[医药卫生]Drug Development1.pptVIP

Medicines and Healthcare products Regulatory Agency (MHRA) An executive agency of the Department of Health Our role is to enhance and safeguard the health of the public by ensuring that medicines and medical devices work, and are acceptably safe. Any opinions expressed in this presentation are: my own and can not be considered to be MHRA policy Where are we MHRA 2011- EMA LMU Drug Development From laboratory to the market – role of regulatory agencies Intended learning outcomes After this lecture students should be able to: Understand and describe the different stages of drug development Appreciate the role of regulatory agencies in the drug development process Overview The development of new and better medicines is central to public health and quality of life Average 10-15 years for a drug to become a medicine Drugs coming on to the market today were in early research in 1990’s Requires a great deal of expertise and costs millions 1000’s of chemicals tested never make it out of the laboratory ~ 1 in 10,000 will end up as a prescription medicine The Tufts Centre for the Study of Drug Development estimated that it was costing $1.3 billion in 2006 to bring each new drug to market.  Adams CP, Brantner VV. Spending on new drug development Health Econ. 2010 Feb;19(2):130-41. New Molecular Entities approved by FDA CDER New Drug Review:2011 update /drugs/Drugs/DevelopmentApprovalProcess/DrugInnovation/default.htm Who regulates medicines Whether it’s cough mixtures or cancer drugs, all medicinal products have to be licensed before being put on the market A market authorisation Quality – is the medicine well made? Safety - is the medicine safe for intended use? Efficacy - does the medicine work for intended use? Benefit vs Risk Medicines Regulatory Agencies Medicines quiz Questions: Which of these are medicinal products? Which of these are regulated by the MHRA? What is a Medicinal Product? ‘Medicinal product: Any substance or combination of substances presented as h