What is an eSubmission?

The eSubmission Gateway and the eSubmission Gateway Web Client are electronic submission channels that allow the applicants to submit documents supporting all types of applications for human and veterinary medicines to the Agency securely over the internet in structured and non-structured formats.

What is eCTD EMA?

A common technical document in electronic format.

What is electronic application form?

The electronic application forms allow pharmaceutical companies to apply for initial marketing authorisations, variations or renewals for human and veterinary medicines using interactive PDF forms.

How do I submit to PSUR?

PSUR submissions to the Repository are made using the eSubmission Gateway/Web Client with the use of an XML delivery file. The delivery files are used to provide required metadata allowing the EMA to process the submissions. You can find the link to the tool to create the delivery file here.

How do I submit to the FDA?

FDA’s preferred method of submission is via the FDA Electronic Submissions Gateway (ESG). For more information, see the Electronic Submissions Gateway web page. For automated processing of your submissions, use the ESG and submit an FDA fillable form with each submission.

What are FDA files used for?

Drug master files (DMFs) are submissions to FDA used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products. They: Allow parties to reference material without disclosing DMF contents to those parties.

What countries use eCTD?

Currently, the following countries accept eCTD submissions: the US, EU, Canada, Gulf Cooperation Council (Saudi Arabia, Oman, UAE, Bahrain), Jordan, Australia, Switzerland, South Africa, Thailand, and Japan.

What is eCTD software?

The eCTD software provides submission-related document templates, as well as preconfigured document types specific to a company’s submission. Collaboration functionality and MS-Word integration enable cross functional teams to collaborate on submissions documents, while ensuring their reliability and security.

How do you make an application form?


  1. Be Prepared. Make sure you know the correct names, dates, places and other information you will need.
  2. Ask If You May Take A Blank Application Home.
  3. Read The Form.
  4. Be Neat.
  5. Answer All Questions Completely And Correctly.
  6. Be Positive.
  7. Be Clear.
  8. Alert References Beforehand.

What is PSUR PPT?

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What is FDA send?

What is SEND? CDISC SEND is the Clinical Data Interchange Standards Consortium Standard for Exchange of Nonclinical Data, an FDA standard data format/terminology that is now required for submission of preclinical study data to the FDA.

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