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 1983—1999. He is also a founder of the Estonian Drug Regulatory Authority, the State Agency of Medicines and its first Director General 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 2001 he started the WHO Medicines Prequalification Programme, which does the regulatory assessment of products for purchase by UN-funded programmes. At WHO he led work to strengthen regulatory systems including combatting falsified medicines, and the development of pharmacovigilance and regulatory networks in Low- and Middle Income Countries. In September 2013, he was appointed as Head of the newly formed 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 one unit including development of norms and standards, safety surveillance, prequalification of medical products, and regulatory systems strengthening.
Since 2000, he has served as an observer to the International Council for Harmonization (ICH), first representing WHO and now representing Council for International Organizations of Medical Sciences (CIOMS). In 2016, he was appointed to the position of Secretary-General of CIOMS. CIOMS is very active in issuing international guidance documents in pharmacovigilance, product development and research ethics. At present CIOMS has six active working groups.