CTD – eCTD from Specialists
The International Standard for Submissions of Medicinal Products, the CTD, has introduced a data format for the harmonization of drug regulatory conditions in the European Union, the United States and Japan as part of the International Conference on the Harmonization of Technical Requirements for the Registration of Human Medicinal Products (ICH). Harmonization will make it possible to submit identical registration documents in different countries for a new medicinal product.
The regulatory requirements for the documentation of a drug have steadily increased due to constant progress and new findings. As a result, the volume of data and the complexity of registration dossiers also increased, making it increasingly difficult to process applications in paper form.
To make these data volumes clearer for applicants and authorities, an electronic format, the eCTD (electronic Common Technical Document), was developed. The content of the eCTD is based on the structure of the CTD format (ICH M4 – The Common Technical Document) and consists of 5 modules. Module 1 is region specific and Modules 2, 3, 4 and 5 are intended to be common for all regions. In July 2003, the CTD became the mandatory format for new drug applications in the EU and Japan, and the strongly recommended format of choice for NDAs submitted to the FDA, US.
Module 1 Administrative and national information as well as the product information
Module 2 Overview documents / summaries of modules 3, 4 and 5
Module 3 Production and Quality Data
Module 4 Preclinical Data (Research Reports, Studies and Literature)
Module 5 Clinical Data (Research Reports, Studies and Literature)
Via a linked table of contents, you can now easily navigate between the modules up to the individual documents. With the help of special software for eCTD, metadata (XML format) are created automatically in the background, which support Lifecycle Management and enable the generation of consolidated dossier statuses at any time with just a few clicks.
CTD – eCTD done right
Create - Convert - Compile - Validate – Maintain
orangeglobal will take over the eCTD creation and maintenance (lifecycle management) of existing drug dossiers. In addition, we offer the creation or reformatting of your dossiers from previous formats into the CTD format.
Our process for the preparation of registration dossiers, which pass the initial validation to the competent authorities without any problems, includes:
- Recording your volume of approval applications
- Analysis of existing dossiers (paper or electronic dossiers, NTA format and older, non-European formats, NeeS and eCTD)
- Development of technical solution proposals (creation, updating / maintenance, reformatting)
- Build a project team and identify roles and responsibilities
- Preparation of the dossier with modules 1 to 5 (for example EU-CTD):
- Applications, documents, product information, readability tests, etc.
- Module 2: summaries and overviews of modules 3, 4 and 5
- Module 3: Quality and Manufacture - Chemical, Pharmaceutical and Biological Medicines
- Module 4: Preclinical documentation
- Module 5: Clinical Documentation
- Translation of all or selected dossier chapters through our translation and language management in all desired target languages
- Reformatting of existing dossiers to the current formats., E. eCTD, NeeS or paper dossiers, etc. considering all authority requirements and validation criteria
- Government communication throughout the process
We are happy to send you a detailed quote based on the provided dossier information of your drug product(s) and your objectives.
Please, feel free to contact:
Frau Dipl. Biol. Jana Wolkow
Project Manager Regulatory Affairs
Tel. +49 (0) 731 954 95 - 511
jana.wolkow@orangeglobal.(.)de