Borui Medicine passed the Japanese PMDA official certification
(Summary description)On February 6, 2017, Xintai Pharmaceutical (Suzhou) Co., Ltd. and Borui Biomedical Taixing City Co., Ltd., two wholly-owned subsidiaries of Borui Biomedical (Suzhou) Co., Ltd., both successfully passed the Japanese GMP inspection of PMDA. . This result not only shows that Borui has mastered the operation procedures of MF declaration and data maintenance, but also marks that Borui's GMP level has reached the official requirements of Japan, which is well-known for its strict supervision, and has laid a solid foundation for Borui to enter the Japanese market. This is another step in the development of the international market after Borui Pharmaceutical successfully passed the official GMP certification in Europe and the United States.
On February 6, 2017, Xintai Pharmaceutical (Suzhou) Co., Ltd. and Borui Biomedical Taixing City Co., Ltd., two wholly-owned subsidiaries of Borui Biomedical (Suzhou) Co., Ltd., both successfully passed the Japanese GMP inspection of PMDA. . This result not only shows that Borui has mastered the operation procedures of MF declaration and data maintenance, but also marks that Borui's GMP level has reached the official requirements of Japan, which is well-known for its strict supervision, and has laid a solid foundation for Borui to enter the Japanese market. This is another important milestone for Borui Pharmaceuticals in exploring the international market after successfully passing the official GMP certification in Europe and the United States.
[PMDA] (Pharmaceuticals and Medical Devices Agency) is the official regulatory agency for Japanese medicines. Its main responsibility is to ensure the quality, safety and effectiveness of pharmaceutical products and medical devices. PMDA is responsible for both the review of the submitted drug master file (MF) and the implementation of GMP inspections of domestic and foreign pharmaceutical manufacturing companies. The two are organically related. A drug must be approved by the PMDA through the technical review of MF and the GMP inspection at the production site. The industry generally believes that PMDA supervision is the most stringent and meticulous in the world, and carelessness in any details will lead to stranded MF reviews or failed GMP inspections, affecting the time to market for drugs.
Japan, which ranks among the top 10 in the world by population density, is the third largest drug market country in the world, is one of the three core members of the ICH (the other two members are the United States and the European Union), and is a member of the PIC / S organization.
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