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For Immediate Release: July 10, 2025 Statement From: As I mark my hundredth day on the job at the FDA, I’m proud to celebrate the agency’s accomplishments in the bipartisan effort to Make America Healthy Again. I came here with big questions: Why does it take ten years for a drug to reach patients? How can we fix America’s food supply so it is not filled with harmful chemicals and additives? Why are childhood chronic diseases so prevalent? We are taking bold action to address these big, obvious problems, and more, which have been staring at us for years. The FDA regulates products that account for 20% of all U.S. consumer spending, and our work impacts the lives of every American. Over the past 100 days, we’ve launched dozens of key initiatives across the full range of the FDA’s purview to help make food healthier for children and families, accelerate meaningful cures and treatments, and modernize the agency with transparency, gold-standard science and common sense. Highlights include: Food – Healthier Food for Children Fixing America’s Food Supply Petroleum-based food dye removal – Took action to phase out petroleum-based synthetic food dyes from the U.S. food supply, which are linked to numerous health risks. Improving infant formula – Continued the work of Operation Stork Speed by hosting an expert roundtable on infant formula and exploring new ways to bring additional and healthier options without ingredients like seed oils, added sugars and heavy metals to market. Food chemical review – Initiated a robust, transparent review of chemicals currently in the food supply, such as BHT, BHA and ADA; and expedited the review of chemicals currently under review, such as phthalates, propylparaben and titanium dioxide. GRAS reform – Exploring rulemaking to require “generally recognized as safe” (GRAS) submissions to FDA to stop industry’s long-standing practice of introducing ingredients into the food supply without FDA knowledge or oversight. Natural food dyes – Approved uses of three food colors derived from natural sources: Galdieria extract blue, butterfly pea flower extract and calcium phosphate, and initiated an accelerated the review of other natural alternatives. Began revising broken dietary guidelines – Launched the Nutrition Regulatory Science Program in partnership with NIH to better address highly relevant questions for Americans’ health, such as the impact of ultra-processed foods and the effect of certain food additives. Defining ultra-processed foods – Will launch FDA/USDA request for data and information to help develop a uniform definition of ultra-processed foods, and industry roundtable, paving the way for additional study and action. More Meaningful Cures, Treatments and Diagnostics Accelerating Cures Reducing animal testing – Published a roadmap to transition away from animal testing for investigational new drug applications wherever possible and use more effective, human-relevant methods, such as organ-on-a-chip systems, advanced computer simulations, and pre-existing international data. Announced the intent to launch a pilot program in which select monoclonal antibody developers may pursue a primarily non-animal-based testing strategy, under close FDA consultation. Commissioner’s National Priority Voucher program – Announced a pilot program to expedite drug review processes from 10-12 months to 1-2 months following submission of a final application addressing U.S. national priorities, such as tackling a major health crisis or unmet public health need, increasing domestic drug manufacturing, and delivering more innovative cures for the American people. Revised Covid-19 vaccine regulatory framework – Adopted a new evidence-based approach to Covid-19 booster approvals, replacing a one-size-fits-all regulatory framework and broad marketing authorizations with a risk-stratified approach that is already embraced by most doctors and parents. Updated labeling of mRNA shots to include new safety information about myocarditis and pericarditis. Addressed industry influence – Limited the circumstances where individuals employed at FDA-regulated