6月10日，黑龙江省林业和草原局组织制定的《林下刺五加复合种植技术规程》《林下山参复合生态栽培技术规程》《林下黄精复合种植技术规程》《林下赤芍复合种植技术规程》《林下龙牙楤木复合种植技术规程》《林下白鲜复合种植技术规程》《林下茖葱复合种植技术规程》等7项林下复合种植团体标准由省林学会正式发布。这一系列标准的落地实施，是黑龙江省积极响应国家林草局《关于促进林下经济发展的若干措施》的具体行动，率先打通国家二级公益林林下经济标准化发展路径，破解黑龙江省森林林下空间利用瓶颈，为全省林下特色种植产业高质量发展筑牢标准化根基、划定规范底线、指明前行方向。近年来，黑龙江省深入践行“绿水青山就是金山银山”理念与大食物观，依托广袤的森林资源，将林下经济作为林草产业转型升级、助力乡村振兴、推动生态产品价值实现的核心抓手。国家林草局相关政策明确提出，在坚守生态保护底线、不破坏森林生态功能的前提下，允许科学有序利用二级公益林、地方公益林发展林下经济，鼓励各地结合实际制定配套技术标准，实现森林资源空间复合利用与功能协同提升。此前，受技术规范缺失、经营模式模糊等因素制约，二级公益林林下资源开发始终面临“不敢用、不会用、乱利用”的困境，广阔的林下空间资源难以转化为产业优势与民生福祉。此次黑龙江省7项团体标准的出台，精准回应政策要求与产业痛点，实现生态保护与产业发展的双向统筹。此次发布的7项团体标准，聚焦林下山参、刺五加、黄精等七种龙江道地林药、林菜品种，结合本地气候与林地条件，贯穿种植全流程。标准区分商品林与公益林管理模式，针对二级公益林明确轻扰动整地、低密度栽植、生态化抚育等要求，坚持生态优先原则，既守护森林生态，又打通公益林合规利用技术壁垒。同时，整套标准搭建起黑龙江省林下复合特色种植标准化技术体系，针对传统散户经营模式粗放、产品品质不一、易破坏生态等问题，新规统一土壤、郁闭度、农药化肥使用等关键指标，细化各项实操流程，推广仿生态复合栽培模式。下一步，黑龙江省林业科学院将持续做好标准的宣传解读、技术推广与落地指导工作，组织技术人员深入林区、林场开展实操培训，引导经营主体严格按照标准规范生产，并持续完善林下经济标准体系，不断丰富标准品类，以标准化引领规范化、以规范化促进产业化，全力推动黑龙江省林下经济提质增效、行稳致远，真正把森林“四库”资源优势转化为生态优势、产业优势和民生优势，奋力书写新时代龙江林草高质量发展新篇章。

根据《贵州省医疗保障定点零售药店协议管理经办规程（试行）》（黔医保中心发〔2021〕26号）《贵州省医疗保障定点医疗机构协议管理经办规程（试行）》（黔医保中心发〔2021〕27号）要求，现将2025年第三批（第二轮）及2026年第二批拟新增为省本级医疗保障定点的12家医疗机构和2家零售药店名单予以公示。公示期间如对公示单位的相关资格有异议的，可通过来人、来电或来信等形式，直接向贵州省医疗保障事务中心反映，须提供真实姓名、工作单位和确切的联系方式，以便查结后回复，反映内容须实事求是，并提供反映问题的真实证据，受理部门将对反映信息予以严格保密。反映内容不实或隐瞒真实身份的，受理部门将不予受理。公示时间：7个工作日（2026年6月10日—2026年6月18日）受理部门电话：0851-85977752中心纪检部门电话：0851-85976461受理时间：工作日8:30-12:00,14:00-17:30附件-新增省本级基本医疗保障定点医药机构名单.xlsx序号医疗机构名称机构类型医药机构地址1息烽县养龙司镇中心卫生院医疗机构息烽县养龙司镇养龙司村龙腾路88号2贵阳市乌当区东风镇卫生院医疗机构贵阳市乌当区东风镇街上3修文县大石布依族乡卫生院医疗机构修文县大石布依族乡4修文县谷堡镇卫生院医疗机构修文县谷堡镇折溪村/乌栗村5贵阳市花溪区燕楼镇卫生院医疗机构贵阳市花溪区燕楼镇燕楼村6花溪区青岩镇卫生院医疗机构花溪区青岩镇交通路程252号7贵阳市花溪区久安乡卫生院医疗机构花溪区久安乡小山村8息烽县石硐镇卫生院医疗机构息烽县石硐镇石硐街和谐路210号9息烽县九庄镇中心卫生院医疗机构息烽县九庄镇兴隆路134号10贵阳观山湖一牙兔口腔门诊部医疗机构观山湖区世纪城街道金阳南路6号贵阳世纪城E组团购物中心三2层1号贵阳世纪金源购物中心C区三层童兜天地CF3S001A11南明新洲诊所医疗机构贵阳市南明区大理石路润丰家园4-5号楼负一层12号12云岩区黔灵镇社区第三卫生服务站医疗机构云岩区沙河村百花山二组29A13贵阳湘禾合朋大药房零售药店贵州省贵阳市花溪区石板镇合朋村三农创业发展有限公司二组团C区加一层商铺14清镇一树吾悦大药房（个人独资）零售药店贵州省贵阳市清镇市青龙山街道吾悦广场建设项目自14、20栋（20）1-5号贵州省医疗保障事务中心 2026年6月9日 

Delivery Method:VIA ELECTRONIC MAIL READ/DELIVERY RECEIPTProduct:DrugsRecipient:Rafael PadillaCEOFagron BVFascinatio Boulevard 3503065 WB RotterdamNetherlandsIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERWL # 724551May 12, 2026Dear Mr. Padilla:You registered your facility with the U.S. Food and Drug Administration (FDA) as an outsourcing facility under section 503B of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. § 353b]1 on April 21, 2017, and most recently on November 22, 2025. From October 9, 2025, to November 5, 2025, FDA investigators inspected your facility, Fresenius Kabi Compounding, LLC dba Fagron Sterile Services, located at 20 Dan Rd, Canton, MA 02021. During the inspection, investigators noted serious deficiencies in your practices for producing drug products intended or expected to be sterile, which put patients at risk.FDA issued a Form FDA 483 to your facility on November 5, 2025. FDA reviewed your facility’s responses, dated November 26, 2025, December 1, 2025, and December 5, 2025, and acknowledge receipt of your subsequent correspondence. FDA further acknowledges that your firm initiated a voluntary recall on February 5, 2026, of various lots of drug products, within expiry, produced using (b)(4) IV Bags intended or expected to be sterile due to lack of sterility assurance. Based on this inspection, it appears you produced drugs that violate the FDCA.A. Compounded Drug Products under the FDCAUnder section 503B(b) of the FDCA, a compounder can register as an outsourcing facility with FDA. Drug products compounded by or under the direct supervision of a licensed pharmacist in an outsourcing facility qualify for exemptions from the drug approval requirements in section 505 of the FDCA [21 U.S.C. § 355(a)], the requirement in section 502(f)(1) of the FDCA [21 U.S.C. § 352(f)(1)] that labeling bear adequate directions for use and the Drug Supply Chain Security Act requirements in section 582 of the FDCA [21 U.S.C. § 360eee-1] if the conditions in section 503B of the FDCA are met.2An outsourcing facility, which is defined in section 503B(d)(4) of the FDCA [21 U.S.C. § 353b(d)(4)], is a facility at one geographic location or address that — (i) is engaged in the compounding of sterile drugs; (ii) has elected to register as an outsourcing facility; and (iii) complies with all of the requirements of this section. Outsourcing facilities must comply with other applicable provisions of the FDCA, including section 501(a)(2)(B) [21 U.S.C. § 