Table 1 Guideline documents from regulatory bodies on pharmaceuticals in general
Guideline/Text | Origin/Organization | Topic | References |
|---|---|---|---|
ICH M3(R2): “Non-clinical safety studies for the conduct of human clinical trials and marketing authorisation for pharmaceuticals” | ICH (EMA, FDA) | General requirements on non-clinical safety studies | Anonymous (2009) |
ICH S9: “Nonclinical evaluation for anticancer pharmaceuticals” | ICH (EMA, FDA) | Anticancer Pharmaceuticals | Anonymous (2010) |
ICH S7A: “Note for guidance on safety pharmacology studies for human pharmaceuticals” | ICH (EMA, FDA) | General requirements on non-clinical safety studies | Anonymous (2001) |
ICH S6(R1): “Preclinical safety evaluation of biotechnology-derived pharmaceuticals” | ICH (EMA, FDA) | Biotech pharmaceuticals | Anonymous (2011) |
CHMP/SWP/28367/07: “Guideline on strategies to identify and mitigate risks for first in human and early clinical trials with investigational medicinal products” | EMA | General requirements on non-clinical safety studies | Anonymous (2018) |
Directive 2001/83/EU “Community code relating to medicinal products for human use” | EU | “Pharmaceutical Directive” Requirements for toxicological and pharmacological studies | Directive (2001) |
Directive 2010/63/EU on the protection of animals used for scientific purposes | EU | Animal welfare and protection | Directive (2010) |
Directive 2004/2010/EC “Good laboratory practice: tests on chemical substances” | EU | GLP requirements | Directive (2004) |
FDA/ICH Guidance Document: “Guidance For Industry, Co-development of Two or More New Investigational Drugs for Use in Combination” | FDA/ICH | Investigational Drugs | Research C for DE and. Codevelopment of Two or More New Investigational Drugs for Use in Combination [Internet] (2020) |
FDA/ICH Guidance Document: “Redbook 2000:IV.B.1 General Guidelines for Designing and Conducting Toxicity Studies” | FDA/ICH | Toxicity Studies | Nutrition and for FS and A. Redbook (2000) |
FDA/ICH Guidance Document: “Guidance for Industry, Investigators, and Reviewers: Exploratory IND Studies” | FDA/ICH | Exploratory investigational new drug (IND) studies | Research C for DE and. Exploratory IND Studies [Internet]. U.S. Food and Drug Administration (2019) |