[The EMEA CHMP guidelines in coronary heart disease and chronic heart failure].
The official regulatory recommendations for drug development and the granting of marketing authorisations are intended for use by pharmaceutical companies and the regulatory agencies. These recommendations are particularly useful in Europe, and allow harmonisation of the regulatory requirements between the different member states, thus facilitating further evaluation of the submission file and the registration process. The European guidelines are issued by the Committee for Human Medicinal Products (CHMP) of the European Agency for the Evaluation of Pharmaceutical Products (EMEA). The key points of the current guidelines regarding applications for phase III trials in coronary heart disease (stable angina, acute coronary syndromes) and chronic heart failure are presented. They are as follows: the definition of selected populations, the choice of criteria for evaluating efficacy and safety, the choice of comparators, and study duration etc.
Chauvenet
Marina
M
AREMIS Consultants, Neuilly-sur-Seine, France. mchauvenet@ace-health.com
D002317:Cardiovascular Agents / Q000592:standards* / Q000627:therapeutic use*; D017326:Clinical Trials, Phase III as Topic / Q000592:standards; D003327:Coronary Disease / Q000188:drug therapy*; D017277:Drug Approval; D004345:Drug Industry; D006333:Heart Failure / Q000188:drug therapy*; D006801:Humans; D007880:Legislation, Drug; D012106:Research
D002317:Cardiovascular Agents