十八、GUIDANCE DOCUMENT: Requests for Rec**ideration at the Division Level Under GDUFA
Content current as of: 01/10/2024
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled “Requests for Rec**ideration at the Division Level Under GDUFA.” This draft guidance provides recommendati** on the procedures for applicants of abbreviated new drug applicati** (ANDAs) that wish to pursue a request for rec**ideration within the review discipline at the division level or original signatory authority.
十九、GUIDANCE DOCUMENT: ANDA Submissi** – Amendments and Requests for Final Approval to Tentatively Approved ANDAs
Content current as of: 01/23/2024
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “ANDA Submissi** - Amendments and Requests for Final Approval to Tentatively Approved ANDAs.” This guidance is intended to assist applicants in preparing and submitting amendments to tentatively approved abbreviated new drug applicati** (ANDAs), including requests for final approval.
二十、GUIDANCE DOCUMENT: Revising ANDA Labeling Following Revision of the RLD Labeling Guidance for Industry
Content current as of: 01/24/2024
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Revising ANDA Labeling Following Revision of the RLD Labeling.” This guidance provides recommendati** for updating labeling for abbreviated new drug applicati** (ANDAs) following revisi** to the labeling of a reference listed drug (RLD), including information on how to identify RLD labeling updates and how to submit labeling updates to both unapproved and approved ANDAs to conform to RLD labeling updates.
二十一、GUIDANCE DOCUMENT: Conducting Remote Regulatory Assessments Questi** and Answers
Content current as of: 02/02/2024
The Food and Drug Administration (FDA or Agency) is announcing the availability for comment of a revised draft guidance for industry entitled “Conducting Remote Regulatory Assessments - Question and Answers.” FDA has revised and is reissuing the draft guidance in resp**e to public comments and recent amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act). When finalized, this guidance will describe FDA's current thinking regarding its use of remote regulatory assessments (RRAs).
十四、GUIDANCE DOCUMENT：Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act
Content current as of: 02/26/2024
The Food and Drug Administration (FDA) is issuing this guidance to assist registrants of drug establishments in submitting reports to FDA on the amount of each listed drug manufactured, prepared, propagated, compounded, or processed for commercial distribution, as required by section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360(j)(3)), as added by section 3112(e) of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act).
十五、Biologics License Applicati** and Master Files (Final Rule)
Content current as of: 02/12/2024
The Food and Drug Administration (FDA) is issuing a final rule to amend its regulati** to address the use of master files by applicati** licensed under the Public Health Service Act (PHS Act). The final rule codifies FDA’s existing approach that former approved applicati** for certain biological products under the Federal Food, Drug, and Cosmetic Act (FD&C Act) that have been deemed to be licenses for the biological products under the PHS Act may continue to incorporate by reference drug substance, drug substance intermediate, or drug product (DS/DSI/DP) information contained in a drug master file (DMF) if such information was being referenced at the time the application was deemed to be a license. This final rule also codifies FDA's general practices regarding the referencing of information in master files by applicati** licensed under the PHS Act, including applicati** for combination products licensed under the PHS Act, and by investigational new drug applicati** (INDs) for products that would be subject to licensure under the PHS Act.
十六、FDA Approves First Cellular Therapy to Treat Patients with Unresectable or Metastatic Melanoma
Content current as of: 02/16/2024
Today, the U.S. Food and Drug Administration approved Amtagvi (lifileucel), the first cellular therapy indicated for the treatment of adult patients with a type of skin cancer (melanoma) that is unable to be removed with surgery (unresectable) or has spread to other parts of the body (metastatic) that previously has been treated with other therapies (a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor).
十七、Clinical Pharmacology C**iderati** for Antibody-Drug Conjugates Guidance for Industry
Content current as of: 02/28/2024
This guidance provides recommendati** to assist industry and other parties involved in the development of antibody-drug conjugates (ADCs) with a cytotoxic small-molecule drug or payload. Specifically, this guidance addresses the FDA’s current thinking regarding clinical pharmacology c**iderati** and recommendati** for bioanalytical methods, dosing strategies, dose- and exposure-resp**e analysis, intrinsic factors, QTc assessments, immunogenicity, and drug-drug interacti** (DDIs). The principles discussed in this guidance might not be applicable to the development of other types of ADCs (e.g., ADCs with payloads other than cytotoxic small molecule drugs and/or for indicati** other than oncology).
