The ICH guidelines are covered under four headings under the acronym QSEM – Quality, Safety, Efficacy, and Multidisciplinary.
(a) Quality guidelines: These guidelines cover the
areas of quality of drug products such as impurity testing and stability
studies and a flexible approach to quality based on GMP risk management.
(b) Safety guidelines: They help to detect potential
risks such as genotoxicity, carcinogenicity, and nephrotoxicity. For example,
the ICH came up with a non-clinical test methodology to evaluate QT interval
prolongation which is probably the most significant reason why drugs have been
withdrawn in recent times.
(c) Efficacy guidelines: These guidelines provide
guidance about designing, conducting, safety aspects, and reporting of clinical
trials for pharmaceutical products. Novel drug products derived from
biotechnology and genomic/pharmacogenetic techniques for targeted drug delivery
are also covered.
(d) Multidisciplinary guidelines: Topics in the
pharmaceutical field that do not fit into any of the above categories are
covered under this area. This guideline also includes details of (MedDRA), CTD,
and standards such as Electronic Standards for the Transfer of Regulatory
Information (ESTRI)