Lembit Rägo MD, PhD was born in Tartu, Estonia, in 1955. From 1992 to 1999, he was Professor of Clinical Pharmacology at Tartu University. He was the founder and first Director General of the Estonian regulator, the State Agency of Medicines (1991-1999). In December 1999, he joined the WHO Headquarters in Geneva. During 2000-2001, Dr Rägo laid the foundation for the WHO Prequalification of Medicines Programme. Since then the Programme has been the key to getting quality medicines to millions of HIV/AIDS, malaria and tuberculosis patients in developing countries. During his stay in WHO he was also actively involved in creating norms and standards, strengthening regulatory systems and pharmacovigilance. From September 2013, Dr Rägo served as Director and Head of WHO’s newly formed big unit, Regulation of Medicines and Other Health Technologies (RHT), which for the first time in WHO history combined all regulatory issues related to medicines, biologicals including vaccines, and medical devices, into one single unit. In April 2016 he was appointed Secretary-General of Council for International Organizations of Medical Sciences (CIOMS, located in Geneva, Switzerland). Today CIOMS runs many different technical Working Groups related to medical products development, safety and bioethics.