吹皱一池春水,2018年中美欧法规进展展望

Advertising广告

Presenting Quantitative Information in Direct-to-Consumer Promotional Labeling and Advertisements

直接面对消费者宣传标签和广告的量化信息呈现

Updating Promotional Materials to Reflect Labeling Changes to Risk Information

更新宣传材料反映出风险信息的标签变化

Clinical/Antimicrobial临床/抗菌

Cytomegalovirus in Transplantation: Developing Drugs for Treatment and Prevention

移植中的巨细胞病毒：治疗和预防用药物的开发

Smallpox (Variola Virus) Infection: Developing Drugs for Treatment and Prevention;Revised Draft

天花（天花病毒）感染：治疗和预防用药物的开发；修订草案

Streamlining Pediatric HIV Antiretroviral Drug Development Intended for Global Use

用于全球精简儿童HIV抗逆转录病毒　药物的开发

Uncomplicated Urinary Tract Infections: Developing Antimicrobial Drugs for Treatment

非复杂性尿路感染：治疗用抗菌药物的开发

Clinical/Medical临床/医学

Amyotrophic Lateral Sclerosis: Developing Drugs for Treatment

肌萎缩性侧索硬化症：治疗用药物的开发

Antiepileptic Drugs for Treatment of Partial Onset Seizures: Full Extrapolation of Efficacy from Adult to Pediatrics Patients 4 Years of Age and Older

治疗部分发作性癫痫的抗癫痫药物：对成人和4岁及以上儿科患者疗效的全面推断

Early Alzheimer’s Disease: Developing Drugs for Treatment

早期阿尔茨海默氏病：治疗用药物的开发

Hypertension: Developing Fixed-Dose Combination Drugs for Treatment

高血压：治疗用固定剂量联合用药的开发

Migraine: Developing Drugs for Treatment

偏头痛：治疗用药物的开发

Opioid Dependence: Developing Depot ** Products for Treatment

阿　片类药物依赖：治疗用丁丙诺　啡产品的开发

Pediatric Oncology Product Development; Revised Draft

儿科肿瘤学产品开发；修订草案

Pregnant Women in Clinical Trials – Scientific and Ethical Considerations

临床试验中的孕妇—科学和伦理考虑

Pregnancy, Prevention and Planning: Recommendations for Pregnancy Testing and Contraception for Drugs with Teratogenic Potential

怀孕、预防和计划：对具有致畸潜能的药物进行妊娠试验和避孕的建议

Clinical Pharmacology临床药理

Assessing the Effects of Food on Drugs in INDs or NDAs – General Considerations

评估食物对研究用新药或新药申请中药品的影响—总则

 Bioavailability Studies Submitted in NDAs for INDs – General Considerations

新药申请中研究用新药生物利用度研究的提交–总则

Clinical Drug Interactions Studies: Study, Design, Data Analysis, Implications for Dosing and Labeling Recommendations, Revised Draft

临床药物相互作用研究：研究，设计，数据分析，给药和标签推荐的影响，修订草案

General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products

药物和生物制品新生儿研究的一般临床药理学考虑

In Vitro Metabolism-and-Transporter -Mediated Drug-Drug Interaction Studies; Revised Draft

体外代谢与转运蛋白介导的药物相互作用研究；修订草案

Pharmacokinetics in Patients with Impaired Renal Function – Study Design, Data Analysis and Impact on Dosing and Labeling; Revised Draft

肾功能损害患者的药代动力学-研究设计、数据分析及剂量和标签的影响；修订草案

Pharmacokinetics in Patients with Impaired Hepatic Function – Study Design, Data Analysis and Impact on Dosing and Labeling

肝功能受损患者的药代动力学--研究设计、数据分析及剂量和标签的影响

Pharmacogenomic Data Submission

药物基因组学数据提交

Clinical/Statistical临床/统计

Adaptive Design Clinical Trials for Drugs and Biologics; Revised Draft

药品和生物制品临床试验的适应性设计；修订草案

Adjusting for Covariates in Randomized Experiments

随机实验中协变量的调整

Meta-Analysis of Randomized Controlled Clinical Trials to Evaluate the Safety of Human Drugs or Biologic Products