companies, such as pharmaceutical companies, may serve as members of FDA advisory committees, where statutorily possible, to mitigate perceived conflicts of interest and strengthen integrity to the review process. CEO Listening Tour – Launched a six-city listening tour to meet directly with pharmaceutical and biotech executives, gathering honest feedback and big ideas to help the agency better accelerate cures and innovation. Cell and Gene therapy innovation – Engaged dozens of industry experts in a roundtable to shape actions that will ensure America leads at the forefront of innovation in this space. Removed restrictions on certain gene therapies – Removed REMS requirement for currently approved BCMA- and CD19-directed autologous chimeric antigen receptor CAR T cell immunotherapies, the first of many steps towards a more common-sense regulatory approach in this space. Diagnostics to empower healthy decisions – Cleared the first in vitro diagnostic device that tests blood to aid in diagnosing Alzheimer’s disease. Initiated process to remove regulations on Laboratory Developed Tests (LDTs). Extended-release drug labeling change – Revised labeling on extended-release stimulants for ADHD treatment, cautioning parents and providers about the risks of adverse reactions, including weight loss, when used by children under six. Administration – Gold-Standard Science & Common Sense Protecting American Consumers Combatting illegal vapes – In collaboration with U.S. Customs and Border Protection, seized nearly $34 million worth of illegal, youth-appealing e-cigarette products originating in China. Protecting the microbiome from fluoride tablets – Initiated action to remove concentrated ingestible fluoride prescription drug products for children from the market, which were not FDA-approved and have been shown to alter the gut microbiome. Examining talc – Hosted an expert panel to review the latest evidence and discuss potential health risks associated with talc used in food, drugs and cosmetics. Unannounced foreign inspections – Expanded the use of unannounced foreign inspections where appropriate, holding domestic and international drug manufacturers to the same high standard. Holistic inspection policy review – Began comprehensive review of the agency’s policies and practices for foreign inspections (including policies related to travel accommodations), ensuring the FDA remains the gold standard for regulatory oversight. Protecting American’s biological samples – Initiated action to review and, where necessary, halt clinical trials which involve exporting Americans’ living cells and DNA to labs in hostile countries, such as China, for genetic engineering and subsequent infusion back into U.S. patients. Enhancing drug importation – Fought high prescription drug prices by working to streamline the process by which states can pursue importation of safe, effective and affordable drugs from Canada, without imposing additional risk to public health and safety. Cracking down on falsified data – Discovered that third-party testing companies in China were producing falsified or otherwise invalid data; acted swiftly to protect the integrity of the premarket application process and the medical device supply chain. Fighting “gas station heroin” –Issued warning letters against companies distributing and selling unlawful tianeptine products, warned health care professionals and the general public about the extensive adverse events associated with tianeptine use. FDA import alerts – Updated several import alerts – for certain dietary supplements, cheeses, seafood, fish products and more – to help prevent illegal and unauthorized products flooding the U.S. market and risking American’s safety and health. Unleashing AI and Big Data AI-assisted review – Completed a successful first AI-assisted scientific review pilot, demonstrating that internal AI tools can greatly reduce the time reviewers spend on mundane tasks or non-productive busywork. Equipping reviewers with internal AI tools – Launched Elsa, a generative AI tool designed to help all FDA employees – from scientific reviewers to investigators – work more efficiently. Elsa