市場調査レポート
商品コード
1147802

米国の医薬品レギュラトリーインテリジェンス

Regulatory Intelligence Report for Pharmaceuticals in the U.S.

出版日: | 発行: BCC Research | ページ情報: 英文 15 Pages | 納期: 即納可能 即納可能とは

価格
価格表記: USDを日本円(税抜)に換算
本日の銀行送金レート: 1USD=152.41円
米国の医薬品レギュラトリーインテリジェンス
出版日: 2022年10月28日
発行: BCC Research
ページ情報: 英文 15 Pages
納期: 即納可能 即納可能とは
  • 全表示
  • 概要
  • 目次
概要

本レポートでは、米国での医薬品の製造・流通・販売に関する規制や要件、医薬品の登録・更新・通知に関する規制と手順、医薬品の表示・広告に関する規制、関連費用などの動向をまとめています。

目次

第1章 イントロダクション

第2章 規制当局と医薬品開発

  • 規制当局の管理
  • 医薬品開発
    • OTCモノグラフに基づく一般医薬品の市場参入
    • CDER SBIA (CDER Small Business and Industry Assistance)
    • 申請タイプ
    • FDA承認
    • 医薬品開発指定

第3章 ジェネリック医薬品

  • ジェネリック医薬品の承認プロセス
  • 新薬簡易申請 (ANDA)

第4章 新薬申請 (NDA)

  • NDAのガイダンス文書
  • 法律・規制・政策・手続き
    • 連邦規則集 (CFR)
    • CDERのポリシーと手続きのマニュアル (MaPPs)
    • 処方薬使用料法 (PDUFA)
    • NDAフォームと電子提出
    • 諮問委員会
  • 電子的な規制当局への提出と審査
    • 電子共通技術文書 (eCTD)
    • FDA電子申請ゲートウェイ (ESG)
  • 薬物リコール
    • 公衆への警告
    • 週次施行レポート
    • リコールの有効性の判断
目次
Product Code: PHM267A

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