Documents

eCTD (electronic Common Technical Document) is a standard format of submitting documents of medicinal product’s dossier to Health Authorities (e.g., for Marketing Authorization). Submission of an electronic documentation (eCTD) is used in most European countries, even worldwide.

The eCTD electronic documentation has XML support that allows tracking lifecycle of dossier evaluation and approval. The eCTD consists of a folder structure, XML backbone and records. Sequence creation, review, lifecycle management and archival of electronic submissions is much easier with eCTD.

Benefits of eCTD: 

  • Improved handling and archiving of submissions
  • Improved Life cycle management 
  • Reviewers are familiar with the content and document standards
  • Facilitated search and immediate access to updated documents 
  • Documents are easily accessible
  • Simplified business process
  • Better communication with the industry and external experts
  • No need to store, copy or scan paper documents

With eCTD it is much easier and efficient communication between the applicant and the National Competent Authorities. In other countries where still eCTD electronic documentation is not obligatory companies submit dossiers in hard way, e.g., hard submission. Medisint can support you with switching from paper documentation or NeeS format to eCTD format. Marketing authorization holders are encouraged to use eCTD documentation.

eCTD

eCTD contains 5 modules:

  • Module 1 contains regional administrative information specific to the region to which the dossier is being submitted. 
  • Module 2 contains summaries and overviews of the three CTD technical sections: Quality, Safety and Efficacy. 
  • Module 3 contains information of quality of the pharmaceutical substance and product. 
  • Module 4 contains information on the non-clinical (pharmacological, pharmacokinetic and toxicological) evaluation of the substance and product. This information is typically provided in the form of study reports and publications.
  • Module 5 contains information on the clinical evaluation of the medicinal product. This module typically includes Clinical Study Reports describing each conducted clinical study. Supportive publications are also provided here.

With eCTD all regulatory activities can be managed. Marketing authorizations, variations, renewals, marketing authorization transfers can be managed threw eCTD. To stay ahead, companies are required to stay up-to-date with the eCTD requirements.

How can Medisint support medicinal product dossier lifecycle management?

Medisint provides services of maintenance lifecycle of your medicinal product including:

  • dossier review 
  • transfer dossier to eCTD format
  • compilation eCTD sequence for national, mutual recognition and decentralised procedures
  • advise for country specific documents
  • eCTD sequence validation and quality control
  • CESP submission to the National Competent Authorities

Our main goal at Medisint it to provide you with valid and reliable services for all your regulatory needs. In this way we can help you make better, more informed decisions and improve your position on EU market. If you have any question or would like to use any of our services feel free to contact us.