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.
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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
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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.”
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South Africa: MCC releases updated Module 1 eCTD specification and validation criteria

The MCC of South Africa has released updated versions of Module 1 eCTD specification and validation criteria (version 2.0 and 2.1 respectively).
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FDA’s Requirements for eCTD Submissions

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).
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