十、Drug Quality, Current Good Manufacturing Practice Inspecti** and Compliance
发布时间：2024年3月15日
FDA works to ensure the medicati** that are available to hospitals, health systems and patients are safe, effective and of high quality. For application products, typically prescription drugs, FDA’s approval process is the first step. FDA’s drug application approval includes assessing the manufacturing process and the facility, including information the agency gained through inspecti** or alternative tools, to ensure the proposed manufacturing process can be performed in compliance with applicable standards and produce high-qualityExternal Link Disclaimer drugs.
In addition, FDA oversees the safety and quality of medicati** that are not marketed under an approved application, including over-the-counter monograph and compounded drugs.
十一、Handling and Retention of Bioavailability BA and Bioequivalence BE Testing Samples
发布时间：2024年3月26日
This guidance is intended to provide recommendati** for applicants of new drug applicati** (NDAs) and abbreviated new drug applicati** (ANDAs), including supplemental applicati**, and contract research organizati** (CROs), regarding the procedures for handling reserve samples from relevant bioavailability (BA) and bioequivalence (BE) studies, as required by §§ 320.38 and 320.63 (21 CFR 320.38 and 320.63), and recommendati** regarding 21 resp**ibilities of each ** involved in the study pertaining to reserve samples. In the context of §§ 320.38 and 320.63, the term applicant includes, as appropriate, study sp**or and/or drug manufacturer and the term CRO refers to any ** contracted to help conduct BA or BE testing, including, as appropriate, site management organizati** (SMOs), investigators, and testing sites.
十二、Providing Regulatory Submissi** in Electronic Format: IND Safety Reports Guidance for Industry
发布时间：2024年3月29日
FDA is announcing the availability of a final guidance for industry entitled “Providing Regulatory Submissi** in Electronic Format: IND Safety Reports.” This guidance finalizes the draft guidance of the same name published on October 30, 2019 (84 FR 58158), and describes the electronic format sp**ors will be required to use when they electronically submit IND safety reports to CDER and CBER for serious and unexpected suspected adverse reacti**, as required under 21 CFR 312.32(c)(1)(i). FDA is establishing the electronic format requirements described in this final guidance under section 745A(a) of the FD&C Act (21 U.S.C. 379k-1(a)).
九、Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies Guidance for Industry
发布时间：2024年4月1日
This guidance provides instructi** for the electronic submission of expedited individual case safety reports (ICSRs) from investigational new drug (IND)-exempt bioavailability (BA)/bioequivalence (BE) studies conducted to support abbreviated new drug applicati** (ANDAs)2 to FDA Adverse Event Reporting System (FAERS). An ICSR captures information necessary to support the reporting of an adverse event related to an individual subject that is associated with the use of an FDA-regulated product.3 The electronic submission of the ICSRs from IND-exempt BA/BE studies is a voluntary option for submitting these required reports.
十、Data Integrity for In Vivo Bioavailability and Bioequivalence Studies
发布时间：2024年4月2日
The purpose of this guidance is to provide recommendati** to applicants and testing site management on achieving and maintaining data integrity for the clinical and bioanalytical porti** of bioavailability (BA) and bioequivalence (BE) studies submitted in support of investigational new drug applicati** (INDs), new drug applicati** (NDAs), and abbreviated new drug applicati** (ANDAs), and the bioanalytical portion of clinical pharmacologic studies supporting CDER-regulated biologic license applicati** (BLAs) as well as amendments and supplements to these applicati**. In addition, the recommendati** in this guidance apply to the bioanalytical portion of nonclinical studies. FDA also encourages applicants and testing sites to c**ider these recommendati** when conducting other studies, including in vitro and pharmacology and toxicology studies.
十一、WHO GMP for excipients used in pharmaceutical products - Appendix 1: Risk Management in the production and control of excipients used in pharmaceutical products (QAS/24.945)
十二、WHO GMP for excipients used in pharmaceutical products - Appendix 2: List of examples of high-risk excipients (QAS/24.944)
十三、WHO good manufacturing practices c**iderati** for the prevention and control of nitrosamine con**ination in pharmaceutical products (QAS/24.943)
The use of human- and animal-derived materials to manufacture cellular and gene therapy (CGT) products and tissue-engineered medical products (TEMPs) raises several key issues to c**ider, including transmission of adventitious agents, material lot-to-lot c**istency, and material identity, as well as general material qualification c**iderati**. We, FDA, are providing you, manufacturers of CGT and TEMP products, with recommendati** regarding assuring the safety, quality, and identity of materials of human and animal origin used in the manufacture of these products. In addition, recommendati** are provided regarding the chemistry, manufacturing, and control (CMC) information submitted in an investigational new drug application (IND) relating to the use of human- and animal-derived materials.