人用药品或生物制品安全性评估的随机对照试验的Meta分析

Drug Development Tools新药研发工具

Biomarker Qualification: Evidentiary Framework; Draft Guidance for Industry and FDA Staff

生物标志物的确认：证据框架；对行业与FDA工作人员的指南草案

Drug Safety药品安全

Postmarketing Safety Reporting for Human Drugs and Biological Products Including Vaccines, Revised Draft

人用药品、生物制品包括**的上市后安全报告，修订草案

Restricted Delivery Systems: Flow Restrictors and Oral Liquid Drug Products

限制给药系统：剂量受控以及口服液制剂

Electronic Submissions电子申报

Standardized Format for Electronic Submissions of NDA and BLA Content for the Planning and Conduct of Bioresearch Monitoring Inspections for CDER Submissions

NDA和BLA用于计划执行生物学研究监测检查的电子申报的标准化格式

Providing Regulatory Submissions in Electronic Format – Drug

以电子格式规范提交—药品

Establishment Registration and Drug Listing

建立登记和药品目录

Providing Regulatory Submissions in Electronic Format – Bioanalytical Methods Data Standards

以电子格式规范提交—生物分析方法数据标准

Providing Regulatory Submissions in Electronic Format – Standardized Bioanalytical Data

以电子格式规范提交—标准化的生物分析数据

Generics仿制药

180-Day Exclusivity: Questions and Answers

180天市场独占期：问答

Assessing Adhesion for ANDAs with Transdermal Delivery Systems and Topical Patches; Revised Draft

ANDAs 对透皮给药系统和外用贴剂粘附性的评价，修订草案

Assessing Irritation and Sensitization Potentials of Generic Transdermal and Topical Patches Submitted in ANDAs

ANDAS中提交的一般经皮给药和外用贴剂的刺激和致敏电位评价

Bioequivalence Studies with Pharmacokinetic Endpoints for Drug Products Submitted in ANDAs; Revised Draft

ANDA中药品具有药代动力学终点的生物等效性研究的提交；修订草案

Failure to Timely Respond to an ANDA CR Letter

ANDA中受控通信（CR）的未及时回复

Referencing Approved Drug Products in ANDA Submissions; Revised Draft

ANDA提交中的参比药品；修订草案

Sameness Under the 505(j) Pathway

按照505(j)路径的一致性

Therapeutic Equivalence – General Considerations

治疗等效性-总则

Three-Year Exclusivity Determinations for Drug Products

药品三年独占期判定

Variations in Drug Products (ANDAs) Guidance

ANDAs药品指南的变化

Labeling标签

Drug Abuse and Dependence Section of Labeling for Human Prescription Drug and Biological Products – Content and Format

人用处方药品和生物制品标签，药品滥用和依赖部分—内容和格式

Indications and Usage Section of Labeling for Human Prescription Drugs and Biological Products – Content and Format

人用处方药和生物制品标签，适应症和使用部分—内容和格式

Instructions for Use for Human Prescription Drug and Biological Products – Content and Format

人用处方药和生物制品的使用说明—内容和格式

Labeling for Combined Hormonal Contraceptives

联合激素避孕药的标签

Pregnancy, Lactation and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products; Revised Draft

人用处方药和生物制品标签，怀孕哺乳以及生殖潜能；修订草案

Product Title and Initial U.S. Approval in the Highlights of Prescribing Information for Human Prescription Drug and Biological Products – Content and Format

人用处方药和生物制品中产品名称以及最初美国批准的处方信息的警示语-内容和格式

Recommended Statement for Over-the-Counter (OTC) Aspirin-Containing Drug

Products Labeled with Cardiovascular-Related Imagery Guidance for Industry

非处方药中标有心血管相关影像行业指南的含阿司匹林药品的推荐声明

Over-The-Counter 非处方药OTC

Innovative Approaches for Nonprescription Drug Products

非处方药的创新方法

Maximal Usage Trial for Topical Active Ingredients Being Considered in the Over-the-Counter Monograph: Study Elements and Considerations

