Sichuan Deebio Pharmaceutical Co., Ltd. (hereinafter referred to as Deebio) underwent an official GMP compliance inspection from PMDA in Japan from August 25th to August 26th, 2022. The GMP audit team was composed of two auditors led by experienced experts and conducted a two-day remote audit. The inspection team experts conducted a thorough inspection of Deebio’s quality management system, production management system, on-site operation, laboratory management, as well as related supporting facilities and equipment, and maintenance of public systems. Through inspection, the expert members of the inspection team unanimously affirmed and highly recognized Deebio’s GMP quality management system. With the joint efforts of all employees of the company, Deebio successfully passed the official GMP certification of Japan PMDA!

About Japan PMDA

PMDA (Pharmaceuticals and Medical Devices Agency), also known as the “Independent Administrative Legal Person Pharmaceutical and Medical Device Comprehensive Institution”, is a Japanese agency responsible for the technical evaluation of drugs and medical devices. It is functionally similar to the FDA in the United States and the NMPA in China, so it is also commonly known as the “Japan Drug Administration”.

The main responsibility is to ensure the quality, safety, and effectiveness of pharmaceutical products and medical devices. PMDA is responsible for both reviewing the submitted Drug Master File (MF) and conducting GMP inspections on domestic and foreign drug manufacturers in Japan, both of which are organically linked.

The drug must first pass the technical review of MF and pass the GMP inspection of the production site before obtaining PMDA approval. Industry insiders generally believe that the regulation of PMDA is the strictest and most meticulous in the world, and any carelessness in details will lead to the stalling of MF’s review or the failure of GMP inspections, affecting the time to market of drugs.

Japan, which ranks among the top 10 in terms of population density in the world, is the third largest drug market country and one of the three core members of ICH (the other two members are the United States and the European Union). It is also a member of the PIC/S organization.