+91-62 89 87 84 25
info@royed.in

@Royed Updates

Clarification, News & Notifications
4 Dec 2023

What is meaning of Common Technical Document (CTD)?

/
Posted By
/
Comments0
/
Tags

The Common Technical Document (CTD) is a set of specification for application dossier for the registration of Medicines. And it is designed to be used across Europe, Japan and the United States. It was developed by the European Medicines Agency (EMA,Europe), the Food and Drug Administration (FDA, U.S.) and the Ministry of Health, Labour and Welfare (Japan). The CTD is maintained by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).
The agreement to assemble all the Quality, Safety and Efficacy information in a common format called CTD – Common Technical Document,  has revolutionised the regulatory review processes, led to harmonised electronic submission that, in turn, enabled implementation of good review practices. For industries, it has eliminated the need to reformat the information for submission to the different ICH regulatory authorities.

The CTD provides a common format for the submission of information to regulatory authorities in different regions, streamlining the process of regulatory approval for pharmaceutical products. It is divided into five modules:

  1. Module 1: Administrative information and prescribing information.
  2. Module 2: Summaries of quality, safety, and efficacy.
  3. Module 3: Quality (Chemical and Pharmaceutical Documentation).
  4. Module 4: Nonclinical Study Reports.
  5. Module 5: Clinical Study Reports.

By adopting the CTD format, pharmaceutical companies can submit a consistent set of documents to regulatory authorities worldwide, facilitating the review process and promoting harmonization in drug regulatory requirements across different regions. This helps streamline the drug approval process and ensures that regulatory authorities have access to comprehensive and standardized information when evaluating the safety, efficacy, and quality of pharmaceutical products.

Leave a Reply

Scale up your knowledge to Next Level with our Free Content

Case studies & Caselets |Simulation based learning | Online self competency assessment tests 

Thank You for Subscription!