351(a)(2)(B)], regarding current good manufacturing practice (CGMP), and section 501(a)(2)(A) [21 U.S.C. § 351(a)(2)(A)], regarding insanitary conditions. Generally, CGMP requirements for the preparation of drug products are established in Title 21 of the Code of Federal Regulations (CFR) parts 210 and 211.B. Violations of the FDCAAdulterated Drug ProductsThe FDA investigators noted that drug products intended or expected to be sterile were prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health, causing your drug products to be adulterated under section 501(a)(2)(A) of the FDCA. For example, the investigators observed that:1. You exposed sterile drugs and materials to lower than ISO-5 quality air.Specifically, operators' arms blocked the first air to sterile vancomycin vials during reconstitution. Additionally, operators vigorously shook the vials during this process. This rapid movement likely disrupts the unidirectional airflow within the ISO 5 aseptic processing area, creating a contamination risk.2. You failed to perform adequate smoke studies under dynamic conditions to demonstrate unidirectional airflow within the ISO 5 area. Therefore, your products intended to be sterile are produced in an environment that may not provide adequate protection against the risk of contamination.Specifically, airflow visualization studies (i.e., smoke studies) do not accurately reflect the actual quantity and positioning of equipment, materials, and other components used during production. Consequently, it cannot be determined whether adequate, uninterrupted, unidirectional airflow is maintained throughout the aseptic drug production process.The FDA investigators also noted CGMP violations at your facility that caused your drug products to be adulterated within the meaning of section 501(a)(2)(B) of the FDCA. The violations include, for example:1. Your quality control unit failed to exercise its responsibility to ensure that drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality and purity (21 CFR 211.22).2. You failed to thoroughly investigate any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed (21 CFR 211.192).3. You failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile (21 CFR 211.113(b)).4. You failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas (21 CFR 211.42(c)(10)(iv)).5. You failed to establish an adequate system for cleaning and disinfecting the room and equipment to produce aseptic conditions (21 CFR 211.42(c)(10)(v)).6. You failed to maintain buildings used in the manufacture, processing, packing or holding of drug products in a good state of repair (21 CFR 211.58).Outsourcing facilities must comply with CGMP requirements under section 501(a)(2)(B) of the FDCA. FDA’s regulations regarding CGMP requirements for the preparation of drug products have been established in 21 CFR parts 210 and 211. FDA intends to promulgate more specific CGMP regulations for outsourcing facilities. FDA has issued a revised draft guidance, Current Good Manufacturing Practice — Guidance for Human Drug Compounding Outsourcing Facilities under Section 503B of the FD&C Act. This draft guidance, when finalized, will describe FDA’s expectations regarding outsourcing facilities and the CGMP requirements in 21 CFR parts 210 and 211 until more specific CGMP regulations for outsourcing facilities are promulgated.Under section 301(a) of the FDCA [21 U.S.C. § 331(a)], the introduction or delivery for introduction into interstate commerce of any drug that is adulterated is a prohibited act. Further, it is a prohibited act under section 301(k) of the FDCA [21 U.S.C. § 331(k)] to do any act with respect to a drug, if such act is done while the drug is held for sale after shipment in interstate commerce and results in the drug being adulterated.C. Corrective ActionsWe have reviewed your facility’s responses to the Form FDA 483, dated November 26, 2025, December 1, 2025, and December 5, 2025. We also acknowledge your firm initiated a voluntary recall on February 5, 2026, of various lots of drug products, within expiry, produced using (b)(4) IV Bags intended or expected to be sterile due to lack of sterility assurance.We are unable to fully evaluate some of your corrective actions due to lack of adequate supporting documentation:1. Regarding your firm’s failure to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic processes:a. We acknowledge your interim and long-term corrective action plans to address deficiencies in your current (b)(4) process