Survey the drug registration process of distribution companies in Ho Chi Minh City

Abstract

    The research focuses on the drug registration in Vietnam. Overall, drug registration regulations have been gradually improved over the years. The dossier for registration of drugs in Vietnam shall comply with ASEAN's general ACTD dossiers. This document is organized into four parts: Administrative Data and Product Information, Quality Document, Nonclinical Document, Clinical Document. The first part varies from country to country, but the rest are the same in Southeast Asia. Through the process of surveying drug registration status in 2018 of distribution companies in Ho Chi Minh City, companies have observed very strict regulations from the Ministry of Health. So the quality of drugs in the pharmaceutical market is guaranteed. However, complicated dossiers and the time to issue registration numbers have had a considerable influence on the distribution activities of the companies.