The Common Technical Document (CTD) is a worldwide standard for the preparation of regulatory submissions for new pharmaceuticals. It provides a unifying structure for scientific and administrative information required by regulatory officials in various countries when evaluating marketing authorization applications for new drugs. The CTD format was first developed in 1997 and has since been updated on numerous occasions.
It is now in its fifth revision (CTD5), which was published in December 2016. The CTD is divided into five modules:
1) Administrative information and declarations
2) Clinical summary
3) Nonclinical summary
4) Quality summary
Each module is further divided into a number of sections.
The sections in each module are designed to provide the information required by the relevant regulatory authority in a standardized format. This makes it easier for authorities to review submissions and compare different submissions for the same product. It also makes it easier for companies to prepare submissions, as they can use the same format for submissions to different authorities.
The CTD is not a regulatory requirement, but it is widely used by pharmaceutical companies and regulatory authorities around the world. In Europe, the use of the CTD format is mandated by the European Medicines Agency (EMA) for initial marketing authorization applications for human medicines.
What are the benefits of using the CTD format?
The CTD format provides a number of benefits for both regulatory authorities and pharmaceutical companies:
1. It makes it easier for regulatory authorities to review submissions and compare different submissions for the same product.
2. It makes it easier for companies to prepare submissions, as they can use the same format for submissions to different authorities.
3. It helps to ensure that submissions contain all of the information required by the relevant regulatory authority.
4. It provides a standardized format for the presentation of scientific and administrative information in marketing authorization applications.
5. It makes it easier to identify gaps in submissions and to request additional information from applicants, if necessary