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
Romania will join the Common Repository to receive Centralised Procedure submissions from 1st January 2015. The majority of the NCAs are now using the Common Repository as their only source to receive Centralised Procedure eCTD submissions. In compliance with the HMA eSubmission Roadmap, it will be mandatory for all NCAs to use the Common Repository […]
Following is the list of recent EMA”s updates with links to updated documents/guidelines:
US Food and Drug Administration (FDA) has proposed a new rule requiring biopharmaceutical companies to distribute product labeling information to healthcare providers electronically.
The specification for the Australian electronic Common Technical Document (eCTD) format submissions.
From 1 July 2015, new market authorisation applications for decentralised procedures must be submitted in electronic common technical document (eCTD) format.
Prescription medicine sponsors can now submit dossiers to the TGA (Therapeutic Goods Administration) in the electronic Common Technical Document (eCTD) format. Paper dossiers are no longer required to accompany eCTD formatted submissions, following the success of the pilot programme between January and June 2015. Paper dossiers are also not required to accompany Non-eCTD electronic Submissions […]