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Archive for July, 2023

Anhui: establishing traceability system for Traditional Chinese Medicine

July 31st, 2023 | by

The Anhui Medical Product Administration recently organized a conference on the traceability system for Traditional Chinese Medicine (TCM). During the meeting, a staff member of the administration interpreted related legal documents, particularly the “Coding Standards of the Tracing Code of TCM,” “Labeling Standards of the Tracing Code of TCM,” and “Standards of Code Mapping between Anhui Provincial Traceability Platform of TCM and Information Systems of TCM Manufacturers.” Participating TCM manufacturers addressed the aforementioned standards and provided recommendations for the identification of traceability codes and packaging specifications, data mapping, and data safety. The Anhui Medical Product Administration will consider these suggestions and revise the TCM traceability criteria, advising TCM manufacturers to appropriately reform their information systems for data mapping to the Anhui Provincial Traceability Platform of TCM.

安徽持续推进中药饮片信息化追溯体系建设

来源:中国食品药品网  2023.07.31

近日,安徽省药监局召开中药饮片信息化追溯讨论会。会上,安徽省药监局相关人员解读了中药饮片追溯相关法规文件,重点讲解了《安徽省中药饮片追溯码编码规范(征求意见稿)》,《安徽省中药饮片追溯码标识规范(征求意见稿)》,《安徽省中药饮片信息化追溯平台与企业自建系统数据对接规范(征求意见稿)》等。与会中药饮片企业围绕上述规范展开研讨,针对追溯码产品标识、包装规格标识以及数据对接、数据安全等问题提出意见建议。结合企业提出的意见建议,安徽省药监局将进一步完善中药饮片信息追溯相关规范,指导企业对照规范适当改造自建系统与安徽省中药饮片信息化追溯平台进行数据对接。

NHSA: releasing the “Standards of the Contract Renewal of Reimbursed Drugs”

July 24th, 2023 | by

Recently, the National Healthcare Security Administration (NHSA) adjusted and released the “Standards of the Contract Renewal of Reimbursed Drugs,” which clarified the adjusted payment standards covering the entire life-cycle of drugs: A drug that has been on the reimbursement list for 8 years will stay on the list permanently; the price reduction of a reimbursed drug would be halved if this drug has been on the reimbursement list for more than 4 years and the price reduction is triggered by contract renewal or additional indications for this drug; innovative drugs, biological goods, and traditional Chinese medicines that have already been approved by the Measures for the Administration of Drug Registration can renew the contract through renegotiations with the state if the price reduction is triggered.

基本覆盖药品全生命周期 国家医保局发布谈判药品续约规则

来源:广东省人民政府  2023.07.24

国家医保局日前对《谈判药品规则续约》进行调整完善并发布,明确建立基本覆盖药品全生命周期的支付标准调整规则:对达到8年的谈判药纳入常规目录管理;对未达8年的谈判药,连续协议期达到或超过4年的品种以简易方式续约或新增适应症触发降价的,降幅减半;对于按照现行注册管理办法批准的1类化药、1类治疗用生物制剂,1类和3类中成药,在续约触发降价机制时,可以申请以重新谈判的方式续约。