Allogeneic cells of human origin may be expanded in culture to manufacture medical products c**isting of live cells, inactivated cells, cell lysates, or other cell-based materials such as cell-derived particles. We, FDA, are providing you, sp**ors of allogeneic cell-based medical products, recommendati** for determining the appropriate cell safety testing to support an Investigational New Drug Application (IND) or a Biologics License Application (BLA). Cell safety testing should be based on a risk analysis that c**iders the expansion potential of the cells, the reagents that are used to expand the cells in culture, and the number of individuals the cell-based medical product is capable of treating.
This guidance provides details about the implementation of the platform technology designation program established by section 506K of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This guidance outlines eligibility factors for receiving a platform technology designation, potential benefits of receiving a designation, how to leverage data from designated platform technologies, how to discuss a planned designation request as part of a milestone meeting, the recommended content of a designation request submission, and the review timelines for a designation request. This program is intended to result in efficiencies in drug development, manufacturing, and review processes for drug product applicati** that incorporate designated platform technologies.
This guideline provides recommendati** to promote a c**istent approach in designing, conducting, and interpreting enzyme- or transporter-mediated in vitro and clinical drug-drug interaction (DDI) studies during the development of a therapeutic product. A c**istent approach will reduce uncertainty for the pharmaceutical industry to meet the requirements of multiple regulatory agencies and lead to more efficient utilization of resources. In addition, this approach will lead to the effective and safe treatment for patients who take multiple medicati**.
The purpose of this document is to recommend international standards for, and promote harmonization of, the general principles on planning, designing, and analyzing observational (non-interventional) pharmacoepidemiological studies that utilize fit-for-purpose data for safety assessment of medicines (drugs, vaccines, and other biological products).
正文链接：
[url=国家药品监督管理局NMPA 一、国家药监局综合司公开征求《关于发布境内生产药品再注册申报程序和申报资料要求的通告》意见 发布时间：2024年5月13日 为贯彻实施新修订《药品管理法》《疫苗管理法》《药品管理法实施条例》《药品注册管理办法》等法律法规规章文件，落实药品审评审批制度改革要求，完善药品注册体系，加强药品再注册管理，服务、推动医药产业高质量发展，国家药监局组织拟定《关于发布境内生产药品再注册申报程序和申报资料要求的通告（征求意见稿）》。现向社会公开征求意见。 相关附件： 1.关于发布境内生产药品再注册申报程序和申报资料要求的通告（征求意见稿） 2.反馈意见表 正文链接： https://www.nmpa.gov.cn/xxgk/zhqyj/zhqyjyp/20240513180809143.html 二、关于公开征求《已在境内上市的境外生产药品转移至境内生产的药品上市注册申请申报资料要求（预防用生物制品）（征求意见稿）》意见的通知 发布时间：2024年5月15日 为贯彻落实国务院《关于进一步优化外商投资环境加大吸引外资投资力度的意见》的要求，指导和支持已在境内上市的境外生产药品转移至境内生产的预防用生物制品上市注册申请申报工作，细化落实《药品上市后变更管理办法（试行）》文件要求，我中心起草了《已在境内上市的境外生产药品转移至境内生产的药品上市注册申请申报资料要求（预防用生物制品）（征求意见稿）》，现通过中心网站公示并征求意见。 