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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. Available at: ICH M3 (R2) Non-clinical safety studies for the conduct of human clinical trials for pharmaceuticals - Scientific guideline | European Medicines Agency (europa.eu)
- Preclinical safety evaluation of biotechnology-derived pharmaceuticals (ICH S6) CPMP/ICH/302/95: ICH S6 (R1) Preclinical safety evaluation of biotechnology-derived pharmaceuticals - Scientific guideline | European Medicines Agency (europa.eu)
- The Non-clinical Evaluation of the Potential for delayed Ventricular Repolarisation (QT Interval Prolongation) by Human Pharmaceuticals (ICH S7B) CPMP/ICH/423/02 Available at:: S 7 B The nonclinical Evaluation of the Potential for delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals (europa.eu)
- Safety pharmacology studies for human pharmaceuticals (ICH S7A)- CPMP/ICH/539/00 Available at:: ICH S7A Safety pharmacology studies for human pharmaceuticals - Scientific guideline | European Medicines Agency (europa.eu)
- Toxicokinetics: the assessment of systemic exposure in toxicity studies (ICH S3A) -CPMP/ICH/384/95 Available at:: ICH S3A Toxicokinetics: the assessment of systemic exposure in toxicity studies - questions and answers - Scientific guideline | European Medicines Agency (europa.eu)
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Position Paper on the non-clinical safety studies to support clinical trials with a single microdose (CPMP/SWP/2599/02) Available at: Position Paper on Non-clinical safety studies to support clinical trials with a single microdose (iaa-ams.co.jp)
Clinical
- General Considerations for Clinical Trials, (ICH E8) CPMP/ICH/291/95 Available at: ICH E8 General considerations for clinical studies - Scientific guideline | European Medicines Agency (europa.eu)
- Guideline on strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicinal products. EMEA/CHMP/SWP/28367/07 Available at: Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products (europa.eu)
- E6. Guideline for Good Clinical Practice. Available at E6 (R2) and (R3) at: ICH Official web site : ICH
- Guideline on Dose response information to support drug registration (ICH E4), CPMP/ICH/378/95: Available at: ICH E4 Dose response information to support drug registration - Scientific guideline | European Medicines Agency (europa.eu)
- Guideline on studies in support of special populations: geriatrics (ICH E7) CPMP/ICH/379/95. Available at: ICH E7 Studies in support of special populations: geriatrics - Scientific guideline | European Medicines Agency (europa.eu)
- Guideline on PK of medicinal products in patients with impaired hepatic function CPMP/EWP/2339/02. Available at: Evaluation of the pharmacokinetics of medicinal products in patients with impaired hepatic function - Scientific guideline | European Medicines Agency (europa.eu)
- Guideline on PK of medicinal products in patients with decreased renal function (draft) EMA/83874/2014. Available at: Evaluation of the pharmacokinetics of medicinal products in patients with decreased renal function - Scientific guideline | European Medicines Agency (europa.eu)
- Guideline on Clinical evaluation of QT/QTc interval prolongation (ICH E14). Available at: ICH E14 Clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs - Scientific guideline | European Medicines Agency (europa.eu)
- Ethical considerations for clinical trials on medicinal products conducted with the paediatric population(233 KB) (2008)