Dr. Lincoln Tsang, formerly a senior regulator qualified as a lawyer, and a pharmacist with post-graduate training in toxicology and cancer pharmacology, concentrates his practice on regulatory, compliance, enforcement and public policy matters affecting the life sciences industry: pharmaceuticals, biotechnology, medical devices, in vitro diagnostic devices, cosmetics and food. Dr. Tsang has extensive experience in advising clients in developing strategies for research and development, product life-cycle management, product acquisition, and risk and crisis management, as well as internal investigations. He regularly represents clients before various regulatory bodies on matters concerning approval, advertising and promotion, manufacture, vigilance, product recall and health technology appraisal for medicines and medical devices.

Experience

  • A senior official of the UK Regulatory Authority for nearly 13 years and head of biotechnology and biologicals, taking a leading role in developing a number of UK and European policies governing medicines regulation.
  • An advisor to the European Medicines Agency, European Directorate for the Quality of Medicines, and the European Commission, including memberships and chairmanships on a number of advisory groups.
  • An advisor to the World Health Organization concerning international trade of biological products, and most recently assisted the Council of Europe as its special advisor in developing its international convention against counterfeits.
  • Appointed by Ministers as a Commissioner for the British Pharmacopoeia; Chair of Biological and Biotechnology Specialist Group and Vice Chair of the Nomenclature Committee.
  • Nonexecutive member of the UK Health Protection Agency's Regulatory Oversight Committee.

  • Member of the UK Ministerial Industry Strategy Group.
  • Nonexecutive Director on the board of the National Institute for Biological Standards and Control.

Perspectives

European Court considers role of Concerned Member States
BioSlice Blog
The Tricky Business of Balancing Public Health Interests with Timely Authorization of Generics
Pink Sheet
Update on transparency of clinical data
BioSlice Blog
Practical Guide to the New EU Medical Devices Framework: Are You Prepared?
Arnold & Porter Kaye Scholer Webinar
Webinar: Practice Guide To The New EU Medical Devices Framework: Are You Prepared?
Digital Health Download
More

Recognition

Chambers Global
Life Sciences: Regulatory/Compliance (Global-wide) (2009-2017)
Chambers Europe
Regulatory & Public Affairs (Europe-wide) (2017)
Chambers UK
Life Sciences: Regulatory – Band 1 (UK-wide) (2012-2018)
More

Credentials

Education
  • LLB, University of London, 1994
  • PhD, Toxicology and Cancer Pharmacology, University of Aston in Birmingham, 1989
  • BPharm, Pharmacy, University of London, 1985
Admissions
  • England and Wales
Government and Military Service
  • Nonexecutive Director, Board of National Institute for Biological Standards and Control (by ministerial appointment) (2003-2010)
  • Commissioner, British Pharmacopoeia Commission
  • Vice Chairman, Nomenclature Committee, British Pharmacopoeia Commission
  • Chairman, Biological and Biotechnology Specialist Group, British Pharmacopoeia Commission

  • Head of Biologicals and Biotechnology, UK Regulatory Authority
  • Member, UK Ministerial Industry Strategy Group Sub-group Forum
Activities
  • Chair, Regulatory Affairs Advisory Committee, BioIndustry Association (2003-2010)

  • Member, Governing Council of the School of Pharmacy, University of London

  • Fellow, Royal Society of Chemistry
  • Fellow, Royal Society of Biology
  • Fellow, Royal Society of Art
  • Member, Drug Information Association Biotechnology Expert Group
  • Member, European Law Association
  • Fellow, Royal Pharmaceutical Society of Great Britain

Languages
  • Chinese
  • French
Overview

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