A Review Process of ANDA Filling in PMDA (Japan) and Calibration of UV in Accordance to its Regulatory Guidelines

Abstract

The Abbreviated New Drug Application (ANDA) filing system is an important regulatory process in Japan for the approval of generic drugs. This system allows pharmaceutical companies to submit an application for the marketing and sale of a generic drug, which has already been approved by the regulatory agency in another country. The ANDA system in Japan is similar to that of the United States and Europe, but there are some unique aspects that must be taken into account. For example, in Japan, the regulatory agency requires a separate drug master file for each active pharmaceutical ingredient, which can be a time-consuming process. UV spectrophotometry is a widely used analytical technique for the characterization of pharmaceuticals, including active pharmaceutical ingredients and finished dosage forms. The Shimadzu UV-1800 spectrophotometer is a popular instrument for this purpose, which is widely used in Japan. This instrument has a range of features that make it particularly useful for pharmaceutical analysis, including a wavelength range of 190-1100 nm, a double beam optical system, and a low stray light level. The Shimadzu UV 1800 is also compatible with a range of accessories, such as a multicell holder, which allows for the simultaneous measurement of multiple samples. The combination of the ANDA filing system and UV spectrophotometry using the Shimadzu UV-1800 is an important tool for the development and approval of generic drugs in Japan. The ANDA system allows for a streamlined regulatory process for generic drug approval, while UV spectrophotometry provides a reliable and accurate method for the characterization of pharmaceuticals. Together, these tools help to ensure the safety and efficacy of generic drugs in Japan.