Which organization developed the CTD framework?

The Common Technical Document (CTD) framework was developed by the International Conference of Harmonization (ICH). The ICH is a cooperative initiative between the regulatory authorities and pharmaceutical industry associations of the European Union, Japan, and the United States aimed at harmonizing regulatory requirements for the registration of medicines. The CTD provides a structure for the submission of applications for the registration of pharmaceuticals, promoting efficiency and standardization across regions.

This framework consists of five modules that cover various aspects of drug development, safety, efficacy, and quality. By establishing this standardized document format, the ICH facilitates the process of drug approval across different countries, streamlining submissions for manufacturers and improving regulatory consistency.

Organizations like the FDA and EMA utilize the CTD framework in their own regulatory processes, but they did not create it. The World Health Organization (WHO) has its own sets of guidelines and recommendations for drug regulation, which may influence practices globally, yet it is not responsible for the development of the CTD. Understanding the role and contributions of different organizations in drug regulation is critical for navigating the regulatory landscape effectively.