Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Experiment Videos

Is ICH exportable outside the European Union?

N J Dent1

  • 1Country Consultancy Ltd., Copper Beeches, Gayton Road, Milton Malsor, Northants NN7 3AA, UK. nigeld@cwcom.net

Quality Assurance (San Diego, Calif.)
|November 17, 2001
PubMed
Summary

International Conference on Harmonisation (ICH) Good Clinical Practices (GCP) Guidelines are successfully implemented outside the European Union. Studies in countries like Poland and India demonstrate high-quality clinical trials meeting or exceeding EU standards.

Related Concept Videos

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

Can non-regulators audit Independent Ethic Committees (IEC), and if so, how?

Quality assurance (San Diego, Calif.)·2002
Same author

Essentials of quality in "the gold standard veterinary clinical trial".

Quality assurance (San Diego, Calif.)·1999
Same author

The changing role of quality assurance: an international industry perspective.

Quality assurance (San Diego, Calif.)·1995
Same author

The French GLP and GCP inspections and agencies plus an overview of GLP and GCP inspections and agencies in Eastern and Central Europe.

Quality assurance (San Diego, Calif.)·1995
Same author

The inspection of drug metabolism and pharmacokinetic studies.

Quality assurance (San Diego, Calif.)·1992
Same author

European Good Laboratory and Clinical Practices: their relevance to clinical pathology laboratories.

Quality assurance (San Diego, Calif.)·1991

Area of Science:

  • Clinical Research Standards
  • International Regulatory Compliance

Background:

  • The International Conference on Harmonisation (ICH) Good Clinical Practices (GCP) Guidelines are globally recognized.
  • Major regulatory bodies like the USA, Japan, and Europe have integrated ICH GCPs into their national legislation.

Purpose of the Study:

  • To assess the exportability and practical application of ICH GCP Guidelines outside the European Union (EU).
  • To determine if clinical trials conducted outside Western Europe can achieve the same or higher standards of quality.

Main Methods:

  • Evaluation based on a 16-center clinical study for nonseasonal rhinitis in the Czech Republic and Poland.
  • Inclusion of audit findings and comparison with other therapeutic areas and studies in non-EU countries.
  • Case study highlighting a head and neck cancer trial in India involving photodynamic therapy.

Related Experiment Videos

Main Results:

  • The clinical study in the Czech Republic and Poland demonstrated a very high standard of compliance with ICH GCPs.
  • Evidence from multiple studies indicates that clinical trial standards in non-EU countries are often equal to or higher than those within the EU.
  • High-quality clinical trials are being conducted in regions often perceived as developing countries.

Conclusions:

  • ICH GCP Guidelines are effectively exportable and implementable globally.
  • Clinical trials conducted outside the EU, including in Central/Eastern Europe and India, meet rigorous international quality standards.
  • The perception of clinical trial quality in non-EU countries needs re-evaluation, as high standards are demonstrably achievable.