for intravenous fluid bags. We note your intention to (b)(4) and, if necessary, (b)(4)—are implemented and qualified. Once these planned enhancements are complete, and the revised process implemented, FDA will evaluate the adequacy and safety of your (b)(4) processes. This evaluation will include an assessment to ensure there is no adverse impact on the quality of drug components and finished drug products.b. Regarding your firm's failure to ensure that personnel monitoring practices (i.e., gloved fingertip and gowned (b)(4) sampling) provide meaningful results, we acknowledge your plan to modify SOP # FSSBOS-SOP-0014, Aseptic Technique for the (b)(4) at the Canton Compounding Facility. However, the adequacy of this corrective action cannot be fully evaluated until the modifications are fully implemented and supporting documentation, such as executed batch production records, are provided for assessment.c. We acknowledge your plan to conduct a new “Dynamic Airflow Qualification” study to address your firm's failure to perform adequate smoke studies under dynamic conditions representative of actual production. However, since you estimate the study will not be complete until March 31, 2026, we cannot evaluate the adequacy of your corrective action at this time. We remain concerned about your inability to verify adequate airflow patterns within the ISO 5 aseptic processing area.2. Regarding your failure to establish an adequate system for cleaning and disinfecting the room to produce aseptic conditions:We acknowledge your response regarding the brown, rust-like residue found on the wheelbases of the laminar flow hoods and tables in your ISO 7 areas. We note your plan to update procedures to enhance inspection and cleaning of these surfaces as necessary. However, your response did not include evidence—such as photographs or other documentation—demonstrating that remedial actions (e.g., cleaning) have been completed. Without this documentation, we are unable to evaluate the adequacy of your corrective action at this time.3. Regarding your failure to maintain buildings used in the manufacture, processing, packing, or holding of drug products in a good state of repair, including paint chipping on air returns and a door, and a divot in the floor, all in ISO 7 areas:We acknowledge your plans to repair and refinish the affected air returns and doors, as well as to repair the floor. However, you failed to provide evidence, such as photos or executed work orders, demonstrating that the repairs have been completed. Consequently, we cannot evaluate the adequacy of your corrective action at this time.Some of your corrective actions appear deficient:1. Regarding your Quality Unit’s failure to exercise its responsibility to ensure drug products produced are in compliance with CGMP, and meet established specifications for identity, strength, quality and purity:We acknowledge the actions your firm has planned in response to its failure to adequately manage an adverse trend involving defects associated with your intravenous fluid bags. We note the following action items:Assess Fresenius Kabi vendor status based on review of defects noted.Target completion due date: 31Jan2025 [sic; date assumed to be 31Jan2026]Assess supplier qualification process regarding managing vendor complaints and escalations.Target completion due date: 31Jan2025 [sic; date assumed to be 31Jan2026]Update supplier qualification SOP based on closure of assessment.Target completion due date: 31Jan2025[sic; date assumed to be 31Jan2026]However, your response fails to address fundamental deficiencies in how your Quality Unit managed a significant adverse trend related to the container-closure system of your sterile drug products. For example, although the IV bag manufacturer/supplier acknowledged defects in the IV bags’ injection and infusion ports, they never communicated a definitive root cause. Without this root cause determination, you could not verify whether the manufacturer/supplier's corrective actions (e.g., equipment “maintenance”) adequately resolved the issue. Your firm continued to rely solely on visual inspection processes as the primary control mechanism to prevent defective units from reaching patients.Furthermore, requiring personnel to focus primarily on detecting port defects during visual inspection of finished sterile drug products raises concerns, as this may compromise their ability to identify particulates and other defects unrelated to ports.2. Regarding your failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed:We acknowledge the actions your firm has planned in response to its failure to adequately investigate and respond to an adverse trend involving defects associated with your intravenous fluid bags. We note the following action items:Assess bag storage and shipping configuration to determine if current storage & configuration has potential compressive stress on the seam of the (b)(4) IV Bag units.Target completion due date: 06Jan2026Assess the need for updates to the incoming inspection requirements of (b)(4) IV Bags.Target completion due date: 06Jan2026Update the customer complaint investigation process in FSSBOS-SOP-0041 to require that for “leaking unit” complaints, photos of the defective unit(s) are requested, and the units be returned to the facility for inspection.Target completion due date: 06Jan2026However, although you identified a trend involving defects with the (b)(4) infusion port seal across multiple supplier lots of various (b)(4) IV Bag configurations, you failed to take meaningful action such as pausing production or distribution. Instead, you opened an “Issue” to document and trend the events. You did not conduct a comprehensive risk analysis and never identified a definitive root cause. Despite failing to determine a definitive root cause through communication with the IV bag supplier ((b)(4)) for the observed defects—including (b)(4) port seals with (b)(4) “stress” marks, loose (b)(4) port seals, and partially seated (b)(4) port seals—you continued using these IV bags in production. You relied solely on visual inspection to identify and segregate defective units. This practice is inconsistent with good manufacturing practices, which require a drug process to remain in a state of control throughout its lifecycle. Knowingly using potentially defective container-closures in the production of a sterile drug product places the product at risk of contamination and puts patients at risk.3. Regarding your failure to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile:a. We acknowledge your response to the failure to ensure that operators’ behavior in the ISO 5 aseptic processing area does not block or otherwise compromise “first-air” to critical surfaces such as vials. We note your contention that vial reconstitution is not an aseptic practice, as well as your plans to reclassify this as such. However, sterile drug vial reconstitution is an aseptic process that must be performed in an ISO 5 area because it involves exposing a sterile product to the environment during manipulation. When reconstituting a sterile drug, the vial's closure system is breached to introduce a diluent, creating opportunities for microbial contamination. An ISO 5 environment provides the highest level of air cleanliness in the immediate work area, with stringent limits on airborne particulates that could carry microorganisms. This controlled environment, combined with proper aseptic technique, is essential to maintain product sterility and prevent contamination that could lead to serious patient harm. Additionally, while subsequent sterile (b)(4) of the bulk drug solution may provide a layer of protection, it does not eliminate the requirement to maintain aseptic conditions throughout the sterile drug production process.We further acknowledge your claim that vigorous shaking of the [vancomycin] vials is necessary to ensure complete dissolution of the drug in the diluent, as well as your intent to improve this process by requiring the hood to “(b)(4)” following reconstitution and prior to resumption of aseptic activities. However, this strategy fails to address the primary risk. As previously stated, rapid movement (i.e., vigorous shaking of vials) creates significant air turbulence that disrupts laminar airflow and increases contamination risk. A (b)(4) alone without supporting scientific evidence is not an effective contamination control strategy.b. We acknowledge your response regarding the failure to conduct all aseptic operations, including reconstitution of sterile vials and pooling of the resultant bulk drug solution, in a properly qualified ISO 5 environment. As previously stated, reconstituting sterile drug product vials and pooling them outside an ISO 5 environment creates a direct contamination risk. When performed outside an ISO 5 space, the process is no longer considered a sterile-to-sterile aseptic process. While we acknowledge the information you provided