非处方专著中应考虑的外用活性成分的使用量试验：研究内容和考虑因素

Pharmaceutical Quality/Microbiology药品质量/微生物学

Microbiological Considerations for Non-Sterile Drug Products

非无菌药品微生物考虑点

Pharmaceutical Quality/CMC药品质量/CMC

CDER’s Program for the Recognition of Voluntary Consensus Standards

CDER承认自愿协商一致标准的程序

Clarification of Human Drug Application Establishment Information Q&A Guidance

澄清人用药物申请场所信息问答的指南

Drug Master Files; Revised Draft Version: 19 January 2018

DMF；修订草案2018年1月19日

Harmonizing Compendial Standards with Drug Application CMC Approval

Requirements Using the USP Pending Monograph Process

协调药典标准与与药品申请CMC批准要求采用USP征求意见稿的流程

Identification of Manufacturing Establishments in Applicants Submitted to CBER and CDER – Questions and Answers

提交给CBER和CDER的申请中生产场所的识别-问答

In-vitro Methods for Evaluation of Abuse Deterrent Properties of Opioid Products

阿　片类药物滥用抑制特性的体外评价方法

Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products – Chemistry,Manufacturing, and Controls Documentation; Revised Draft

计量吸入器（MDI）和干粉吸入器（DPI）的药品-化学，制造和控制文件；修订草案

Post-Approval Changes to Drug Substances (GDUFAII)

批准后的变更原料药(GDUFAII)

Product Development and Quality Control of Transdermal and Related Delivery Systems

经皮给药及相关给药系统的产品开发和质量控制

Quality Considerations for Continuous Manufacturing (CM)

连续生产(CM)的质量考虑点

Type V Drug Master File (DMF) for Combination Products with CDER Jurisdiction Utilizing a Device Part with Electronics or Software

CDER管辖的利用电子或软件的设备部件组合产品的V类DMF

Use of Liquids and/or Soft-Foods as Vehicles for Drug Administration: General Considerations for Selection and In Vitro Methods for Product Quality Assessments

使用液体和/或软性食品给药：产品质量评估的选择和体外方法的一般考虑

Using the Inactive Ingredient Database

非活性成分数据库的使用

Pharmaceutical Quality/Manufacturing Standards (CGMP) 药品质量/制造标准（CGMP）

CGMP Final Interim Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act; Revised Draft

根据FD&C法案503B部分人用药品配制外包设施的CGMP最终临时指南；修订草案

Field Alert Report Submission

区域警示报告提交

Pharmacology/Toxicology药理/毒理学

Nonclinical Safety Evaluation of Ophthalmic Pharmaceuticals

眼科药物非临床安全性评估

Procedural程序

Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act

根据《联邦食品、药品和化妆品法》第505（q）条诉讼中止的公民请愿和诉讼

Civil Monetary Penalties for Failure to Meet Accelerated Post Marketing Requirements

未能满足加速上市后需求的民事罚款

Content of Threshold Analyses and Human Factors Submissions to an NDA, BLA or ANDA

提交一份NDA, BLA 或ANDA的阈值分析和人为因素的内容

Definitions of Suspect Product and Illegitimate Product or Verification Obligations

可疑产品和非法产品或核查义务的定义

Designated Delivery Services for 505(b)(2) or ANDA Applicants Sending Notices of Paragraph IV Patent Certification

505(b)(2)或ANDA申请发送第IV部分专利认定通知的指定的运送服务

Development of a Shared System REMS

共用系统缓解策略（REMS）的开发

Good Review Management Principles and Practices for PDUFA and BsUFA Products

PDUFA 和 BsUFA产品的良好审评管理原则和实践

Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier

对无产品标识的产品包装和统一的过渡政策

Implementation of the “Deemed to be a License” Provision of the BPCI Act: Questions and Answers

实施BPCI法案中“视为许可”的规定：问答

Pediatric Product Development Under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act: Scientific Considerations; Revised Draft

根据儿科研究公平法案和儿童药物法案进行儿科产品开发：科学考虑点；修订草案

Pediatric Product Development Under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act: Regulatory Considerations; Revised Draft