相关附件： 1、《申报资料要求(预防用生物制品)(征求意见稿)》.pdf 2、《申报资料要求(预防用生物制品)(征求意见稿)》起草说明.pdf 3、《已在境内上市的境外生产药品转移至境内生产的药品上市注册申请申报资料要求(预防用生物制品)(征求意见稿)》征求意见反馈表.docx 正文链接： https://www.cde.org.cn/main/news ... 63bcf4cd6c964fee8a0 三、国家药监局关于适用《Q2（R2）：分析方法验证》《Q14：分析方法开发》国际人用药品注册技术协调会指导原则的公告 发布时间：2024年5月28日 为推动药品注册技术标准与国际接轨，经研究，国家药品监督管理局决定适用《Q2（R2）：分析方法验证》《Q14：分析方法开发》国际人用药品注册技术协调会指导原则（以下简称Q2（R2）/Q14）。现就有关事项公告如下： 1、申请人需在现行药学研究技术要求基础上，按照Q2（R2）/Q14指导原则的要求开展研究；自2024年11月24日开始的相关研究（以试验记录时间点为准），均适用Q2（R2）/Q14指导原则。 2、Q14提供了两种开发方式，申请人可以自行选择基础（即传统）方式或者增强方式，也可以选择部分采用增强方式。 3、Q14涉及分析方法全生命周期与变更管理，可能有同时涉及到Q12的相关内容，如既定条件（EC）。申请人如提交同时涉及到Q12相关内容的注册申请，请同时执行Q12适用公告要求。 4、相关技术指导原则可在国家药品监督管理局药品审评中心网站查询。国家药品监督管理局药品审评中心负责做好本公告实施过程中的相关技术指导工作。 正文链接： https://www.nmpa.gov.cn/xxgk/ggt ... 40528100619111.html 美国食品药品监督管理局FDA 四、在细胞和基因治疗以及组织工程医疗产品制造中使用人类和动物源性材料的注意事项 发布时间：2024年5月15日 The use of human- and animal-derived materials to manufacture cellular and gene therapy (CGT) products and tissue-engineered medical products (TEMPs) raises several key issues to c**ider, including transmission of adventitious agents, material lot-to-lot c**istency, and material identity, as well as general material qualification c**iderati**. We, FDA, are providing you, manufacturers of CGT and TEMP products, with recommendati** regarding assuring the safety, quality, and identity of materials of human and animal origin used in the manufacture of these products. In addition, recommendati** are provided regarding the chemistry, manufacturing, and control (CMC) information submitted in an investigational new drug application (IND) relating to the use of human- and animal-derived materials. 正文链接： https://www.fda.gov/regulatory-i ... -therapy-and-tissue 五、人类同种异体细胞的安全性测试扩展到基于细胞的医疗产品中 发布时间：2024年5月15日 Allogeneic cells of human origin may be expanded in culture to manufacture medical products c**isting of live cells, inactivated cells, cell lysates, or other cell-based materials such as cell-derived particles. We, FDA, are providing you, sp**ors of allogeneic cell-based medical products, recommendati** for determining the appropriate cell safety testing to support an Investigational New Drug Application (IND) or a Biologics License Application (BLA). Cell safety testing should be based on a risk analysis that c**iders the expansion potential of the cells, the reagents that are used to expand the cells in culture, and the number of individuals the cell-based medical product is capable of treating. 正文链接： https://www.fda.gov/regulatory-i ... ed-medical-products 六、药物研发平台技术认定计划 发布时间：2024年5月28日 This guidance provides details about the implementation of the platform technology designation program established by section 506K of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This guidance outlines eligibility factors for receiving a platform technology designation, potential benefits of receiving a designation, how to leverage data from designated platform technologies, how to discuss a planned designation request as part of a milestone meeting, the recommended content of a designation request submission, and the review timelines for a designation request. This program is intended to result in efficiencies in drug development, manufacturing, and review processes for drug product applicati** that incorporate designated platform technologies. 