regarding sterilizing (b)(4) qualification (including compatibility and capacity) and additional controls such as full gowning, environmental monitoring within the ISO 7 mixing room, and sanitization of pooling bags, these measures do not replace the comprehensive validation process, including process simulation studies, necessary to validate such a process.4. Regarding your failure to establish an adequate system for monitoring environmental conditions in aseptic processing areas:We acknowledge your response regarding the failure to adequately perform active and passive air sampling within the ISO 5 area during aseptic operations, including your plan to initiate active air monitoring during filling operations. We recognize the importance of conducting effective environmental monitoring while minimizing the risk of contamination. However, your response fails to fully address the scope of the violation. Although conducting viable air sampling during filling represents an improvement, it does not address other critical steps in the aseptic operation where contamination risk is high and viable air monitoring may be necessary. Additionally, your response does not specify the duration of the production process or explain whether the frequency of viable air sampling adequately represents the processing environment throughout the entire production cycle. Furthermore, your response indicates that settle plate placement is described in FSSBOS-SOP-0013, “Cleaning Procedure for Classified Areas at the Canton Compounding Facility.” However, our review of this SOP indicates that it applies only to ISO-7, ISO-8, and ISO-9 areas. Consequently, the location of settle plates, used for passive air monitoring of the ISO 5 (b)(4) during aseptic operations, cannot be determined.In addition to the issues discussed above, you should note that CGMP requires the implementation of quality oversight and controls over the manufacture of drugs, including the safety of raw materials, materials used in drug manufacturing, and finished drug products. See section 501 of the FDCA. If you choose to contract with a laboratory to perform some functions required by CGMP, it is essential that you select a qualified contractor and that you maintain sufficient oversight of the contractor’s operations to ensure that it is fully CGMP compliant. Regardless of whether you rely on a contract facility, you are responsible for assuring that drugs you produce are neither adulterated nor misbranded. [See 21 CFR 210.1(b), 21 CFR 200.10(b)].FDA strongly recommends that your management undertake a comprehensive assessment of operations, including facility design, procedures, personnel, processes, maintenance, materials, and systems. In particular, this review should assess your aseptic processing operations. A third party consultant with relevant sterile drug manufacturing expertise should assist you in conducting this comprehensive evaluation.D. ConclusionThe violations cited in this letter are not intended to be an all-inclusive statement of violations at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.You should take prompt action to address any violations. Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to address any violations. Please include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. This letter notifies you of our concerns and provides you an opportunity to address them. If you believe your products are not in violation of the FDCA, include your reasoning and any supporting information for our consideration. If you cannot completely address this matter within fifteen (15) working days, state the reason for the delay and the time within which you will do so.All correspondence should refer to the Warning Letter Number above (# 724551) and include a subject line that clearly identifies the submission as a Response to Warning Letter. If you have questions regarding the contents of this letter, please contact compoundinginspections@fda.hhs.gov.Sincerely,/S/Matthew J. LashActing DirectorOffice of Compounding Quality and ComplianceOffice of ComplianceCenter for Drug Evaluation and Researchcc:Deborah E. McHugh, Vice President of Quality for North AmericaFresenius Kabi Compounding, LLC20 Dan RdCanton, MA, 02021-2809___________________1 See Pub. L. No. 113-54, § 102(a), 127 Stat. 587, 587-588 (2013).2 We remind you that there are conditions, other than those discussed in this letter, that must be satisfied to qualify for the exemptions in section 503B of the FDCA.

