2022 Volume 71 Issue 2 Pages 115-128
In 2014, the Pharmaceutical Affairs Law changed its name to the “Act on Securing Quality, Effectiveness, and Safety of Pharmaceuticals and Medical Devices” (commonly known as the Pharmaceuticals and Medical Devices Act, Pharmaceutical Machinery Act). The latest major revisions were made at the end of 2019.
GMP surveys of pharmaceutical products can also be conducted on a factory-by-manufacturing basis. However, it is necessary to establish a legal compliance system for pharmaceutical products manufacturers. The GMP Ministerial Ordinance was amended in 2021 to align with international standards.
In April 2020, Kyoto Prefecture launched the "Kyoto Prefectural Pharmaceutical Affairs Support Center" to support manufacturers.
In this article, I will introduce the contents of the revised Pharmaceutical Machinery Law, the outline of the Pharmaceutical Machinery Law system, and the efforts of the Kyoto Prefectural Pharmaceutical Affairs Support Center.
