What Is Involved In Drug Licensing?

When you are researching and developing a new drug there are a number of rules and

regulations that you will need to follow if you want your drug to be approved. Drug development is a lengthy process and is not for the faint hearted, but if you firmly believe that your drug will be able to aid in the treatment or curing of a disease it is definitely worth it.

One of the many steps in drug development is licensing, which is required by law. In the UK the process is carried out by the Medicines and Healthcare Products Regulatory Agency (MHRA) and includes the verification of your drug. There are a number of key points that will be looked at during the licensing process, including how safe your drug will be for general consumption. If your drug produces damaging side effects, the chances of your drugs success will greatly diminish.

It is normal for drugs to have certain side effects and essentially all drugs currently on the market are guaranteed to produce side effects in certain people. These are usually limited to headaches, blurred vision or nausea though and patients are always advised to stop taking the medication if they experience them.

If it is revealed during the licensing process that your drug causes more serious side effects, such as seizures or heart defects, it will fail. This is to protect potential patients and is an essential part of the licensing process. To uncover these side effects the MHRA will test your drug first on animals and then humans, so they will be able to ascertain the exact side effects to expect.

When putting your drug forward for drug licensing you should inform the MHRA of the side effects you are already aware of. Sometimes, drugs that have an acceptable risk to benefit ratio will be accepted. For instance, some steroids are known to have a potential risk of causing tumours, but because they are so effective in treating other illnesses they are allowed.

The key to getting your drug approved for licensing is to correctly do your research beforehand. If you have done this to a high standard you can be almost certain that your drug will pass through licencing, after which you can submit it for drug pricing and distribution.

If you would like to learn more about the drug licensing process you can search online now.

by: Alan Trotter

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