[Translation and introduction of Guide to Methodological Standards in Pharmacoepidemiology]

Post-marketing pharmacovigilance of drugs has become one of the most important activities for regulatory authorities. In China, pharmacovigilance is currently receiving the attention of government, pharmaceutical industries and the public. In order to support high quality pharmacoepidemiological studies and to stimulate innovation that benefits patients and the wider public, the European medicines agency (EMA) organized the European network of centres for pharmacoepidemiology and pharmacovigilance (ENCePP) to formulate and publish the Guide on Methodological Standards in Pharmacoepidemiology as a reference document for the methodological standards of pharmacovigilance activities in the European union (EU). It supplies methodological and scientific guidance, and advises on technical aspects of conducting parmacoepidemiological studies and undertaking parmacovigilance. As advice includes: legal and ethical requirements, general aspects of study protocols, research questions, approaches to data collection, study designs and methods, statistical and epidemiological analysis plans, quality control and quality assurance, reporting of adverse events to regulatory authorities, communication of findings, and so on. The translation and introduction of this guidance can provide a useful technical and methodological reference for us to carry out the pharmacovigilance (especially for parenterally administered Chinese medicine safety monitoring).