Early Clinical Development Plan
Požadavky na absolvování
Zobrazit
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)
ICH M3 (R2) Non-clinical safety studies for the conduct of human clinical trials for pharmaceuticals - EMA - Preclinical Safety Evaluation of Biotechnology-derived Pharmaceuticals (ICH S6, CPMP/ICH/302/95)
ICH S6 (R1) Preclinical safety evaluation of biotechnology-derived pharmaceuticals - EMA - Non-clinical Evaluation of QT Interval Prolongation (ICH S7B, CPMP/ICH/423/02)
ICH S7B - Non-clinical Evaluation of the Potential for delayed Ventricular Repolarization (QT Interval Prolongation) - EMA - Safety Pharmacology Studies for Human Pharmaceuticals (ICH S7A, CPMP/ICH/539/00)
ICH S7A Safety pharmacology studies for human pharmaceuticals - EMA - Toxicokinetics: Assessment of Systemic Exposure in Toxicity Studies (ICH S3A, CPMP/ICH/384/95)
ICH S3A Toxicokinetics - EMA - Position Paper on Non-clinical Safety Studies to Support Clinical Trials with a Single Microdose (CPMP/SWP/2599/02)
Position Paper - IAA AMS
Clinical
- General Considerations for Clinical Trials (ICH E8, CPMP/ICH/291/95)
ICH E8 General considerations for clinical studies - EMA - Guideline on Strategies to Identify and Mitigate Risks for First-in-Human Clinical Trials (EMEA/CHMP/SWP/28367/07)
Guideline on strategies to identify and mitigate risks - EMA - Guideline for Good Clinical Practice (ICH E6, E6(R2), E6(R3))
First adopted by the EU in 1996 and most recently updated in 2025.
ICH_E6(R3)_Step4_FinalGuideline_2025_0106.pdf - Guideline on Dose Response Information to Support Drug Registration (ICH E4, CPMP/ICH/378/95)
ICH E4 Dose response information - EMA - Guideline on Studies in Support of Special Populations: Geriatrics (ICH E7, CPMP/ICH/379/95)
ICH E7 Studies in support of special populations: geriatrics - EMA - Guideline on PK of Medicinal Products in Patients with Impaired Hepatic Function (CPMP/EWP/2339/02)
Evaluation of pharmacokinetics in hepatic impairment - EMA - Guideline on PK of Medicinal Products in Patients with Decreased Renal Function (draft, EMA/83874/2014)