Lembit Rägo, MD, PhD
Dr. Lembit Rägo graduated Tartu University in Estonia as a medical doctor in 1979. During 1991-1999 he was Professor of Clinical Pharmacology at Tartu University and also the founder and first Director General of the Estonian Drug Regulatory Authority, State Agency of Medicines. He has two PhD degrees in medicine (one from Tartu University, Estonia, and another from Kuopio University, Finland).
In December 1999, he joined World Health Organization (WHO) Headquarters, Geneva, as Coordinator of Quality Assurance and Safety: Medicines team which included activities related to International Nonproprietary Names, Quality Assurance, Pharmacovigilance, Regulatory Support and Fighting Falsified Medicines. During 2000—2001, Dr Rägo laid the foundations for the WHO Prequalification of Medicines Programme and has continued to contribute to its development ever since. In 2004 he initiated extremely successful rotational fellows programme allowing regulators from Low and Middle Income Countries (LMICs) work in WHO prequalification for three months and take the obtained knowledge, expertise and experience back to their home institutions. Since 2002, he has been the main organizer of WHO biennial International Conference of Drug Regulatory Authorities (ICDRA) bringing together regulators from around 100 countries all over the World.
From September 2013, Dr Rägo served as the Head of WHO’s newly formed unit, Regulation of Medicines and Other Health Technologies, consisting of four teams covering technical norms and standards, safety and vigilance, prequalification (assessment of products quality, safety and efficacy) and regulatory systems strengthening for medicines, vaccines and diagnostics. This unit of more than 125 staff is a key unit determining WHO’s policy on regulatory systems strengthening which includes a very wide range of activities from policies to actual scientific assessment of products. It also worked on written and physical standards through WHO Expert Committee on Specifications of Pharmaceutical Preparations and WHO Expert Committee on Biological Standardization. Additionally, the unit includes WHO assessment tool for national regulatory systems and is one of the biggest training providers on various regulatory issues for LIMICs. Under his leadership the unit established confidentiality arrangements with major regulators such as US FDA and EU European Medicines Agency (EMA).
Since 2000, he has been a WHO observer to the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Steering Committee , ICH Global Cooperation Group, International Pharmaceutical Regulators Forum and International Coalition of Medicines Regulatory Authorities. He is also the participant of Heads of Agencies Summits – an informal gathering of leading Global regulators such as EU EMA, US FDA, Japanese PMDA, Health Canada, Chinese CFDA and Brazilian ANVISA. He also has served as a member of the Uppsala Monitoring Centre Board and was responsible for publishing WHO Drug Information quarterly journal since 2000.
He is well known to many senior regulators, is a frequent speaker in different international fora and has numerous publications including on several aspects of regulatory affairs. After leaving WHO in April 2016 Dr Lembit Rägo started to work as new Secretary-General of the Council of International Organizations of Medical Sciences (CIOMS).