Regulations & Guidances current as of :

(GCP-4) good clinical practice

Conducting Pharmaceutical and Medical Device Clinical Research in the European Union (EU)

Additional EU/EEC Regulations and Guidances
  • 90/385/ EEC Council Directive Relating to Active Implantable Medical Devices
  • 93/42/EEC Concerning Medical Devices
  • EU 2005/28 EC GCP Guidelines for Investigational Medicinal Products for Human Use; Requirements for Authorisation to Manufacture or Import Such Products
  • EU 536/2014 On Clinical Trials On Medicinal Products For Human Use, and Repealing Directive 2001/20/EC
  • The WMA Declaration of Helsinki (October 2013)
ICH guidelines (as included in the us code for federal regulations)
  • Clinical Safety Data Management: Definitions and Standards for Expedited Reporting
  • development safety update report e2f
  • Integrated Addendum to Good Clinical Practice
  • General Considerations for Clinical Trials