Annotated guidance to the European Medicines Agency (EMA) guidelines and regulatory documents. A new series of the BJCP

he European Medicines Agency was established in 1995 tooversee the scientific evaluation and the safety monitoringof medicines in the European Uni on. The remit of thisEuropean agency is to ensure public and a nimal health inall member states as well as in the countries of the EuropeanEconomic Area (Norway, Iceland and Liechtenstein). Theagency does this by assurin g drug quality, safety an d efficacyfor about h alf a billion i nhabitants. The EMA is located inLondon but will m ove to the Netherlands as a result of theUK leaving the EU. The mission of the EMA can be foundon theirwebsite.Inthiseditorial,wewillgiveabriefintro-duction to the functions of t he EMA. Furt her infor mationabout the EMA m ission, stru cture and a ctivities as well as onhow it interacts with academia can be found at http://www.ema.europa.eu/ema and in the hyperlinks provided in thiseditorial.Provision of information to health care professionals is animportant function of the EMA that is perhaps not widely ap-preciated by clinical pharmacologists and others involved intherapeutics . European Pu blic Assessment Reports (E PAR)are a very rich source of info rmation on new medicines thatare available through a user-friendlysearch eng ine.EPAR'scontain all the information that led to the application formarketing a s well a s safety and quality/production data.An additional import ant informati on tool for any healthprofessional invo lved in therapeutic or pharmacologic inno-vation is the wi de rang e of subjects covered byscient ificguid elin es .EMAscientific guidelines are EU Communitydocuments that are in tended to p rovide advice to comp a-nies applying for market authorization and competentauthorities in mem ber s tates.The EMA clinical guidelines are d eveloped through a pro-cess of consultation that is transparent, so g uidelines on theEMA websi te fi rstly appear as concept papers or draft guide-lines (which enter a period of con sultation) and finally asadopted guidelines. Scie ntists from all membe r states havethe r ight to comment. We do find that these comments areoften adopted, so watching the consu ltation process is alsoof scientifi cvalue.The catalogue of guidelin es is categorized according to theCommon Technical Document (CTD) w hen t hey con-cern general issues and include the guidelines that are glob-ally harmonized through the International Council onHarmoni sati on of Techn ical Require men ts for Reg-istrat io n of Phar mac eu tica ls fo r Human U se(ICH).TheCommitteeforMedicinalProductsforHumanUse(CHMP) prepares the scientific and clinical guidelines wh ichwe will cover in this series especially. The guidelines covervirtually all therapeutic areas