E-submission gateway mandatory for centralized eCTD filings
This article was originally published in SRA
Executive Summary
From 1 March, companies in the EU will no longer be able to make centralised electronic common technical document (eCTD) product filings using CDs or DVDs. Instead, all such filings, including active substance master file submissions, must be made via the eSubmission Gateway or web client1.
You may also be interested in...
Industry & Regulators To Align Advice on COVID-19 Vaccine Updates
A multi-stakeholder workshop looked at the data needed to support updates to vaccine composition and the time required by manufacturers to update their vaccines, change their manufacturing processes and prepare approval applications.
Denmark Planning To Impose Drug Stockpiling Obligations From July
A new bill is intended to address the increase in medicine supply problems in Denmark in recent years.
National Drug Stockpiles Create ‘False Sense Of Security’
The generics and biosimilars industry body Medicines for Europe says disparate national stockpiling requirements are not a solution to shortages and can bring “significant risks” for the supply chain and access to medicines.