How A New Drug Is Launched

Drugs like paracetamol and ibuprofen are used by millions of people daily. They’ve become a part of most people’s daily lives, but have you ever wondered where they come from?

It’s an incredibly difficult process to launch a drug. Only one or two in every 10,000 tested will make it to the market, so when you think about the hundreds of drugs you might find in a pharmacy, tens of thousands more didn’t make the licensing cut.

It can take decades for a drug to make it from the test tube to your medicine box, as it has to go through a process of development, safety checks, effectiveness testing and quality control. In this article, we’ll break down the stages of drug production and explain how a new drug is launched to the public market.

Stage One: Pharmacovigilance and Drug Safety

So, let’s say you’ve prepared a new drug that you think will help many people and sell well. This process could have taken years, and you believe that the product that you have is going to make a genuine difference.

Before you move on to testing your drug on anyone, you must ensure that it is as safe as possible. This is where pharmacovigilance and drug safety checks come in – they’re the process of checking safety issues raised in biomedical literature about your medicinal products. This process will also come in helpful safety for your proper test trials, as it will help to review issues that people have reported with your drug.

‘Pharmacovigilance’ means to remain vigilant about developments within pharmaceuticals, particularly pertaining to your specific drug and those with similar formulas. It helps you to understand where there may be issues with the drug’s formula and where you may find particular threats to safety.

It’s very important to conduct all of these checks before you take your drugs to market and a mix of A.I and pharmacovigilance experts can help you to do this. Medical literature can be your greatest asset in understanding how to develop the best drug possible.

Stage Two: Drug Testing On Humans

Now that you’ve researched and determined that your drug is as safe for use as possible, it’s time to begin trialling it on human subjects. These subjects are drug testing volunteers who have often been awarded money for participating in the trials. Their job is to report back on any effects of the drug, as well as participate in things such as reviews and blood-pressure checks to help improve your research and understanding of the drug’s efficiency. Drug testing can loosely be broken down into three sub-stages:

• Stage One Volunteer Trials – The first stage is testing healthy participants. This will give you an understanding of how the drug works and possible side effects. Using a healthy subject often won’t show you how efficient the drug is at solving the issue it’s developed for (for example, if it’s for chronic migraine relief, testing it on a subject who doesn’t suffer from migraines won’t show you if it can stop them) but it will show you if the drug causes any adverse reactions. As the subject is healthy, they’ll be much more able to cope with any side effects.
• Stage Two Clinical Trials – If the first stage is successful, you can move on to testing your drug on people with the condition it treats. This stage will often last much longer, often several years, and usually involves a couple of hundred subjects. It’ll follow them over a sustained period of time to monitor how the drug works and how it combats the issue at hand. This type of testing uses a couple of investigative methods:
• Controlled – some people will be given a placebo (fake drug) to test the efficiency of the real drug. This will help researchers to see if the drug works or if people think it’s working (the placebo effect).
• Double-Blind – neither the investigators nor participants know who is getting a real drug and who is getting a placebo.
• Randomised – study participants are randomly allocated to receive active treatment or placebo.
• Stage Three Universal Trials – If stage two proves the drug is effective, the drug trials will be opened to a much larger group. Thousands of people will take the drug in numerous clinics worldwide. This part of testing will also last for quite a few years until there is sustained proof of the drug’s efficiency and safety.

Stage Three: Licensing And Launching

Now that your drug has been tested and confirmed to be safe and efficient; you can apply for your licensing.

The licensing board for your country will review all of the data from the clinical trials and research to ensure that the drug is:

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

The regulatory authorities will issue you a licence or marketing authorisation if it meets these standards. This allows the product to be sold by you in the areas covered by the licensing board.

You may still need to go through a second process if you want your drug to be used by a medical board such as the NHS, as it must be approved by specific boards such as NICE and SMC. However, this can be a great benefit, as the NHS will fund your drug if it’s reliable.

What Happens When Your New Drug Is Launched?

Now that we’ve been through how a new drug is launched, we can look at what happens next. Once your drug has its licensing, it’s ready to market.

The business side of marketing comes here, as branding and advertising help you sell your drug and get its name out to the public. A drug may still enter phases of development after its launch, as you may discover ways to make it better and improve its formulas as medical technology advances.

Even though you may have an incredibly successful drug on the market, the development process never stops. You want to keep your drug at the top of its game, so you don’t stop developing it just because it’s doing well!