Regulatory submissions in eCTD format
– a challenge for many companies
By Susanne Felumb
Paper-free submissions are actually good news. Switching from paper to eCTD format will be an advantage for your company when it comes to keeping track of submitted regulatory documents.
Regulatory submissions in eCTD format is now mandatory for all new marketing authorisations (MAAs) – including national procedures.
Next step: From 1 January 2019, the eCTD requirement for all submission types such as variations and renewals will also be implemented for nationally approved human medicinal products.
This means that NeeS and paper-based applications will be phased out, and all applications must be in eCTD format.
Let us help you prepare your eCTD submissions
The Danish Medicines Agency is close to implementing eCTD as the only acceptable format for all types of submissions and encourages all applicants to switch to eCTD format for National Procedures as soon as possible. It should be noted that submission of a baseline is not mandatory.
We can help you with your eCTD submissions
For an initial talk, please contact Susanne Felumb.
For an initial talk, please feel free to contact Susanne directly at: +45 4450 3206, or via
Susanne FelumbCEO and QA Manager, MSc. Pharm.
Susanne is the owner and CEO of PharmAdvice, and has more than 20 years of experience in the international pharmaceutical industry with QA, and regulatory affairs.