The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use which we simply refer as ICH is a distinct in getting together the various "regulatory authorities and pharmaceutical industry" of Japan, Europe and US to discuss about various scientific and technical requirements of drug registration. In general ICH topic is divided into 4 major categories. 1. Quality 2. Safety 3. Efficacy 4. Multidisciplinary Quality guidelines: These include * Stability studies * Analytical Validation * Specifications * GMP risk management * Quality risk management * Impurity profile etc Safety guidelines: These include * Carcinogenicity studies * Genotoxicity studies * Toxicokinetics and Pharmacokinetics * Reproductive Toxicity * Immunotoxicology studies * Non clinical evaluation for Anticancer pharmaceuticals * Photosafety evaluation etc Efficacy guidelines: These include * Clinical safety * Dose response studies * Ethnic factors * Good clinical practice * Clinical trials * Clinical evaluation * Pharmacogenomics etc Multidisciplinary: These include * Common Technical Document (CTD) * Non clinical safety studies * Gene therapy * Genotoxic impurities * MedDRA Terminology THIS BLOG IS FREE OF PLAGIARISM Ref: http://www.ich.org/products/guidelines.html accessed on Nov 30th 2011.