is just an initial step in the FDA’s larger plans to integrate AI into agency processes. Building a better adverse event reporting database – Launched a comprehensive effort to consolidate disparate adverse event reporting databases, which will enable far more effective post-market monitoring of drug products. Modernization and Radical Transparency Transparent communications – Created FDA Direct , a regular channel for communicating directly with the public through frequent, unscripted conversations with the FDA Commissioner about strategic updates and the thinking behind key agency decisions. Transparent agenda – In the Journal of the American Medical Association , provided a clear outline of FDA leadership’s priorities for modernizing and improving the agency in the months ahead. Transparent decision making – Began publishing, to the greatest extent possible, decision letters issued in response to applications for new drugs and biological products. I’m excited by what the talented FDA team have been able to achieve in 100 days by embracing gold-standard science, radical transparency and common sense. This is just the beginning. We’ll continue to introduce initiatives to modernize the agency, protect consumers, bring more meaningful cures, treatments and diagnostics to patients, and make healthier food available for children, using the best science and data to Make America Healthy Again. Related Information ### Boilerplate The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products. Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

药用辅料作为药物制剂的关键组成部分，其质量安全直接影响药品的有效性和患者用药安全。随着全球医药产业的快速发展和仿制药一致性评价工作的深入推进，药用辅料质量标准体系的完善显得尤为重要。本文以《中国药典》《美国药典》和《欧洲药典》为研究对象，系统比较了三者在药用辅料微生物控制标准方面的异同。研究发现，虽然三国药典均建立了相关标准体系，但在微生物限度要求、检测方法、风险评估等方面存在显著差异。通过深入分析这些差异及其成因，本文旨在为完善我国药用辅料微生物控制标准体系提供科学依据，促进药品质量提升和产业健康发展。(一)三国药典标准体系的整体架构比较1.1 通则标准的异同分析三国药典在药用辅料微生物控制的通则设置上既有共性又各具特色。《中国药典》2020年版通过<0251>药用辅料和<9602>药物制剂用药指南等通则，初步构建了微生物控制的基本框架。《美国药典》2022年版则通过<1115>非无菌原料药及其制品生物负荷控制等章节，更强调基于风险的控制策略。《欧洲药典》10.8版在<5.1.4>非无菌的制剂和药用辅助剂的微生物控制中，体现了更细致的分类管理思想。值得注意的是，三国药典在微生物检测的基本方法上保持了一致性，均采用需氧菌总数（TAMC）和霉菌及酵母菌总数（TYMC）作为主要指标，基础限值也统一设定为1000 CFU/g和100 CFU/g。这种一致性反映了国际药品标准协调的成果，为跨国药品注册提供了便利。1.2 各论收载情况的对比研究在药用辅料品种收载方面，三国药典呈现出明显的数量差异。《美国药典》以509个品种居首，《欧洲药典》收载347个，而《中国药典》则收载335个，虽然较2005年版的73个有显著增加，但仍存在较大提升空间。交叉分析显示，仅有164个品种同时被三国药典收载，这些"核心品种"主要集中在常用辅料如明胶、甘油、纤维素类等。这种收载差异反映了各国医药产业的特点和监管重点。欧美药典更注重收录新型功能性辅料，而《中国药典》在传统辅料方面更为全面。随着我国创新药物研发的加速，增加新型辅料的收载应当成为未来药典修订的重点方向。(二)微生物控制关键指标的比较研究2.1 微生物限度要求的差异化分析虽然三国药典设定了相同的基准限值，但在具体执行上存在明显差异。数据显示，《中国药典》中76%的辅料直接采用通则标准，而《欧洲药典》这一比例仅为57%，更多辅料采用了个性化限值。以滑石粉为例，《中国药典》统一要求TAMC≤1000 CFU/g，而欧美药典则根据给药途径（局部用药或口服）分别设定100 CFU/g或1000 CFU/g的标准。这种差异反映了风险管理理念的应用程度不同。欧美监管体系更强调“基于风险、分级管理”的思路，根据辅料特性和用途灵活调整标准。我国在标准个性化方面仍有提升空间，需要加强辅料特性与微生物风险关联性的研究。2.2 控制菌检查项目的对比在控制菌检查方面，三国药典的差异更为显著。《中国药典》主要关注大肠埃希菌和沙门菌，要求沙门菌检查的辅料占比仅为36%。相比之下，《欧洲药典》要求沙门菌检查的比例高达76%，且增加了对金黄色葡萄球菌、铜绿假单胞菌等致病菌的监控。这种差异部分源于辅料来源的不同。欧美国家更广泛使用动植物来源的辅料，这些材料携带致病菌的风险较高。随着我国药用辅料来源的多样化，适当扩大控制菌检查范围，建立更全面的致病菌监控体系显得尤为重要。(三)标准实施中的方法学挑战3.1 特殊辅料的检测难题许多药用辅料具有难溶性、抑菌性或吸附性等特点，给微生物检测带来挑战。研究发现，三国药典中针对特殊辅料的检测方法指导严重不足。《中国药典》仅有3个辅料各论提供了专门的检测方法，《欧洲药典》也仅有4个。这种缺失导致企业在实际检测中常常面临方法不统一、结果不可比等问题。解决这一问题需要加强方法学研究，特别是针对以下几类特殊辅料：（1）油溶性辅料；（2）具有抑菌活性的辅料；（3）高吸附性辅料。建议通过系统实验验证不同前处理方法对回收率的影响，建立科学可靠的标准操作流程。3.2 标准与用途的关联性不足药用辅料的功能多样性是其重要特点，同一辅料可能用于不同剂型和给药途径。然而，《中国药典》尚未建立微生物标准与预期用途的关联机制。数据显示，欧美药典中各有7个辅料根据用途设定差异化标准，而我国药典中这一做法尚未得到应用。建立用途关联的标准体系需要考虑以下因素：（1）给药途径（注射、口服、局部等）；（2）患者群体（成人、儿童、免疫缺陷者等）；（3）制剂特性（液体制剂、固体制剂等）。这种差异化管控既能保证安全，又可避免过度检测带来的资源浪费。(四)标准体系优化的路径建议4.1 建立科学的风险评估框架建议借鉴ICH Q9质量风险管理理念，构建药用辅料微生物专项风险评估工具。评估要素应包括：（1）原料来源风险（动物、植物、合成等）；（2）生产工艺风险（灭菌工艺、环境控制等）；（3）制剂应用风险（给药途径、患者群体等）。通过量化评分确定风险等级，据此制定差异化的控制策略。4.2 完善方法学研究体系应系统开展以下研究工作：（1）不同特性辅料的微生物回收率研究；（2）新型检测技术（如快速微生物检测）的适用性评估；（3）替代方法的验证研究。建议成立专门的工作组，协调产学研各方资源，加快方法学研究的进度。4.3 推动标准协调与国际化在保持标准科学性的前提下，应积极推进与欧美药典的协调工作。具体措施包括：（1）参与国际药典协调会议；（2）开展比对研究；（3）采纳经过验证的国际通用方法。这种协调既有利于提高我国标准的国际认可度，也能促进药用辅料的进出口贸易。(五)总结总的来说，通过对《中国药典》《美国药典》和《欧洲药典》药用辅料微生物控制标准的系统比较，可以看出我国在标准体系的完善性、风险管理的科学性和方法学的系统性方面仍有提升空间。未来应当从以下三个方面重点突破：首先，建立基于风险的分级管控体系，实现标准的科学差异化；其次，加强特殊辅料检测方法研究，解决实际检测难题；最后，推进标准国际化进程，提升我国药典的国际影响力。只有构建起科学、系统、开放的药用辅料标准体系，才能真正保障药品质量安全，促进医药产业高质量发展。最后，建议相关部门加大投入，组织产学研联合攻关，从而加快我国药用辅料标准与国际先进水平接轨的步伐。药事纵横投稿须知：稿费已上调，欢迎投稿