The Australian TGA has adopted the EU Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals (ICH M3(R2)bb). The effective date was November 5, 2010. The purpose of this document is to recommend international standards for, and promote harmonization of, the nonclinical/preclinical safety studies recommended to support human clinical trials of a given scope and duration as well as marketing authorization for pharmaceuticals. This guidance should facilitate the timely conduct of clinical trials, reduce the use of animals in accordance with the 3R (reduce/refine/replace) principles, and reduce the use of other drug development resources.
The recent approval by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) of the 7 protein biomarker panel for use in detecting drug-induced kidney damage means that the biomarkers are now qualified at the same level by all of the ICH regulatory agencies. In a Critical Path Initiative statement, this is the first biomarker qualification decision by the PMDA and means that the panel is qualified for voluntary use in nonclinical safety studies. Furthermore, data generated using the panel can be submitted to the PMDA on a case-by-case basis for use in monitoring drug-induced renal toxicity in humans. The 7 biomarker panel, composed of kidney injury molecule-1, albumin, total protein, β2-microglobulin, cystatin C, clusterin, and trefoil factor 3, can be utilized in conjuntion with the current standard renal biomarkers, serum creatine and blood-urea nitrogen. With the exception of trefoil factor 3, the PMDA stated that the new renal biomarkers outperformed the current standard biomarkers. The renal biomarker panel received approval in 2008 from the US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) for limited use in nonclinical and clinical drug development. Additional guidelines regarding biomarker qualification are expected in July 2010.
The Federal Register and the ICH S9 Guidance for the nonclinical evaluation for anticancer pharmaceuticals issued today. The guidance provides recommendations for preclinical studies for the development of pharmaceuticals, including both drugs and biotechnology derived products, intended to treat patients with advanced cancer. The recommendations describe the type and timing of preclinical studies to support an investigational new drug application (IND) and the submission of a new drug application (NDA) or biologics license application (BLA).