Lembit Rägo, MD, PhD, graduated from the Medical Faculty of Tartu University (Estonia) in 1979. He was Professor of Pharmacology and Clinical Pharmacology at Tartu University from 1983-1999. He is also a founder of the Estonian Drug Regulatory Authority, the State Agency of Medicines and its first Director General from 1991-1999.
In December 1999 he joined the World Health Organization (WHO) Headquarters in Geneva as Coordinator of the Quality Assurance and Safety of Medicines (QSM) team. In September 2013 he was appointed as Head of the newly formed big WHO unit for Regulation of Medicines and Other Health Technologies, which –for the first time in WHO history- combined all regulatory activities for medicines, vaccines and diagnostics in the organization.
Since 2000 he has served as an observer to the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), first representing WHO and now representing Council for International Organizations of Medical Sciences (CIOMS). In 2016 he was elected to the position of Secretary-General of CIOMS that is very active in issuing international guidance documents in pharmacovigilance, product development and research ethics. At present CIOMS has seven active working groups.