美国的医药品监管情报

本报告提供美国的医药品的製造、流通、销售相关法规和必要条件，医药品的登记、更新、通知相关法规与程序，医药品的显示、广告相关法规，相关费用等彙整趋势。

目录

第1章 简介

第2章 法规当局和医药品开发

• 法规当局的管理
• 医药品开发
  • OTC专着为基础一般医药品的市场进入
  • CDER SBIA (CDER Small Business and Industry Assistance)
  • 申请类型
  • FDA核准
  • 医药品开发指定

第3章 学名药

• 学名药的认证流程
• 新药简易申请 (ANDA)

第4章 新药申请 (NDA)

• NDA的指导文件
• 法律、法规、政策、手续
  • 联邦规则集 (CFR)
  • CDER的政策与手续的手册 (MaPPs)
  • 处方药使用费法 (PDUFA)
  • NDA表格与电子提交
  • 咨询委员会
• 对电子化的法规当局的提交与审查
  • 电子通用技术文件 (eCTD)
  • FDA电子申请闸道器 (ESG)
• 药物回收
  • 对公共的警告
  • 周下面实施报告
  • 回收的有效性的判断

Highlights:

This report presents an understanding of the regulations and requirements of companies in the U.S., as well as foreign companies or establishments planning to manufacture, distribute or market their pharmaceuticals in the U.S. This report provides a brief about the related regulations for registration of the establishments and pharmaceuticals.

Report Scope:

The current report provides detailed exposure to regulatory requirements for pharmaceuticals marketing and registration in the USA. This report highlights the current regulations and comprehensive procedure for the registration, renewal, or notification of the pharmaceuticals, along with the information on the timeline and fee required. The report also focuses on the labeling and advertising regulations for the pharmaceutical and the process for the registration of the product with any specific variation. These regulations would be helpful for the premarketing of the pharmaceutical in the U.S. market.

Report Includes:

• A brief general outlook of the current market scenario of regulatory requirements for pharmaceuticals marketing and registration in the U.S.
• Highlights of the current regulations and comprehensive procedure for the registration, renewal, or notification of the pharmaceuticals, along with the information on the timeline and fee required
• Emphasis on the labeling and advertising regulations for the pharmaceutical and the process for the registration of the product with any specific variation
• Coverage of the technological, economic, and business considerations of pharmaceuticals regulatory scenario and premarketing of the pharmaceutical in the U.S. market

Table of Contents

Chapter 1 Introduction

• 1.1 Study Goals and Objectives
• 1.2 Scope of Report
• 1.3 Information Sources
• 1.4 Analyst's Credentials
• 1.5 Related BCC Research Reports

Chapter 2 Governing Authority and Drug Development

• 2.1 Governing Regulatory Authority
• 2.2 Drug Development
  • 2.2.1 Market Entry of Nonprescription Drug Products Under OTC Monograph
  • 2.2.2 CDER Small Business and Industry Assistance (CDER SBIA)
  • 2.2.3 Application Types
  • 2.2.4 FDA Approval
  • 2.2.5 Drug Development Designations

Chapter 3 Generic Drugs

• 3.1 Approval Process for Generic Drugs
• 3.2 Abbreviated New Drug Application (ANDA)

Chapter 4 New Drug Application (NDA)

• 4.1 Guidance Documents for NDAs
• 4.2 Laws, Regulations, Policies and Procedures
  • 4.2.1 Code of Federal Regulations (CFR)
  • 4.2.2 CDER's Manual of Policies and Procedures (MaPPs)
  • 4.2.3 Prescription Drug User Fee Act (PDUFA)
  • 4.2.4 NDA Forms and Electronic Submissions
  • 4.2.5 Advisory Committees
• 4.3 Electronic Regulatory Submissions and Review
  • 4.3.1 Electronic Common Technical Document (eCTD)
  • 4.3.2 FDA Electronic Submissions Gateway (ESG)
• 4.4 Drug Recalls
  • 4.4.1 Alerting the Public
  • 4.4.2 Weekly Enforcement Report
  • 4.4.3 Determining the Effectiveness of the Recall