In previous posts, we have discussed what eCTD is and what an eCTD submission is. This post will look at electronic submission gateways and how they can be used to submit regulatory documents.
Electronic submission gateways have been implemented to streamline the electronic submission process and ensure an easy and secure transfer of information.
There are various eSubmission gateways in use, and they are:
● EMA eSubmission Gateway for Centralised Procedure submissions
● US FDA ESG for US FDA submissions
● FDA ESG for Health Canada submissions
● CESP for the EU
● MHRA Portal for MHRA submissions
● SMUH-ALTER for Portugal's INFARMED
There is not currently a gateway submission system in China. Still, the CDE (China Centre for Drug Evaluation) is prioritising developing an electronic submission system, so watch this space.
Let's take a closer look at each eSubmission gateway:
#EMA eSubmission Gateway for Centralised Procedure submissions
The EMA eSubmission gateway is related to the authorisation and maintenance of medicinal products and enables applicants to submit their eCTD format Centralised Procedure applications via a secure Internet connection.
#US FDA ESG for US FDA submissions
The Electronic Submissions Gateway (ESG) is the Food and Drug Administration (FDA) agency's solution for accepting electronic regulatory submissions. It enables the secure submission of premarket and post-market regulatory information for review.
#CESG for Health Canada
Health Canada uses the Common Electronic Submissions Gateway (CESG) to accept regulatory transactions for review in the electronic Common Technical Document (eCTD) format.
#CESP for the EU
The CESP (Common European Submission Platform) is an online delivery system capable of accepting information from stakeholders through one portal and then distributing this information to one or more agencies. It currently provides a delivery system for CAP/MRP/DCP /National submissions for human and veterinary products, clinical trial information and scientific establishments.
#MHRA Portal for MHRA submissions
The MHRA (Medicines and Healthcare Products Regulatory Agency) is responsible for registering medical devices in the UK. The MHRA portal allows registered users to submit:
● Wholesale Distribution Authorisation applications and variations
● Active Pharmaceutical Ingredient registrations, variations and annual reports for Manufacturers, Importers and Distributors of Active Substances
● Distance Selling Logo applications for companies whose site of economic activity is based in Northern Ireland and who sell human medicines online to the public.
#SMUH-ALTER for Portugal's INFARMED
The SMUH-ALTER portal is an online platform for submitting variation applications allowing applicants to submit applications and view information concerning applications submitted.
Although there are various eSubmission gateways, they all allow for a single-entry point for electronic submissions - receiving submissions, acknowledging receipt of submissions and directing them to the right place.
Submissions are a crucial part of any product life cycle, and eSubmissions make the process easier. If you are still unsure how to deal with eSubmissions, please get in touch with the experts at ONIX Life Sciences by phone on 01753 237 904 or email at info@onixls.com.