Abstract

REGULATORY REQUIREMENTS FOR GENERIC DRUG PRODUCT IN JAPAN

R.Suthakaran

ABSTRACT

Today, the generic drug industry is driven by many stakeholders. Consumers demanding low-cost alternatives to expensive brand-name products are at the forefront. Generic drug development is also leading the way in encouraging healthy competition and ensuring the safety and efficacy of generic drug products. Additionally, the professional services of medicine and pharmacy, despite having a somewhat conflicting relationship in the past, now jointly advocate the development of low-cost alternatives to serve the needs of their patients. There should be a customized plan and approach to meet the complex regulatory requirements of Japan. The strategy is characterized by attention to detail in their preparation of the regulatory documents, while considering in guidelines of PMDA and in reference to the ICCT. This study will be helpful for the accelerated understanding of the approval process of generic drug product.

Keywords: Regulatory requirements, drug approval, ICCT, PMDA.