Regulatory Requirements and Comparatiive Study Registration of Oral Rehydration Salt In Asean, African and CIS Region and Module 3 Preparation For ORS

Abstract

Thesis aim to provide a comparative study of Regulatory Requirement for submission of dossier and get a product registration certificate for ASEAN, CIS and African Region and their specific country like for ASEAN region Myanmar and Philippines, for CIS region Uzbekistan and Tajikistan and for African region Nigeria and Tanzania country study include and their global Pharmaceutical market of Oral Rehydration salt (ORS). In this research thesis include their regulatory process for product registration, which document is required for registration for product certificate and their fees and time of validity which is associated with Product. A comparative analysis table is developed which highlights their differences and similarities while registration of ORS in above mentioned countries. This table give an important information to manufacture company as well as suppliers of ORS gives and clear overview of their particular country specific regulatory landscape and expenses for registration of ORS product This thesis also provide a knowledge about the documentation of module 3 which include a quality part of ORS like using of drug substance and finished product manufacturing process, collection process, Analytical process and there reports, specification and there justification, container closers system, reference standard material, Stability data, control of excipients for ORS Product which help to pharmaceutical company to build a strong and high quality of module 3 and also help in understand of which kind of challenges face by ORS market stakeholder. This research help to give a short and how to apply for ORS product registration in above mention countries