The Japanese drug master file

Abstract

Pharmaceutical market in Japan is the largest in Asia by value. ICH comprises three developed regions namely USA, Europe, and Japan. Though majority of regulations are harmonized, Japan’s regulations are yet less explored compared to USA and Europe perhaps due to language barriers. Sharing of vital technological information to the drug product manufacturer remains a cause of concern to the manufacturers of ingredients and packaging components. Master files are voluntary vehicles for conveying product and manufacturing information from suppliers and contractors directly to regulators to support new drug and biologic product review, and may have open and closed sections. The latter contains confidential information for regulator’s reference. Japan has master file systems that accommodate a broader range of drug and components like packaging materials. Japan added a master file system similar to the US model by updating its regulatory process under the 2005 Pharmaceutical Affairs Law. The accreditation of manufacturing facility is one of the very unique features of master file system as unlike US and Europe, for Japan facility approval process starts well before the submission of the actual drug master file. The stability requirements involve more sample analysis compared to the other international regulatory compliance requirements. Point has to be noted that data equivalent to module 2 of common technical document and application form are required to be translated in Japanese language. However, the quality section (module 3) can be submitted in English language. Understanding of master file system is important for companies entering into the Japanese market. The master file system of Japan is discussed in this article.