Compendium of Medicines Evaluation and Registration for Medicine Regulation Harmonization in The East African Community

This guideline provides guidance for applicants preparing a Common Technical Document for the Registration of Medicines for Human Use (CTD) for submission to the EAC-NMRA. The document describes how to organize applications based on the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines on the CTD.

According to the CTD format, each application is a collection of documents, grouped into 5 modules. Module 1 prescribes Administrative Information and Prescribing Information requirements, which is region specific. The Summaries, Quality, Non-clinical, and Clinical modules have been described in Modules 2 to 5, respectively. Applicants should not modify the overall organization of the CTD.

If not contained in the bulk of the documentation, any additional data should be included as addenda to the relevant part, together with additional expert comment that may be provided as a supplement to,
or incorporated into, the relevant summary, overall summary or overview.

Information in these Modules should be present in relevant sections.

For application procedures refer EAC Guidelines on Procedural Aspects for Application for Market Authorization for Human Medicinal Products. (EAC/TF-MED/MER/FD/ GDL/N14R0)