"Administrative Measures for the Issuance of Biological Products" will be implemented on February 1

Recently, the State Food and Drug Administration issued the revised “Administrative Measures for the Issuance of Biological Products” (hereinafter referred to as the “Measures”), which will take effect on February 1, 2018.

 

The "Measures" strengthen the main responsibility of enterprises, clarify that the applicants for the issuance of imported biological products are overseas pharmaceutical enterprises, and stipulate that overseas pharmaceutical enterprises should authorize their domestic offices in China or domestic corporate legal persons to act as agents to issue approvals, and clearly identify the applicants. The quality of the batch issued and the authenticity of the application materials, records and data are responsible. The Measures also optimized the batch issuance process, clarified the batch issuance method and working time limit requirements, and strengthened the batch issuing agency and personnel management.