Preapproval vs unapproved or elsewhere approved medicines

What’s the difference between a ‘pre-approval’ medicine and an ‘unapproved’ or ‘elsewhere approved’ medicine’?

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‘Unapproved medicines’, ‘compassionate use’, ‘early access drugs’...

With so many different terms floating around, it can be confusing if you’re a patient looking to access new treatment options. Our Patient Support Team are regularly asked about the types of medicines we’re able to source and deliver. Watch the video below or read the text below to learn more about the difference between ‘pre-approval’ and ‘elsewhere approved’ or ‘unapproved’  medicines:

Whilst these terms can mean different things in different contexts, ‘pre-approval medicines’ commonly describes medicines that have not been approved anywhere in the world. These medicines are still being studied and tested to see how safe and effective they are in humans.

Sometimes patients are able to access these pre-approval medicines by participating in a research study. This is called a clinical trial, which is free of charge. In clinical trials there is no guarantee that patients will actually be treated with the new medicine, since most trials require a ‘control group’ of patients that are given either a placebo or the current standard treatment so that results can be compared.

Another option is applying for an ‘early access’ or ‘compassionate use’ program. These special programs are allowed through a special provision in the law. They enable patients with a life-threatening or debilitating disease who have exhausted existing treatments options access a medicine that is still being tested.

‘Unapproved’ or ‘elsewhere approved medicines’ are terms that are often used to describe medicines that have not been approved in the patient’s home country, but have already been approved by a regulatory agency somewhere else in the world, for example by the FDA in the US, or the EMA in the European Union. Most countries allow their residents to import medicines that have already been approved in another country, provided that the medicine is being imported for personal use. This means that the patient may have to import the medicine at its full price, because it isn’t subsidised by the country’s health system. However, there are exceptions. Take for example edaravone, a treatment for amyotrophic lateral sclerosis (ALS) which was approved in the US in May 2017. The cost of the medicine is being reimbursed to patients in Italy, even though it is not approved there.

It can also be possible to access ‘elsewhere approved medicines’ via local clinical trials that are being run for the medicine’s local approval. However as with pre-approved medicines, patients often need to meet strict suitability criteria.  

We only source and deliver ‘elsewhere approved’ medicines that have been approved by a reputable medical agency somewhere in the world. If you’re looking to purchase a medicine that is still being developed and tested (in clinical trials), please do still get in touch and with us and our qualified pharmacists will do our best to point you in the right direction.



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