美國的醫藥品監管情報

本報告提供美國的醫藥品的製造、流通、銷售相關法規和必要條件，醫藥品的登記、更新、通知相關法規與程序，醫藥品的顯示、廣告相關法規，相關費用等彙整趨勢。

目錄

第1章 簡介

第2章 法規當局和醫藥品開發

• 法規當局的管理
• 醫藥品開發
  • OTC專著為基礎一般醫藥品的市場進入
  • CDER SBIA (CDER Small Business and Industry Assistance)
  • 申請類型
  • FDA核准
  • 醫藥品開發指定

第3章 學名藥

• 學名藥的認證流程
• 新藥簡易申請 (ANDA)

第4章 新藥申請 (NDA)

• NDA的指導文件
• 法律、法規、政策、手續
  • 聯邦規則集 (CFR)
  • CDER的政策與手續的手冊 (MaPPs)
  • 處方藥使用費法 (PDUFA)
  • NDA表格與電子提交
  • 諮詢委員會
• 對電子化的法規當局的提交與審查
  • 電子通用技術文件 (eCTD)
  • FDA電子申請閘道器 (ESG)
• 藥物回收
  • 對公共的警告
  • 周下面實施報告
  • 回收的有效性的判斷

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