ESG will introduce a web interface to submit and access tickets to all ESG users. This new web interface will allow ESG users to submit tickets, view ticket updates, view the history of all tickets (including closed tickets), and access FAQs based on the ticket Request Type. 1. ESG users may continue to send emails […]
New Guideline Data Requirements for Human Drug Submission updated on 24-October-2017 Version 2.1 for GCC CTD. The Saudi Food and Drug Authority (SFDA) has updated its Gulf Cooperation Council (GCC) data requirements for human drugs submission. The data requirements for each application will differ, depending on the drug submission type and all the required data […]
Generic drug user fee makes it possible for FDA and industry to ensure that the public has access to safe and high quality generic drugs and drug products. The implementation of the Generic Drug User Fee Amendments (GDUFA) encompasses a wide range of activities that fall within the scope of regulating the generic drug industry. […]
ESG upgraded its Pre-Production WebTrader application to 2.0 version, which is also known as Phase 2 release. Upcoming ESG 2.0 – Phase 2 Release
The EU Module 1 eCTD Specification has been subsequently updated from version 3.0.1 to version 3.0.2 respectively. The following aspects are addressed: 1. Due to an update of the EMA procedural guidance regarding documents displaying tracked changes in PDF format inside an eCTD sequence the following sentence was deleted: “An exception to this rule is […]
The MCC of South Africa has released updated versions of Module 1 eCTD specification and validation criteria (version 2.0 and 2.1 respectively).
eCTD is the standard format for submitting original applications, amendments, supplements, and registration changes to FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER).
As per guideline released on friday, FDA announces delay in submission of DMF in eCTD format until 5th may 2018
The new version of the Guideline on eSubmissions for Veterinary Products – version 2.4 together with eSubmission Validation checklist – version 2.4 and tools is published.The new VNeeS Guideline, checklist and checker will come into force on 01/07/2016.
New versions of the electronic Application Forms (eAF v. 01.19.0.1) are now available. The version v. 01.19.0.1 of the eAFs can be used from 30 November 2015 and will replace the current version of eAF v. 01.18 after a transitional period on 11 January 2016.