为了进一步规范特殊食品注册申报，做好受理审评工作，现将有关要求公告如下：一、注册申请人现场提交行政许可项目申报材料、领取许可决定文书或配合开展特殊食品注册现场核查工作时，具体办理人员应当为注册申请人正式在职员工（现行法律法规有其他要求的情形除外），须同时提交注册申请人（与申请表盖章单位一致）向具体办理人员出具的授权委托书，以及具体办理人员的身份证明原件及复印件（原件核对后退回）。授权委托书参考式样详见附件1、附件2、附件3。二、注册申请人在注册、备案系统注册账号或者申报具体产品时，在注册系统和申请表中填写的联系方式应为注册申请人正式在职员工的联系方式（现行法律法规有其他要求的情形除外）。三、对于保健食品注册申请的联系人或联系方式等信息发生改变的，申请人可通过现场或邮寄的方式，及时向我中心受理大厅提交《保健食品联系方式变更申请书》。我中心将根据注册申请人提供的信息对保健食品注册审评系统中具体产品的联系人、联系方式等信息进行更新。对于信息更新不及时影响注册审评及注册现场核查工作开展的，由申请人承担相应责任。四、注册申请人应对提交的上述材料的真实性负责。经审核发现不属实的，将按《中华人民共和国行政许可法》中“隐瞒有关情况”或者“提供虚假材料”的情形处理。本公告内容自2026年6月9日起执行。特此公告。附件:1.授权委托书—办理行政许可事项受理业务用2.授权委托书—办理行政许可决定文书领取业务用3.授权委托书—办理特殊食品注册现场核查业务用国家市场监督管理总局食品审评中心2026年6月9日

各药品生产企业：为贯彻落实《国务院办公厅关于印发中医药振兴发展重大工程实施方案的通知》(国办发﹝2023﹞3号)《国家药监局农业农村部国家林草局国家中医药局关于发布〈中药材生产质量管理规范〉的公告》(2022年第22号) (以下简称《公告》)《中药生产监督管理专门规定》精神，进一步加强《中药材生产质量管理规范》(以下简称GAP)延伸检查管理，促进云南省中药材规范生产和中药产业高质量发展，现将有关事宜通知如下：一、工作目标认真贯彻落实党的二十大精神和习近平总书记关于中药传承创新发展的重要指示批示精神，结合云南省《关于加强中药科学监管促进中药传承创新发展具体措施》，高质量推动GAP监督实施。通过GAP延伸检查、符合性检查和日常监督检查以及其他专项检查，引导和督促中药生产企业(中药饮片、中药配方颗粒生产企业和中成药上市许可持有人，下同)自建、共建、共享（名词解释见附件2）中药材种植养殖基地，加大GAP药材使用力度，从源头上稳定中药材供给，提升我省中药产品质量安全保障水平，促进中药产业高质量发展。二、工作内容（一）加强重点企业和品种监管。加强重点企业、重点品种、重点环节风险研判，对中药注射剂、中药配方颗粒、集（联）采中药和采购产地加工（趁鲜切制）中药材生产中药、中药饮片的监督检查，依托年度检查计划，有序开展GAP延伸检查。鼓励和督促重点中药生产企业采取自建、共建、共享的方式，开展GAP基地规范化建设。中药生产企业应当在《药品生产质量管理规范》体系下建立GAP相关专业机构和人员团队，结合中药材供应商审核，将质量管理体系主动延伸到中药材生产环节。以中药注射剂、中药配方颗粒GAP延伸检查为抓手，推动我省中药生产企业贯彻落实《中药生产专门管理规定》相关要求，使重点企业和重点中药产品中药材原料源头追溯和使用GAP药材的规定得到有效执行。（二）规范“药材符合GAP要求”标识管理。中药生产企业可根据GAP及相关技术要求研究制定内部评估标准，对本企业中药产品使用的GAP药材情况，包括但不限于基原及种质、产能产量及持续供给等信息开展评估，自评达到要求的，可按《药品说明书和标签管理规定》办理相关手续，在药品标签中标示“药材符合GAP要求”。