General Principles for the Education and Training of GCP Inspectors: The Outcome of Discussions by International Regulatory Experts in the Discussion Group on the ICH E6 Guideline

Uyama Y 1 , Yamazaki E 1 , Clark K 2 , Wang CY 3 , Woro E 4 , Tong FY 5 Show all authors , Sachidanandan S 5 , Rodriguez A 6 , Oh H 7 , Saleh K 8 , Cirunay J 9 , Wapeewuttikorn A 10 , Rogov E 11 , Alshahwan KW 12 , Herrera I 13 , Mthetwa J 14 , Fakudze F 15 , Osawa T 1

Affiliations 

  • 1 1 Pharmaceuticals and Medical Devices Agency, Tokyo, Japan
  • 2 2 Therapeutic Goods Administration, Department of Health, Woden, Australia
  • 3 3 Food and Drug Administration, Taiwan, Chinese Taipei
  • 4 4 The National Agency of Drug and Food Control, Jakarta Pusat, Indonesia
  • 5 5 Health Sciences Authority, Singapore
  • 6 6 European Medicines Agency, London, UK
  • 7 7 Ministry of Food and Drug Safety, Cheongju, Korea
  • 8 8 National Pharmaceutical Control Bureau, Ministry of Health Selangor Darul Ehsan, Malaysia
  • 9 9 Food and Drug Administration, Muntinlupa City, Philippines
  • 10 10 Food and Drug Administration, Nonthaburi, Thailand
  • 11 11 Federal Service on Surveillance in Healthcare and Social Development (Roszdravnadzor), Moscow, Russia
  • 12 12 Saudi Food and Drug Authority, Riyadh, Saudi Arabia
  • 13 13 Ministry of Health, San José, Costa Rica
  • 14 14 Southern African Development Community Secretariat, Gaborone, Botswana
  • 15 15 Ministry of Health, Matsapha, Swaziland
Ther Innov Regul Sci, 2015 Mar;49(2):249-253.
PMID: 30222411 DOI: 10.1177/2168479014551646

Abstract

In response to the globalization of drug development, regulatory inspection of Good Clinical Practice (GCP) has recently been conducted not only by International Conference on Harmonisation (ICH) regions but also non-ICH regions. To promote the international implementation of GCP, consistent understanding and interpretation of its concept among regions are important. This article summarizes the background and past activities of the E6 Discussion Group, established under the Regulators Forum.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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