qd\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"http:\/\/www.quadpharma.com\/qd\/wp-json\/wp\/v2\/comments?post=989"}],"version-history":[{"count":3,"href":"http:\/\/www.quadpharma.com\/qd\/wp-json\/wp\/v2\/pages\/989\/revisions"}],"predecessor-version":[{"id":1000,"href":"http:\/\/www.quadpharma.com\/qd\/wp-json\/wp\/v2\/pages\/989\/revisions\/1000"}],"wp:attachment":[{"href":"http:\/\/www.quadpharma.com\/qd\/wp-json\/wp\/v2\/media?parent=989"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
You can also download <\/a>it from the Quad Pharma website.<\/p>\n","protected":false},"excerpt":{"rendered":"