Electronic Submissions Gateway-New Ticketing Interface

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 to esghelpdesk@fda.hhs.gov to create tickets and receive response from ESG Help Desk.
2. ESG users may also submit tickets directly to the FDA via https://esghelpdesk.fda.gov.
3. Sending an email to esghelpdesk@fda.hhs.gov automatically creates a new account for each “from” email address. If you have previously communicated with esghelpdesk@fda.hhs.gov then your account already exists in the system and you do not need to send another email to create account.]

For further information please refer:
https://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/default.htm

Data Requirements for Human Drug Submission updated version 2.1 for GCC CTD

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 should be in accordance with the CTD structure.

https://www.sfda.gov.sa/en/drug/drug_reg/Pages/default.aspx

Generic Drug User Fee (GDUFA): Proposed Changes for 2018

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. Generic drug user fee act was reauthorized on August 18, 2017 (GDUFA II), with provisions that go into effect from October 1, 2017 and remain in effect through September 30, 2022.
(more…)

ESG upgraded its Pre-Production WebTrader application

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
(more…)

EU Module 1 eCTD Specification

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 in the provision of either product labelling or risk management plan documentation in the Centralised Procedure, where the tracked changes version of the document in PDF format should be placed inside the eCTD, alongside the clean, non‐tracked version.”
(more…)