复方中成药应当在处方中的所有药味均使用GAP药材后方可标示。未完全或完全使用GAP药材生产的批次不得标示。（三）进一步规范GAP延伸检查管理。云南省药品监督管理局（以下简称省药监局）对标示使用GAP药材的中药生产企业和产品，按年度检查计划开展常规检查，必要时开展延伸检查。中药生产企业可按照《云南省〈中药材生产质量管理规范〉延伸检查申请表》（附件1）的要求，在云南省政务服务网（https://zwfw.yn.gov.cn）上向省药监局提出中药材GAP延伸检查的申请，省药监局将依申请适时组织开展延伸检查。中药生产企业主动提出中药材GAP延伸检查的，必须实际生产有标示“药材符合GAP要求”的产品。延伸检查检查结果在省局网站上公示，公示内容包括：被检查主体、中药产品（包括产品批号）、中药材品种（包括产品批号）、中药材生产企业、基地面积（亩）、基地地址（包括地址坐标经纬度）、检查结果；检查结果为不符合要求的，企业应当主动召回产品，相关产品不得标示“药材符合GAP要求”。中药材产地不在云南省辖区的，省药监局视情况独立开展或商请中药材产地省级药品监管部门联合或者协助检查；对中药材产地省级药品监管部门或者其他省级药品监管部门已完成延伸检查的，可以在沟通交流基础上互认结果。三、延伸检查的形式延伸检查采用现场核查或形式审查方式开展。（一）对从未开展过延伸检查的药品生产企业或中药材品种，省药监局将组织采用现场核查方式开展延伸检查，对中药企业产品标示了“药材符合GAP要求”来源的中药材生产企业GAP基地进行现场核查，确认是否符合GAP的要求。（二）对满足以下情形的药品生产企业，省局将以形式审查方式开展延伸检查，不再进行现场核查，但省药监局将其纳入日常监管范围，实施动态管理，并视情况开展抽查或现场核查。一旦发现提供虚假材料或存在重大质量安全隐患的，将依法严肃处理，并通报GAP药材生产企业所在地人民政府。1.已通过云南省及其他省级药监部门GAP延伸检查的GAP基地（包括云南省辖区之外的），使用同基地同品种同批号药材的，可免于现场核查。但应当提供相关证明材料（如：完整的检查报告、整改情况等）。2.已通过云南省及其他省级药监部门GAP延伸检查的GAP基地（包括云南省辖区之外的），种植多年生多次采收的中药材品种，其生产与质量管理体系未发生重大变更、种植品种未进行大规模替换的可免于现场核查。重大变更包括但不限于基地地址变更、质量管理负责人变更、关键生产技术变更等。3.已通过云南省基地评价的GAP基地，使用同基地同品种同批号GAP药材的，可根据风险评估结果免于现场核查。风险评估因素包括但不限于：品种特性、历史检查情况、质量追溯数据、企业信用状况等。不进行GAP基地现场核查的，药品生产企业应当提供中GAP基地的相关资料如下：1.GAP延伸检查通过证明文件；2.GAP基地资质文件；3.品种种植/养殖历史资料；4.质量追溯体系运行记录；5.质量协议或购销合同；6.上一周期检查的整改报告（如有）。 附件：1.云南省《中药材生产质量管理规范》延伸检查申请表      2.名词解释                               云南省药品监督管理局                               2026年6月8日    

《江西省市场监管局关于明确食品用塑料包装容器工具等制品等3种食品相关产品生产许可申报条件核查检查及审批方式等有关事项的通知》已发布（见附件）。江西省市场监督管理局2026年6月4日   （此件公开发布）附件：《江西省市场监管局关于明确食品用塑料包装容器工具等制品等3种食品相关产品生产许可申报条件核查检查及审批方式等有关事项的通知》