根据儿科研究公平法案和儿童药物法案进行儿科产品开发：法规监管考虑点；修订草案

Proposed Accreditation Program Under the Drug Supply Chain Security Act

Version: 19 January 2018

根据药品供应链安全法案拟定认证方案 版本：2018年1月19日

Proposed Licensing Program Under the Drug Supply Chain Security Act

根据药品供应链安全法案撰写许可程序

Public Disclosure of FDA-Sponsored Studies

FDA发起研究的公开披露

Qualified Infectious Disease Product Designation: Questions and Answers

传染病产品认定的确认：问答

REMS Assessment: Planning and Reporting

缓解策略（REMS）评估：计划和报告

Standardization of Data and Documentation Practices for Product Tracing

产品跟踪的数据和文件操作的标准化

Streamlined Submission Process to Determine Whether an Investigational In Vitro

精简提交程序以确定是否进行体外研究

Companion Diagnostic in an Oncology Trial is Significant Risk

肿瘤学试验中进行同伴诊断颇具风险

Survey Methodologies to Assess REMS Goals Related to Knowledge

评估缓解策略（REMS）目标关于知识方面的调查方法

The Product Identifier for Human, Finished, Prescription Drugs: Question and Answers

人用处方药成品：问答

Use of a Drug Master File for Shared System Risk Evaluation and Mitigation Strategies(REMS)

共用系统风险评估和缓解策略（REMS）采用DMF

Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs

根据食品供应链安全法对某些处方药的核查系统

Waivers, Exceptions and Exemptions from the Requirements of Section 582 of the Federal Food, Drug and Cosmetic Act

联邦食品，药品和化妆品法案582部分要求的豁免和例外

Waivers of the Single, Shared System REMS Requirement

单一，共用系统缓解策略（REMS）要求 的豁免

Rare Diseases罕见病

Rare Diseases: Early Drug Development and the Role of Pre-IND Meetings

罕见疾病：早期药物开发和前期会议的作用

Rare Diseases: Common Issues in Drug Development

罕见病：药物开发中的常见问题

User Fees用户付费

Prescription Drug User Fee Act Waivers for Fixed Dose Combination Antiretroviral Drugs for the President’s Emergency Plan for AIDS Relief

处方药用户付费法案中对抗艾滋用总统紧急救援计划中的固定剂量联合抗逆转录病毒　药物的豁免

Prescription Drug User Fee Act Waivers, Reductions, and Refunds for Drug and Biological Products

处方药用户付费法案豁免，减少以及药品和生物制品退款

New EU Guidelines新欧盟指南

GMP Guide: Annex 21 (Importation of medicinal products)

GMP指南：附录21（药品进口）

GMP and Marketing Authorisation Holders

GMP和上市许可持有人

Guideline on the sterilisation of the medicinal product, active substance, excipient and primary container, EMA/CHMP/CVMP/QWP/BWP/850374/2015 (H/V)

对药品、活性物质、辅料以及主要容器灭菌的指南EMA/CHMP/CVMP/QWP/BWP/850374/2015 (H/V)

EU Guidelines under revision欧盟修订指南

GMP Guide: Introductions

GMP指南：简介

GMP Guide: Chapter 1 (Pharmaceutical Quality System)

GMP指南：第一章（制工经质量体系）

GMP Guide: Chapter 4 (Documentation)

GMP指南：第四章（文件）

GMP Guide: Annex 1 (Manufacture of Sterile Medicinal Products)

GMP指南：附录1（无菌药品的制造）

GMP Guide: Annex 11 (Computerised Systems)

GMP指南：附录11（计算机化系统）

Guideline on the manufacture of the finished dosage form (V)

成品生产的指南(V)

Guideline on quality of water for pharmaceutical use (H+V)

制药用水质量指南(H+V)

ICH Guidelines ICH指南

ICH Q12 (Lifecycle Management)

ICH Q12生命周期管理

Other guidance其它指南

Q&As on the implementation of the updated shared facilities guidance

关于更新共用设施指南实施的问答