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International Regulationsadmin2024-09-21T00:25:04-04:00

International Regulations

Canada

  • Tri-Council Policy Statement: Ethical Conduct of Research Involving Human Subjects – 2010

European Commission

  • CE Marking
    • CE Marking of In-Vitro Diagnostic Devices
  • EU Legislation Governing Pharmaceuticals
  • General Data Protection Regulation (GDPR) – April 26, 2016 (effective date May 25, 2018)
  • Pharmaceutical Legislation Medicinal Products for Human Use – Directives and Regulations

European Medicines Agency

  • Procedures for Marketing Authorisation – April 2006
  • Publication and Access to Clinical-Trial Data (Draft) – June 2013
  • Regulatory and Procedural Guidance Index

International Conference on Harmonization (ICH)

  • ICH Guidelines E1 – E16
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