The National Medical Products Administration (NMPA) has released a notification regarding the implementation of the \u201cDecision of the State Council on Amending and Abolishing Some Administrative Regulations.\u201d This move is part of a broader effort to streamline regulatory processes and enhance market vitality in the medical sector.<\/p>\n\n\n\n
Key Reforms and Changes<\/strong> Additionally, the “approval of Internet information services for drugs and medical devices” will be changed to a filing management system. This reform is a significant step in the State Council\u2019s \u201cSeparating Operating Permits from Business Licenses\u201d initiative, aimed at reducing bureaucratic red tape and stimulating market activity in the medical regulation field.<\/p>\n\n\n\n Post-Reform Procedures<\/strong> For entities intending to provide Internet information services for drugs and medical devices, filing with the local provincial medical products administration department is required. Until specific measures for filing management are released, the filing materials must align with the requirements of the “Separating Operating Permits from Business Licenses” reform deepening pilot work, where submitting the materials equates to the completion of filing.<\/p>\n\n\n\n
According to the document, from January 20, 2025, China will cancel the following approvals:<\/p>\n\n\n\n\n
After the cancellation of the above approval items, applicants seeking to establish drug wholesale and retail enterprises can file for a drug business license from the local medical products administration department at or above the county level, in accordance with relevant laws and regulations. Medical institutions that use radioactive drugs will no longer need to apply for a “Radioactive Drug Use License.” However, those using formulated radioactive preparations should apply to the provincial medical products administration for the issuance of a corresponding level of license.<\/p>\n\n\n\n