正文链接： https://www.fda.gov/regulatory-i ... am-drug-development 人用药品技术要求国际协调理事会ICH 七、M12 药物相互作用研究 发布时间：2024年5月21日 ICH M12 Guideline This guideline provides recommendati** to promote a c**istent approach in designing, conducting, and interpreting enzyme- or transporter-mediated in vitro and clinical drug-drug interaction (DDI) studies during the development of a therapeutic product. A c**istent approach will reduce uncertainty for the pharmaceutical industry to meet the requirements of multiple regulatory agencies and lead to more efficient utilization of resources. In addition, this approach will lead to the effective and safe treatment for patients who take multiple medicati**. 正文链接： https://database.ich.org/sites/d ... ine_2024_0521_0.pdf 八、M12 指南：药物相互作用研究 - 问答 发布时间：2024年5月21日 ICH M12 Guideline: DRUG INTERACTION STUDIES, Questi** and Answers 正文链接： https://database.ich.org/sites/d ... %26As_2023_0521.pdf 九、M14 使用真实世界数据进行药品安全性评估的药物流行病学研究的计划、设计和分析的一般原则 发布时间：2024年5月21日 The purpose of this document is to recommend international standards for, and promote harmonization of, the general principles on planning, designing, and analyzing observational (non-interventional) pharmacoepidemiological studies that utilize fit-for-purpose data for safety assessment of medicines (drugs, vaccines, and other biological products). 正文链接： https://database.ich.org/sites/d ... eline_2024_0521.pdf]https://database.ich.org/sites/default/files/ICH_M14_Step3_DraftGuideline_2024_0521.pdf[/url]
2024年1-2月最全的GMP法规指南更新汇总
01 国外法规指南对于国外的法规指南，我们将按照发布机构来划分。ICH1. Post-ApprovalL Safety Data: Definiti** and Standards for Management and Reporting of Individual Case Safety Reports E2D(R1) (Draft)E2D(R1) 批准后安全性数据：个例安全性报告管理和报告的定义和标准（草案）发布时间：2024/02/12征求意见截止时间（中国区）：2024/05/12FDA1. Generic Drug User Fee Amendments (GDUFA) Science and Research Priority Initiatives for Fiscal Year (FY) 20242024财年根据仿制药使用者付费法案（GDUFA）科学和研究优先计划发布时间：2024/01/082. 2023 Office of Compliance Annual Report2023年合规性办公室年报发布时间：2024/01/113. ANDA Labeling Following Revision of the RLD LabelingRLD 标签修订之后的ANDA 标签发布时间：2024/01/244. ANDA Submissi** – Amendments and Requests for Final Approval to Tentatively Approved ANDAsANDA 申报 — 暂时批准 ANDAs 的最终批准增补和请求发布时间：2024/01/245. Best Practices for FDA Staff in the Postmarketing Safety Surveillance of Human Drug and Biological ProductsFDA工作人员对药品和生物制品上市后安全性监督的最佳实践指南发布时间：2024/01/266. C**iderati** for the Development of Chimeric Antigen Receptor (CAR) T Cell Products嵌合抗原受体（CAR）T 细胞产品的研发考量发布时间：2024/01/297. Human Gene Therapy Products Incorporating Human Genome