How To Launch A New Drug On The UK Market 

Think you’ve got the next best thing in biopharma? Where do your medical drugs come from? Drugs like ibuprofen and paracetamol are so commonly used that sometimes we forget to think about where they came from and the processes they had to go to to ensure they were safe and effective for home use. 

In this article, we’ll explore how to launch a new drug on the UK market – so you can understand the processes a drug goes through before it’s commercially launched to people across the country. 

#1 Biopharma Research and Pharmacovigilance 

Did you know that launching a new drug used to take decades? It used to take a long time to get research results for your drug and keep up-to-date with biopharma developments, but today, thanks to Artificial Intelligence systems and specialist biopharma research agencies, it’s much easier to get the information you need. 

A big part of this process is biopharma research and pharmacovigilance. Biopharma research is one of the first and biggest steps to launching a new drug – it explores all safety issues raised in biomedical literature about your medicinal products and those like them. It’s a really important part of launching a drug as it helps ensure that your drug is as safe as possible before you begin testing it on people.  

‘Pharmacovigilance’ is a branch of biopharma research; it means remaining vigilant about developments within pharmaceuticals – especially regarding drugs with a similar formula to yours. If you find out that patients are having a bad reaction to a drug with a similar formula currently in testing, pharmacovigilance can help you to amend your formula. 

#2 Human Drug Trials 

There’s no use in launching a drug unless you know it works for people, and this is why human trials need to be conducted as soon as the drug is proven to be as safe as possible. The first set of human subjects will normally be volunteers who have been offered money in exchange for participating in the trials. Usually, there are three stages to the trails:

  1. Healthy human volunteers test the drug and report back on side effects. As the people using it don’t suffer from the health condition, it won’t show you if the drug is effective (for example, you can’t see how useful a migraine medicine is on someone who doesn’t suffer migraines). However, it helps drug developers to identify if any negative side effects come from the drug. If the drug works without negative effects, move on to stage 2. 
  1. Clinical trials come next – meaning you’re finally able to test your drug on those with the condition it aims to treat. You’ll work with much larger groups of people over a much more sustained period for this stage and closely monitor the effects of your drug. You’re trying to figure out the answer to the question: does it fulfil its purpose? If the answer is yes, you can move on to stage 3. 
  1. If stage 2 proves the drug is effective, the drug trials will be opened to a much larger group. Thousands of people across many focus groups will take the drug nationwide. This stage will often last a few years and helps to prove that the drug has mass appeal and use. 

#3 Getting Your Licencing 

Now that your drug has been proven safe and effective, you’ll need the right licensing to sell it on the UK market. The UK licensing board will look at all the data you’ve collected from research and trials to conclude whether the drug is: 

  • Safe to use
  • Effective at treatment 
  • Meets UK manufacturing quality standards 

The regulatory authorities will issue you a licence or marketing authorisation if it meets these standards, allowing you to distribute your drug in areas covered by that licensing board. 

#4 Get Your Drug Prescribed By The NHS 

You’ll need to undergo a second licensing process if you want the NHS to prescribe and distribute your drug. This is because your drug needs to be approved by specific medical boards to prove effective enough to treat more serious medical conditions. Though this does take some extra time, it can be a fantastic benefit, as public bodies like the NHS may fund further development of your drug if it’s reliable. 

#5 Launch Your New Drug 

Once your drug is researched, tested and licensed, you’re ready to start marketing and selling it. We hope this guide to launching a new drug on the UK market has given you some useful insight into how a drug makes it to commercial markets and how much time and effort goes into ensuring that they’re safe and useful for public consumption. 

Shahbaz Ahmed
Author: Shahbaz Ahmed

My name is Shahbaz Ahmed. I am author on Ventsmagazine. For any business query, you can contact me at [email protected]

About Shahbaz Ahmed

My name is Shahbaz Ahmed. I am author on Ventsmagazine. For any business query, you can contact me at [email protected]

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