Kategorie: ‘Pharmaceutical Company News’
Shandong: issuing the Guiding Principles for the Construction of the Traceability System for Traditional Chinese Medicine Tablets in Manufacturing Enterprises
Recently, the Shandong Provincial Drug Administration issued “Guiding Principles for the Construction of the Traceability System for Traditional Chinese Medicine Tablets in Manufacturing Enterprises in Shandong Province.” The Guiding Principles will be in effect by February 1, 2023 and will be valid until January 31, 2026. According to the Guiding Principles, the traceability system should adhere to the NMPA’s technical standards for data exchange and gradually achieve interconnection with provincial, extra-provincial, and national data platforms. The traceability system should establish three major traceability modules: traceability modules of the raw materials of Chinese medicine tablets, traceability modules of the production quality of Chinese medicine tablets, and traceability models of the circulation and use of Chinese medicine tablets. In addition, the Guiding Principles standardize the composition of the traceability code, which should include information such as the name of the manufacturer, the batch number, the packaging specifications, and the date of production.
《山东省中药饮片生产企业信息化追溯体系建设指导原则》发布
来源：山东省人民政府 2023.01.06
近日，山东省药监局印发《山东省中药饮片生产企业信息化追溯体系建设指导原则》。《指导原则》自2023年2月1日起施行，有效期至2026年1月31日。《指导原则》指出，追溯系统应符合国家药监局制定的数据交换技术标准，逐步实现与省内、省外和国家数据平台的对接。追溯系统应建立中药饮片原材料信息追溯、中药饮片生产质量信息追溯和中药饮片流通使用信息追溯三大信息化追溯模块。另外，《指导原则》规范了追溯码的基本构成，追溯码应包含生产企业名称、饮片批号、包装规格、生产日期等信息。
Bozhou: developing a regional traceability system for traditional Chinese medicine tablets
Recently, the Anhui Provincial Drug Administration stated that Bozhou city has taken the lead in developing a regional traceability system for traditional Chinese medicine tablets, which has already covered 192 traditional Chinese medicine tablet manufacturers in the city. The traceability system consists of two main parts: the enterprise side and the supervisory side. The enterprise side of the traceability system manages procurement, production, warehousing, finance, sales, and other key aspects of the manufacturing process, allowing for real-time recording of the production process and track modification. The supervisory side can read data from and enter data into the enterprise side traceability platform. The supervisory side can assess enterprise data within its authority at any time and, if necessary, manage drug recalls, conduct intelligent analysis, and post information on the platform, allowing for digital supervision of the quality of traditional Chinese medicine tablets.
亳州率先建设区域性中药饮片信息化追溯体系
来源：搜狐 2022.12.22
日前，安徽省药监局称亳州市在全国率先建设的区域性中药饮片生产信心化追溯体系现已覆盖全市192家中药饮片生产企业。信息化追溯平台系统主要由企业端和监管端两部分构成。企业端追溯系统把控采购、生产、仓储、财务、销售等关键环节过程，能够实现生产全过程的实时记录与修改留痕。监管端可实现从企业端追溯平台自动读取、录入数据。监管部门可根据需要随时查询权限内的企业数据，完成药品的召回管理、智能分析及信息发布等内容，实现中药饮片质量的数字化监管。
Tianjin: implementing the 2022 “Month of Safe Drug Use” campaign in tandem with the campaign for the recall of expired drugs
The Tianjin Binhai Market Supervision Bureau, in collaboration with the People’s Pharmacy Company Ltd., implemented the 2022 “Month of Safe Drug Use” campaign on December 8. The program was carried out in the form of on-site teaching and explanation, as well as the distribution of brochures, especially for the elderly and other special groups, fulfilling the role of pharmacists. At the same time, it instructed the public to clean up expired drugs in their homes carefully and on time to avoid expired drugs damaging the environment or flowing back into the market illegally, so as to continually raise public awareness of environmental protection and safe use of drugs.
天津市滨海新区市场监管局开展2022年“安全用药月”暨过期药品回收宣传活动
来源：新浪财经 2022.12.09
12月8日，天津市滨海新区市场监管局联合老百姓大药房有限公司开展2022年“安全用药月”系列宣传活动。通过现场科普、现场讲解、发放宣传材料等形式开展宣传活动，重点针对老年人等特殊群体进行科普，发挥药师的药学服务作用。同时，引导群众及时、认真清理家庭过期失效药品，防止过期药品随意丢弃污染环境或者落入不法商贩之手重新流入市场，不断增强群众环境保护意识和安全用药素养。
Jiangxi: introducing 15 measures to support the development of pharmacy chains
Recently, Jiangxi province’s Medical Products Administration issued “Opinions on Supporting the Development of Pharmacy Chains.” The Opinions support large-scale drug wholesalers and pharmacy chains to acquire single-pharmacies in various ways; they support pharmacies within the same pharmacy chain to allocate drugs on demand; they support pharmacy chains to provide round-the-clock drug vending machines in public places; they support supermarket chains to sell OTC drugs of class B; they support pharmacy chains to implement remote pharmacy services and prescription review by licensed pharmacists and to establish remote pharmacy service centers; they support e-management of data in pharmacy chains; they encourage pharmacy chains to sell drugs on the internet and to keep prescriptions for patients with chronic diseases.
