A Comparative Overview of Generic Drug Regulation in US, Europe, Australia and India

Abstract

This study aims to examine the registration procedures for generic drugs in the United States, India, Australia, and the Europe concerning regulatory submissions. The information and data were gathered from relevant publications and the official websites of the respective drug regulatory agencies: the U.S. Food and Drug Administration (USFDA) for the United States, the Central Drugs Standard Control Organization (CDSCO) and Drug Controller General of India (DCGI) for India, the Therapeutic Goods Administration (TGA) for Australia, and the Medicines and Healthcare products Regulatory Agency (MHRA) for the Europe. Our comparative analysis reveals significant differences in the criteria and processes for generic drug approval among these countries. In the United States, the Abbreviated New Drug Application (ANDA) process through the FDA typically takes about six months. In India, regulatory approval from CDSCO/DCGI is generally faster, with an approval timeline of approximately 90 days. In Australia, the TGA oversees generic drug approvals, which take about 11 months, making it a notably slower process compared to the U.S. and India. In the Europe, the MHRA is responsible for regulating generic drugs, with an approval timeline of approximately 150 days under the national procedure or European procedures when applicable.

This review provides a detailed comparison of the generic drug approval processes in these countries, highlighting key variations in regulatory requirements and approval timelines. Understanding these differences is essential for pharmaceutical companies seeking market entry and regulatory compliance across multiple regions.