EMEA: Concept paper on the Need to update the Note for guidance on clinical investigation of medicinal products in the treatment of lipid disorders (CPMP/EWP/3020/03) and the Note for guidance on the clinical investigation on medicinal products in the tre

Current CHMP recommendations for the clinical development of lipid lowering and blood pressure (BP) lowering agents accept the possibility of drug registration for the so called biological indications. This means that the basis for the demonstration of the efficacy of these drugs can be their effect on biological markers (LDL-cholesterol and BP respectively).