시장보고서
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1147802

미국의 의약품용 규제 정보

Regulatory Intelligence Report for Pharmaceuticals in the U.S.

발행일: | 리서치사: BCC Research | 페이지 정보: 영문 15 Pages | 배송안내 : 즉시배송

※ 본 상품은 영문 자료로 한글과 영문 목차에 불일치하는 내용이 있을 경우 영문을 우선합니다. 정확한 검토를 위해 영문목차를 참고해주시기 바랍니다.

미국에서 의약품의 제조·유통·판매에 관한 규제 및 요건, 의약품의 등록·갱신·통지에 관한 규제와 절차, 의약품의 표시·광고에 관한 규제, 관련 비용 등의 동향을 정리하여 전해드립니다.

목차

제1장 서론

제2장 규제기관과 의약품 개발

  • 규제기관의 관리
  • 의약품 개발
    • OTC 모노그래프에 기반한 일반 의약품의 시장 참여
    • CDER SBIA(CDER Small Business and Industry Assistance)
    • 신청 유형
    • FDA 승인
    • 의약품 개발 지정

제3장 제네릭 의약품

  • 제네릭 의약품의 승인 프로세스
  • 신약 간이 신청(ANDA)

제4장 신약 신청(NDA)

  • NDA의 가이던스 문서
  • 법률·규제·정책·절차
    • 연방 규칙집(CFR)
    • CDER 정책과 절차의 매뉴얼(MaPPs)
    • 처방약사용료법(PDUFA)
    • NDA 폼과 전자 제출
    • 자문위원회
  • 전자적 규제기관 제출과 심사
    • 전자 공통 기술 문서(eCTD)
    • FDA 전자 신청 게이트웨이(ESG)
  • 약물 리콜
    • 공중에 대한 경고
    • 주차 시행 리포트
    • 리콜의 유효성 판단
KSA 22.11.17

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
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