为切实保障公众用械安全，台州市局坚持问题导向与风险闭环管控相结合，持续压实主体责任，夯实监管根基，深化信用分级，筑牢医疗器械经营领域安全底线。一是拧紧“责任链”，推动企业主动履责。聚焦提升企业第一责任人意识，推进医疗器械经营质量管理体系年度自查，对曾受行政处罚、存在不良信用记录、从业人员信息化水平偏低等三类主体实施“一对一”现场帮扶指导，督促企业严格对照质量管理规范开展自查自纠。同时，分层级、分领域强化法规宣贯培训，引导无实际经营意愿的企业主动注销许可（备案）。截至目前，全市企业年度自查率达96%，自查发现问题处置率100%，累计引导178家企业主动退出市场，行业自律水平显著提升。二是练好“基本功”，夯实基层监管根基。着力破解基层监管力量薄弱、标准不一等难题，推进基层医疗器械监管队伍规范化建设，制定基层所监管“应知应会”清单、实用检查指南及标准化检查记录表，进一步优化完善监管机制，实现检查流程、文书、尺度“三统一”。目前已组织基层监管人员专题培训2场次，累计培训100余人次，有效提升一线人员专业能力和检查规范性。三是绘好“精准像”，提升靶向监管效能。构建“分级+信用”监管模式，制定医疗器械经营企业质量安全信用评定标准，从遵纪守法、主体责任落实、监督检查结果、社会责任履行、正向激励等五个维度综合赋分，划分为四个监管级别，实行差异化、精准化检查。2026年，全市3278家经营企业已全部完成信用评定，按风险等级累计排查企业574家次。

　　根据国家药监局综合司《关于加强医疗器械注册备案信息发布工作的通知》（药监综械注函〔2024〕52号），现公布我市2026年5月注册审批第二类医疗器械产品目录集。

近日，省药监局印发《安徽省医疗机构应用传统工艺配制中药制剂备案申报资料编撰要点》，进一步规范我省医疗机构应用传统工艺配制中药制剂备案管理，保障备案工作质量，提升备案工作效率。《编撰要点》将制剂名称及命名依据、说明书及标签设计样稿、处方组成来源及理论依据、配制工艺及工艺研究资料、质量研究试验资料、原辅料来源及质量标准等16大项申报资料细化为41小项，逐项明确申报资料编制要求。《编撰要点》一是突出规范性。如统一备案表格填写规则、说明书标签版式及全项资料填报标准，明确制剂名称不得使用“宝、灵、强力、速效”等夸大暗示用词，细化处方溯源、临床佐证材料报送相关规范。二是突出科学性。如限定提取溶剂仅可选用水、植物油、蒸馏酒、规定浓度乙醇，细化工艺小试中试、工艺验证、质量方法学验证要求，相关研究均需留存完整试验数据与对应图谱。三是突出实用性。如结合院内临床实际划分毒理试验豁免条件，明确长期临床使用、古代经典名方等情形可豁免相关试验，含毒性药材、配伍禁忌品种需补充安全性研究，切实降低合规申报成本。

为构建权责清晰、科学高效、规范有序的医疗机构中药制剂管理体系，近日，省药监局印发《关于进一步加强全省医疗机构中药制剂注册和备案管理的通知》。《通知》要求，一是规范申报资料编制，医疗机构开展制剂备案应按照《安徽省医疗机构应用传统工艺配制中药制剂备案申报资料编撰要点》要求，形成真实、完整、科学的备案资料。二是开展标准提升行动，医疗机构应对已获批或备案制剂开展标准自查，发现检测项目不全、限度不合理等问题的，应及时修订并申报标准变更。三是规范说明书管理，持续完善中药制剂说明书的不良反应、禁忌、注意事项等安全信息。四是强化制剂变更管理，依规开展处方、工艺等变更研究，确保中药制剂使用安全有效。五是严格调剂使用监管，对近一年抽检不合格、检查存在严重缺陷的品种不予调剂。《通知》明确，省局将进一步凝聚监管工作合力，加强中药制剂备案政策法规宣贯，强化中药制剂研发与备案工作技术指导，为全省中药制剂规范、创新发展提供坚实保障。