Editing包含人类基因组编辑的人类基因治疗产品发布时间：2024/01/298. Medical Devices; Quality System Regulation Amendments医疗器械质量管理体系法规最终规章发布时间：2024/02/029. Biologics License Applicati** and Master Files生物制品许可申请和主文件发布时间：2024/02/1210. Use of Data Monitoring Committees in Clinical Trials临床试验中数据监查委员会的使用发布时间：2024/02/12 EMA1. EU Updated the Sterile Medicinal Products part of Guidance on GMP and GDP: Questi** and Answers欧盟更新了《GMP和GDP问答》的无菌附录部分发布时间：2024/02/122. Concept Paper for the Development of a Guideline on Non-Inferiority and Equivalence Comparis** in Clinical Trials (Draft)临床试验中非劣效性比较和等效性比较指南(草案)发布时间：2024/02/16征求意见截止时间：2024/05/31Swissmedic1. Authorisation of Human Medicinal Product with Known Active Pharmaceutical Ingredient含有已知活性成分的人用药的许可指南发布时间：2024/01/152. Temporary Authorisation to use an Unauthorised Medicinal Product人用药的临时许可指南发布时间：2024/01/1502 国内法规指南对于国内的法规指南，德恩根据法规指南、指南/标准、公告/指令来分类。指南/标准1.《药品网络交易第三方平台检查指南（试行）》发布时间：2024/01/052.《治疗用重组蛋白产品临床试验申请病毒清除工艺平台验证技术指导原则（试行）》发布时间：2024/01/163.《抗肿瘤药物说明书安全性信息撰写技术指导原则》发布时间：2024/01/164.《放射性标记人体物质平衡研究技术指导原则》发布时间：2024/01/165.《药物免疫毒性非临床研究技术指导原则》发布时间：2024/01/186.《人源干细胞产品非临床研究技术指导原则》发布时间：2024/01/187.《间充质干细胞防治移植物抗宿主病临床试验技术指导原则》《罕见病基因治疗产品临床试验技术指导原则》发布时间：2024/01/188.《放射性治疗药物非临床研究技术指导原则》发布时间：2024/01/249.《药物临床试验机构年度工作总结报告填报指南》发布时间：2024/01/2510.《2023年度药品审评报告》发布时间：2024/02/0411.《化学药改良型新药临床药理学研究技术指导原则（试行）》发布时间：2024/02/0412.《2023年度医疗器械注册工作报告》发布时间：2024/02/0513.《放射性化学仿制药药学研究技术指导原则》发布时间：2024/02/0514.《药品注册研发生产主体合规信息管理与审查指导原则（试行）》发布时间：2024/02/0515.《药物研发与技术审评沟通交流会议申请资料参考》发布时间：2024/02/0716.《微型片剂（化学药品）药学研究技术指导原则（试行）》发布时间：2024/02/0817. YY 1001—2024《全玻璃注射器》等20项医疗器械行业标准发布时间：2024/02/1918.《输液容器生物负载控制指南》发布时间：2024/02/20征求意见稿截止时间：2024/03/2019.《低分子量肝素类仿制药药学研究与评价技术指导原则（试行）》发布时间：2024/02/2220.《罕见病酶替代疗法药物非临床研究指导原则（试行）》发布时间：2024/02/2321. ①《中药制剂特征图谱研究技术指导原则（试行）》②《中药制剂稳定性研究技术指导原则（试行）》发布时间：2024/02/27 公告/指令1. 关于境外生产药品证明文件有关事宜的通知发布时间：2024/01/232.国家药监局关于印发优化药品补充申请审评审批程序改革试点工作方案的通知发布时间：2024/02/073. 国家药监局药审中心关于在中国上市药品专利信息登记平台设置法律文书提交模块的通知发布时间：2024/02/264. 关于更新电子申报资料制作软件的通知发布时间：2024/02/282024年3-5月最全的GMP法规指南更新汇总1. 国外法规指南
对于国外的法规指南，我们将按照发布机构来划分。
WHO
1. GMP for Excipients Used in Pharmaceutical Products - Appendix 1: Risk Management in the Production and Control of Excipients Used in Pharmaceutical Products (Draft)
药用辅料 GMP — 附件1 ：药用辅料生产和控制的风险管理（草案）
发布时间：2024/04/12
征求意见稿截止时间：2024/06/09
2. Good Manufacturing Practices C**iderati** for the Prevention and Control of Nitrosamine Con**ination in Pharmaceutical Products (Draft)
预防和控制药品中亚硝胺污染的 GMP 考量（草案）
发布时间：2024/04/12
征求意见稿截止时间：2024/06/09
ICH
1. M12 Drug Interaction Studies (Final)
M12 药物相互作用研究指南（最终版本）
发布时间：2024/05/12
FDA
1. Clinical Pharmacology C**iderati** for Antibody-Drug Conjugates (Draft)
抗体偶联药物的临床药理学考量（草案）
发布时间：2024/03/28
2. Data Integrity for In Vivo Bioavailability and Bioequivalence Studies
体内生物利用度和生物等效性研究的数据可靠性
发布时间：2024/04/01
征求意见稿截止时间：2024/06/01
3. Real-World Evidence: C**iderati** Regarding Non-Interventional Studies for Drug and Biological Products (Draft)
真实世界证据：关于药品和生物制品非干预性研究的考虑（草案）
