Filing Basics - The eCTD

Question 1

What is a filing?

Answer 1

A Filing refers the dossier that a company submits to health authorities to seek approval of a new pharmaceutical medicinal product, a new indication for an already marketed product, or a new formulation.

Question 2

Outline the difference between NDA’s and BLA’s.

Answer 2

In the US, filings are referred to as New Drug Applications (NDAs) for small molecules, Biological License Applications (BLAs) for biologicals or supplemental NDA (sNDA) or supplemental BLA (sBLA); In the EU, filings are called Marketing Authorization Applications, Type II variation and so on.

Question 3

What does Module 4 of the eCTD contain?

Answer 3

Module 4 contains the non-clinical study reports on pharmacology and toxicology.

Question 4

List three examples of other documents that have to be prepared before or in parallel to the submission dossier.

Answer 4

-orphan drug applications, -breakthrough designation -briefing packages

Question 5

What templates do you need to use when writing documents for a filing?

Answer 5

All documents are written using Global Document (GD) Templates. Tip: Make sure to have them installed on your computer.