ANDAs that have one major deficiency will automatically be refused, while it takes 10 or more minor deficiencies to derail an application. If a sponsor decides to correct the deficiencies and resubmit the application, it will be considered a new ANDA and require a new GDUFA fee.
The European Medicines Agency (EMA) has launched user-acceptance testing of updated electronic application forms (eAF) for centralised procedures of initial marketing authorisations, variations and renewals for human and veterinary medicines. Companies are invited to take part in the exercise and provide feedback on user experience with the updated forms.
As a first milestone, the submission of new marketing authorization applications in the Decentralized Procedure must be done using the eCTD format from 1st of July 2015 onwards.
The Food and Drug Administration (FDA) is announcing the rates for abbreviated new drug applications (ANDAs), prior approval supplements to an approved ANDA (PASs), drug master files (DMFs), generic drug active pharmaceutical ingredient (API) facilities, and finished dosage form (FDF) facilities user fees related to the Generic Drug User Fee Program for fiscal year (FY) […]
See more at: http://www.raps.org/Regulatory-Focus/News/2015/05/14/22165/FDA-Releases-Guidance-for-Clinical-Trial-Sponsor-Investigators/?utm_source=social&utm_medium=post&utm_campaign=RFnews
From 1 November 2014 all submissions for Referral Procedures for human medicinal products should be sent via the eSubmission Gateway or the Web Client. After 1 November 2014, the EMA is no longer accepting electronic submissions for referrals on CD or DVD.
FDA to Require Electronic Submission of New Drug, Biologic Files in Next Two Years The US Food and Drug Administration (FDA) will require all new drug and biological product submissions to be sent electronically.
Annex I to the HMA eSubmission Roadmap on the implementation of eCTD version 4.0 and Annex II to the HMA eSubmission Roadmap on the implementation of mandatory eCTD format for regulatory submissions were adopted by the eSubmission Change Management Board (CMB) on 17th December 2014, and are now available here.
An electronic repository for periodic safety update reports (PSURs) and their assessment reports was launched by the European Medicines Agency (EMA). The central platform was created in accordance with the pharmacovigilance legislation of the European Union (EU) and will contain all information related to PSURs in the EU. It will facilitate the assessment of PSURs […]
Two Final Guidance for Electronic Submissions published by US FDA in December 2014 Providing Submissions in Electronic Format — Standardized Study Data https://lnkd.in/eUhwjj5