Abstract

The regulatory authorities in Indonesia and Vietnam and their procedures for registration of a drug are discussed in this document. The Indonesia and Vietnam comes under ASEAN countries. The drug medication is essential and important in ASEAN region. The process of manufacturing a drug will not vary but the regulatory authorities and requirements will differ. The regulatory authority of any country has to ensure the quality of the product and safety of the patients. As the regulatory requirements differ it will be challenging for the companies to produce drugs which are submitted for approval for various countries. The regulatory documents comparing Indonesia and Vietnam that should be submitted for the drug registration in the respective countries are enclosed in this article.

Keywords

ASEAN, Indonesia, Vietnam, Regulatory Authority

Cite This Article

Pidaparthi, P. (2016). Regulatory Requirements and Comparing Required Documents for the Drug Registration Process in Indonesia and Vietnam, International Journal for Pharmaceutical Research Scholars (IJPRS), 5(1), 162-167.