江西出台15条措施全面支持鼓励药品零售连锁企业发展
来源：江西省药品监督管理局 2022.12.02
近日，江西省药品监督管理局印发了《关于支持药品零售连锁企业发展的意见（试行）》。《意见》指出，重点支持大型药品批发企业、大型药品零售连锁企业集团通过多种形式整合单体药店；支持同一零售连锁企业门店之间按需相互调拨药品；支持药品零售连锁企业在大型公共场所内开设24小时自动售药机；支持连锁超市销售乙类非处方药；支持药品零售连锁企业开展执业药师远程药学服务及审方业务，鼓励药品零售连锁总部设立远程药学服务中心；支持药品零售连锁企业数据电子管理；鼓励连锁企业采用“互联网+”销售方式销售药品，推行慢性病处方留存制度。
NHSA：maintaining the “two-ticket policy”
The National Healthcare Security Administration has recently stated that the “two-ticket policy” still plays an important role in drug procurement in medical institutions. Therefore, it should not be abolished at this time.
国家医保局：两票制暂不取消
来源：医药网 2022.10.25
日前，国家医保局明确，医疗机构药品采购“两票制”仍然发挥着重要作用，目前不适合取消。
Tianjin: organizing the recycling of household expired drugs
In 2022, the Ninghe Distinct Market Supervision Bureau selected 50 rural pharmacies as household expired drug recycling centers to establish a household expired drug recycling network in 15 towns throughout the distirct. The Supervision Bureau made unified boxes for these expired drugs. They also developed a household expired drug recycling system and organize designated pharmacies to register, store and hand in expired drugs.
天津市宁河区市场监管局大力推进家庭过期药品回收
2022.10.11 来源：天津市宁河区市场管理监督局
2022年，宁河区市场监管局选定50家农村地区药店作为农村地区家庭过期药品回收单位，实现全区15个镇家庭过期药品回收网络的全覆盖。监督局统一制作并发放“家庭过期药品回收箱”，制定家庭过期药品回收管理制度并组织药品回收定点药店的负责人做好回收药品的登记、保管和上交工作。
Changchun: promote the development of the drug traceability system
Since this year, the Market Supervision Bureau of Changchun City, Kuancheng Branch, has urged pharmacies to register in the “Mashangfangxin” drug traceability platform and upload drug tracability data. Through drug warehousing and sales, drug tracability data will be collected so that the purchase, sales, and inventory of drugs can be checked to ensure drug safety.
吉林省长春市宽城区推进药品信息化追溯体系建设
来源：国家重要产品追溯体系 2022.07.27
今年以来，吉林省长春市市场监管局宽城分局督促药店入驻“码上放心”药品追溯平台并在平台上传药品数据，并通过药品入库验收、销售出库等环节收集到的药品追溯信息核对药品进销存情况。
Guangdong: Improve the modern drug distribution system
Recently, the Guangdong Provincial Drug Administration and the Department of Commerce jointly issued a “notice on improving the modern drug distribution system to promote the development of drug distribution.” The Notice proposes that modern logistics standards for drugs should be implemented in Guangdong province to make drug storage and transportation more efficient, cost-effective, standardized, and intelligent. To deliver drugs to both urban and rural areas, an efficient and safe drug distribution system should be established, as well as a cross-regional province-wide drug logistics supply chain. Large drug distributors should be primarily responsible for drug distribution while small and medium-sized drug distributors should support them.
广东加快完善现代药品流通体系，推进药品流通产业高质量发展
来源：医药经济报 2022.07.15
近日，广东省药品监管局和省商务厅联合印发《关于完善现代药品流通体系推进药品流通产业高质量发展的通知》（以下简称《通知》）。《通知》提出，应加快推动出台广东省药品现代物流标准，提升药品储存运输集约化、规范化、智慧化水平；推动完善城乡高效安全配送体系，打造跨区域全省药品物流供应链；加快培育大型现代药品流通骨干企业为主体，中小企业为补充的药品流通格局。
Hebei: promote the development of pharmacy chains
Recently, the Hebei Provincial Drug Administration issued “Opinions on Supporting the Development of Pharmary Chains.” The “opinions” advocate the connection between the prescription systems of physical and internet medical institutions and pharmacy chains. The “opinions” encourage pharmacy chains to allow patients with chronic diseases to buy prescription drugs with the same name and specifications in the same pharmacy chain without presenting the prescription if they have previously used this prescription in this pharmacy chain. The “opinions” also encourage pharmacy chains to establish remote prescription review centers to provide remote pharmacy services to patients and review prescriptions for them, which serves as a supplemental service for patients when licensed pharmacists are not on duty or are not at their working hours.
最新！河北出台26项创新举措 助力药品零售连锁企业发展
来源：搜狐网 2022.07.02
日前，河北省药品监督管理局印发《关于支持药品零售连锁企业发展的意见》（以下简称《意见》）。《意见》支持药品零售连锁企业与实体医疗机构、互联网医疗机构的互联互通，实现处方系统与连锁药店的配药无缝对接；支持药品零售连锁企业推行慢性病患者处方留存购药制度；鼓励药品零售连锁总部设立远程药学服务（审方）中心，开展远程药学服务和审方工作，作为执业药师不在岗或者非工作时段的补充服务。
Tianjin: implementing remote drug prescribing
Recently, the Tianjin City Fourth Regulatory Office advised pharmacy chains in their jurisdiction to implement remote drug prescribing. The Regulatory Office explained to pharmacy chains the requirements for implementing remote drug prescribing, as well as the standards that must be met and the concrete steps to be taken. They also evaluated the entire prescribing process, including generating prescription drug orders, initiating remote drug prescribing requests, pharmacist remote review of prescriptions, order confirmation and collection in the remote drug prescribing system, and making suggestions for the prescription process.
第四监管办指导药品零售连锁企业 开展远程药事服务工作
来源：天津市药品监督管理局 2022.06.10
近日，天津市第四监管办积极指导片区药品零售连锁企业开展远程药事服务工作。第四监管办帮助企业熟悉开展远程审方业务的实施条件、标准及具体工作程序，并对远程审方系统处方药销售订单生成、远程审方需求发起、药师审方及确认、销售订单释放及收款的全过程进行检查，并对进一步完善相关功能提出意见。