Early Clinical Development Plan

6. Applicable regulatory guidelines (optional)

The EMA provides a number of guidelines on Non-Clinical and Clinical development.

The main guidelines related to early clinical development are the following.

Non-clinical

  • Non-Clinical Safety Studies For The Conduct Of Human Clinical Trials For Pharmaceuticals (ICH M3), CPMP/ICH/286/95: here

  • Preclinical safety evaluation of biotechnology-derived pharmaceuticals (ICH S6) CPMP/ICH/302/95: here

  • The Non-clinical Evaluation of the Potential for delayed Ventricular Repolarisation (QT Interval Prolongation) by Human Pharmaceuticals (ICH S7B) CPMP/ICH/423/02: here

  • Safety pharmacology studies for human pharmaceuticals (ICH S7A)- CPMP/ICH/539/00: here

  • Position Paper on the non-clinical safety studies to support clinical trials with a single microdose (CPMP/SWP/2599/02): here

Clinical
  • General Considerations for Clinical Trials, (ICH E8) CPMP/ICH/291/95: here
  • Guideline on strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicinal products. EMEA/CHMP/SWP/28367/07: here
  • Public consultation currently underway on E6 (R2): here

  • Guideline on Dose response information to support drug registration (ICH E4), CPMP/ICH/378/95: here
  • Guideline on studies in support of special populations: geriatrics (ICH E7) CPMP/ICH/379/95: here
  • Guideline on PK of medicinal products in patients with impaired hepatic function CPMP/EWP/2339/02: here
  • Guideline on PK of medicinal products in patients with decreased renal function (draft) EMA/83874/2014: here
  • Guideline on Clinical evaluation of QT/QTc interval prolongation (ICH E14): here

  • Ethical considerations for clinical trials on medicinal products conducted with the paediatric population(233 KB) (2008)