The process of dossier submission

We all know publishing is the last step before sending the sequence to the applicable authorities. Thus, once a dossier is published and validated by our team at PLG, we also assist our clients in submitting this sequence to the authorities. Depending on the region you have published for, our publishers may be able to submit from anywhere in the world without needing a local representative. Regions where our publishers can assist clients in submission to authorities are the United States, Canada, the UK, and the European Union countries. Let us look at the particularities of these regions in terms of submission.


Dossier submissions in different regions

  • The United States Food and Drug Administration (FDA) Electronic Submissions Gateway (ESG) is an Agency-wide solution for accepting electronic regulatory submissions. The ESG enables the secure submission of premarket and postmarket regulatory information for review. It is the central transmission point for sending information electronically to the FDA. ESG is a channel where submissions travel to reach the proper FDA Center or Office. The electronic submission process encompasses the receipt, acknowledgment of receipt (to the sender), routing, and notification (to a receiving Center or Office) of the delivery of an electronic submission. FDA ESG provides WebTrader (WT) and AS2 methods for submitting to FDA. WT: A web portal designed for low-volume submitters. WT allows users to log in, digitally sign submissions, and view responses through a simple web interface. AS2: A system-to-system connection to exchange submissions with the FDA. AS2 requires a Gateway software implementation on the submitters’ end.
  • Health Canada is collaborating with the FDA and uses the same gateway. The Common Electronic Submissions Gateway (CESG), called in Canada, securely provides regulatory transactions for review in the electronic Common Technical Document (eCTD) format to Health Canada. The same two methods, WebTrader (WT and AS2, can also be used for making submissions to Health Canada.
  • In preparation for Brexit, the United Kingdom’s Medicines & Healthcare products Regulatory Agency (MHRA) has developed a national portal where all applications are submitted for the UK or GB market. Submissions related to human medicines for the UK and GB need to be submitted directly to the MHRA. For those regulatory submissions made through European procedures to market in Northern Ireland, you must submit via the appropriate EU systems.
  • In Europe, two separate gateways can be used to submit to authorities.
  • The first is for Centralized Procedures (CPs) and PSUSA/PBRER EMA eSubmission Gateway/Web Client has been mandatory for all submissions for human medicinal products made through the Centralised Procedure since March 2014 and for veterinary products since January 2017. In addition, all PSUSA/PBRER submissions are made through this EMA eSubmission Gateway and have been mandatory since June 2016. The eSubmission Gateway and the eSubmission Gateway Web Client are electronic submission channels that allow submitting documents supporting all types of applications related to authorizing and maintaining medicinal products to the EMA securely over the internet in structured and non-structured formats. They are based on the ESTRI (Electronic Standards for the Transfer of Regulatory Information) gateway standard, which defines a secure data exchange service for regulatory information. The web-based Gateway Web Client, available for all applicants, may be particularly relevant for Small and Medium-sized Enterprises (SMEs) and companies with lower IT budgets and submission volumes. The Gateway and the Web Client provide an automated confirmation of the technical validation feedback and an automated upload to the EMA’s eCTD review system. The eSubmission Gateway and the Web Client are mandatory for all submissions.
  • The second one was developed by the HMA network (a collaboration between Heads of Medicines Agencies in all member states) mainly for National Procedures (NPs), Mutual Recognition Procedures (MRPs), and Decentralized Procedures (DCPs). The Common European Submission Portal (CESP) is an online delivery system that provides a simple and secure mechanism for exchanging information between stakeholders and agencies. It allows submitting an application through one portal and distributing it to one or more agencies simultaneously.


How PLG can support your dossier submissions

Being able to submit sequences to authorities via all these channels without receiving invalidation requires expertise and constant training to stay knowledgeable and compliant. Another factor is the licenses needed, which can be time-consuming to obtain and maintain and associated with a direct or indirect fee. At PLG, our publishing team removes this burden from the client and offers to submit to authorities on their behalf electronically. PLG’s Regulatory Affairs (RA) team can support the submission of the sequence to the remaining regions not supported by the publishing team.

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Dossier Submission to Health Authorities (ESG, CESG, CESP, EMA Gateway, MHRA)