Journal Article

Regulatory Requirement and Registration Process of Generic Drugs in Japan

Kamaraj, R., Poovarasan, D, Manikandan, K.

2020

Overview

Regulatory professionals are employed in academia and government andindustry are involved with a wide range of products, following;medical device, Pharmaceuticals, in vitro diagnostics, cosmetics, nutritional product, biologics and biotechnology, veterinary product. \"The Japanese reimbursement system is streamlined compared to the complicated processes companies need to go through in other countries, with pharmaco-economics rarely used to make listing decisions. [...]Japan has a much lower penetration of generics compared to most of the major markets which is advantageous for the big Pharma\". Japanese Regulatory Authority: PMDA is a regulatory authority of Japan.PMDA continues to improve the safety and public health of nation by reviewing applications for marketing approval of pharmaceuticals and conducting safety measures, medical devices, and providing relief to people who have endure from adverse drug reactions. Steps involved in Registration for Generic drugs in Japan: Foreign Manufacturer Accreditation: A person or company who is calculating to quasi-drugs, manufacture drugs, or medical devices in foreign countries and export those drugs to Japan, where those authorization done by the Minister of Health, and Welfare, Labor as an \"Accredited Foreign Manufacturer\", mentioned in Article 13-3 of PAL, (Pharmaceutical Affairs Law) in the each way that a Japanese manufacturer is licensed.

• Publisher: A&V Publications
• Subject: Accreditation / Generic drugs / Generic products / Marketing / Medical equipment