Introduction to US Entry Biomaterials Regulatory Framework and Some Considerations for China Entry Biomaterials Regulatory WorkFu-liyuan1 Lu-yan 2 Ma-feng1 Zhang-jun1 Liu-xiangli3 Chang-jianjie3 Ye-jia3
Author:
Affiliation:
1.Suzhou entry-exit inspection and quarantine bureau;2.Jiangsu entry-exit inspection and quarantine bureau;3.WuXi AppTec(Shanghai) Co.,Ltd,
S : [Objective] The paper discusses the focus and difficulty of entry biomaterials regulatory in China refer to US entry biomaterials regulatory framework and. [Method] The content and procedures of entry biomaterials regulatory of CBP FDA CDC USD of USA were searched and induced.[Conclusion] The paper discusses from four aspects: (1) Import and export of biopharmaceutical enterprises have the obligation of integrity management. (2) Import and export of biopharmaceutical enterprises must be primarily responsible for biosecurity management. (3) We must attach importance to input of basic research of entry biomaterials supervision required. (4) We must attach importance to improving authority and operability of relevant domestic laws of import and export special goods through learning and the introduction of international regulations and mature technology.
