This article is for people who are curious about what amount and level of evidence is needed for a veterinary drug to get a marketing licence in the UK.
The article defines what a medicine is, what type of products need a marketing authorisation, and which don't. It outlines the different routes that companies can use to get their products licensed and explains in broad terms what sort of evidence they need to present (whether for a branded or a generic product). It also gives examples of the more specific requirements for certain types of products. At the time of licensing more is known about efficacy of a product than its safety, and so the article explains why and how continued monitoring of safety is necessary while a product is on the market.
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Key contributors to this article were Helen Barnett (medical and pharmaceutical writer and editor), Paul Cooper (specialist in veterinary regulation) and representatives of the Veterinary Medicines Directorate and the pharmaceutical industry (including the National Office for Animal Health). Practising vets also contributed to the article to help ensure the article's relevance to readers. Veterinary Prescriber articles are written in a succinct simple style, avoiding jargon and unnecessary acronyms and are unsigned, reflecting the collaborative approach.
This article serves as an introduction to medicines regulation. We will get to learn more about the evidence base that supports specific products in future reviews of new drugs (look out for our review of oclacitinib in the next few months).