Normativos de referência comunitários


Declaração de Helsínquia - Ethical Principles for Medical Research Involving Human Subjects


  • CPMP/ICH/135/95 - Note for Guidance on Good Clinical Practice
  • CPMP/ICH/379/95 - Note for Guidance on Studies in Support of Special Populations: Geriatrics
  • CPMP/ICH/291/95 - Note for Guidance on General Considerations for Clinical Trials
  • CPMP/ICH/363/96 - Note for Guidance on Statistical Principles for Clinical Trials
  • CPMP/ICH/364/96 - Note for Guidance on Choice of Control Group in Clinical Trials
  • CPMP/ICH/2711/99 - Note for Guidance on Clinical Investigation of Medicinal Products in the Paediatric Population
  • CPMP/ICH/137/95 - Note for Guidance on Structure and Content of Clinical Study Reports
  • CPMP/ICH/378/95 - Note for Guidance on Dose Response Information to Support Drug Registration
  • EMA/CHMP/ICH/309348/2008- ICH guideline E2F Note for guidance on development safety update reports
  • CPMP/ICH/375/95 - Note for Guidance on Population Exposure: The Extent of Population Exposure to Assess Clinical Safety
  • CPMP/ICH/377/95 - Note for Guidance on Clinical Safety Data Management: Definitions and Standards for Expedited Reporting
  • EMA/CHMP/ICH/287/1995 - ICH guideline E2B (R3) on electronic transmission of individual case safety reports (ICSRs) - data elements and message specification - implementation guide
  • CPMP/ICH/289/95 - Note for Guidance on Ethical Factors in the Acceptability of Foreign Clinical Data
  • Questions and answers - (CPMP/ICH/289/95)
  • EMA/CPMP/ICH/286/1995 - ICH guideline M3(R2) on non-clinical safety studies for the conduct of human clinical trials and marketing authorisation for pharmaceuticals

Na seguinte página da Agência Europeia do Medicamento (EMA) podem ser consultadas todas as guidelines ICH e as restantes guidelines disponibilizadas pela EMA:

Scientific guidelines