Abstract

COMPARISON OF ADMINISTRATIVE INFORMATION (MODULE 1) IN EAST AFRICAN COUNTRIES

P. Jaikumar*, K. Jaganathan, B. Senthilkumar and R. Vijayamirtharaj

Abstract

MODULE 1-ADMINISTRATIVE INFORMATION: The ICH Harmonised Tripartite Guideline on Organisation of the Common Technical Document indicates that the Common Technical Document (CTD) Module 1 should contain administrative documents specific to each region, for example, forms, labeling, etc., and that the format be specified by the relevant regulatory authorities. Module 1 summarizes information about regional administration, including a cover letter, a table of contents, an application form, information about the product, clinical and non-clinical data, pharmacovigilance work, a certificate and documents for the drug, including a GMP certificate, and a certificate of analysis of the drug substance with suitability, as well as patent information. This ASEAN Common Technical Dossier (ACTD) is a guideline of the agreed upon common format for the preparation of a well-structured Common Technical Dossier (CTD) applications that will be submitted to ASEAN regulatory authorities for the registration of pharmaceuticals for human use in the Association of South East Asian Nations (ASEAN) regions. The ACTD aims to facilitate the review process and reduce the workload of the regulatory authorities and the applicants. The contents of the dossier modules (Module 1 – 5), Comparison for the administrative information (Module 1) differentiation in East African Countries. (Eritrea, Ethiopia, Uganda, Tanzania, and Kenya) and Manufacturing and marketing authorization & Registration status.

Keywords: Module-1, CTD, ACTD, ASEAN, ICH, EMA.