发布时间：2024/04/08
征求意见稿截止时间：2024/07/08
4. Laboratory Developed Test
实验室自研检测
发布时间：2024/04/29
5. Content and Format of Composition Statement and Corresponding Statement of Ingredients in Labeling in NDAs and ANDAs (Draft)
NDA 和 ANDA 中组成声明和相应标签成分声明的内容和格式（草案）
发布时间：2024/04/29
征求意见稿截止时间：2024/06/29
6. 2023 Office of New Drugs Annual Report
2023 年新药办公室年度报告
发布时间：2024/04/29
7. Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products
人类同种异体细胞扩增用于基于细胞的医药产品的安全性检测
发布时间：2024/04/30
8. C**iderati** for the use of human - and animal-derived materials in the production of cell and gene therapy and tissue engineered medical products (Draft)
细胞和基因治疗以及组织工程医疗产品生产中使用人源和动物源材料的考量（草案）
发布时间：2024/04/30
9. REMS Logic Model: A Framework to Link Program Design With Assessment (Draft)
REMS 逻辑模型：将项目设计与评价相联系的框架（草案）
发布时间：2024/05/07
征求意见稿截止时间：2024/08/07
10. Medical device remanufacturing
医疗器械再制造
发布时间：2024/05/09
征求意见稿截止时间：2024/08/09
11. FY 2023 GDUFA Science and Research Report
2023财年GDUFA科学与研究报告
发布时间：2024/05/23
12. Platform Technology Designation Program for Drug Development (Draft)
药物研发平台技术认定计划（草案）
发布时间：2024/05/29
征求意见稿截止时间：2024/07/09
EMA
1. Guideline on Quality, Non-clinical and Clinical Requirements for Investigational Advanced Therapy Medicinal Products in Clinical Trials - Scientific Guideline (Draft)
临床试验中研究用先进疗法药品的质量、非临床和临床要求指南（草案）
发布时间：2024/03/25
征求意见稿截止时间：2024/05/31
2. Pharmaceutical Quality of Inhalation and Nasal Products - Scientific Guideline (Draft)
吸入制剂和鼻用制剂药品质量指南（草案）
发布时间：2024/04/12
征求意见截止时间：2024/10/31
3. Guideline on the Requirements for Dem**trating Therapeutic Equivalence between Orally Inhaled Products (OIP) for Asthma and Chronic Obstructive Pulmonary Disease (COPD)
证明用于哮喘和慢性阻塞性肺病（COPD）的经口吸入制剂（OIP）治疗等效性的要求的指南
发布时间：2024/04/12
征求意见截止时间：2024/10/31
MHRA
1. Impact of AI on the Regulation of Medical Products
人工智能（AI）对医药产品监管的影响
发布时间：2024/04/30
2. 国内法规指南
对于国内的法规指南，gempex德恩咨询根据法规指南、指南/标准、公告/指令来分类。
法规指南
1.《化妆品检查管理办法》
发布时间：2024/04/19
实施时间：2024/11/01
2.《地区性民间习用药材管理办法》
发布时间：2024/05/14
实施时间：2024/11/01
指南/标准
1.ICH E2D（R1）《上市后安全数据：个例安全报告管理和报告的定义和标准》
发布时间：2024/03/13
实施时间：2024/05/12
2.《国家药品不良反应监测年度报告（2023年）》
发布时间：2024/03/26
3.《化学药品3类注册申请药学自评估报告》
发布时间：2024/04/02
征求意见稿截止时间：2024/05/03
4.《化学仿制药生物等效性研究摘要》
发布时间：2024/04/11
5.《药审中心关于已上市药品说明书增加儿童用药信息工作细则（试行）》
发布时间：2024/04/18
6.《化妆品注册人、备案人收集和报告化妆品不良反应指南（试行）》
发布时间：2024/04/19
7.《按古代经典名方目录管理的中药复方制剂药学申报资料撰写指导原则（试行）》
发布时间：2024/04/22
8.《已上市境外生产药品转移至境内生产的药品上市注册申请申报资料要求（化学药品）》
发布时间：2024/05/09
9.《非处方药适应症范围确定原则》
发布时间：2024/05/10
征求意见稿截止时间：2024/06/12
10.《体外诊断试剂分类目录》
发布时间：2024/05/11
11.《已在境内上市的境外生产药品转移至境内生产的药品上市注册申请申报资料要求（预防用生物制品）》
发布时间：2024/05/15
征求意见稿截止时间：2024/06/16
12.《中药改良型新药研究技术指导原则（试行）》
发布时间：2024/05/15
13.《处方药转换为非处方药申请范围指导原则》
发布时间：2024/05/20
征求意见稿截止时间：2024/06/22
公告/指令
1. 关于进一步加强医疗器械注册人委托生产监督管理的公告
发布时间：2024/04/03
2. 关于进一步做好药品经营监督管理有关工作的公告
发布时间：2024/04/22
3. 关于发布优化化妆品安全评估管理若干措施的公告
发布时间：2024/04/22
4. 关于优化已在境内上市的境外生产药品转移至境内生产的药品上市注册申请相关事项的公告
发布时间：2024/04/23
5. 关于实施《体外诊断试剂分类目录》有关事项的通告
发布时间：2024/05/11