Information & signposting

Understand the question.
Find the right next step.

For patients, families, carers, patient organisations and professionals who want clearer information about access processes and responsibilities.

Begin with what you need to know.

A term in a letter, a general policy or a programme described in another country can raise more questions than it answers. Start by separating the process from the individual clinical decision.

This page offers general explanations and official sources. You can use them without contacting IAE. We do not assess eligibility, obtain medicines or manage individual treatment-access cases.

Who can answer?

A treatment decision

Your treating healthcare team considers clinical options, suitability and the questions specific to your care.

Prepare questions for your team

A programme or access request

Use the responsible company’s or programme’s advertised channel, through a healthcare professional wherever required. A general policy is not confirmation that a particular request can proceed.

Check the official process

A term or general process

Read the explanations below. If the terminology or responsibility remains unclear, IAE can consider a non-identifying general question.

Ask a general process question

Some useful distinctions.

The relevant country and official programme determine the applicable process.

Does an access programme mean a clinical trial?

The purpose and rules may differ. In the US, the FDA describes expanded access as treatment with an investigational product outside a clinical trial under specified conditions. Ask which arrangement is being discussed and who is responsible for it. Read the FDA patient explanation

Does a published access policy confirm availability?

It sets out a company’s approach. It does not, by itself, confirm a programme for a particular medicine, country or person. Availability and individual decisions must be clarified through the advertised programme or company route and the treating team.

What should I ask when a trial is ending?

Ask the study team what the study documents and sponsor arrangements say about treatment after participation ends, who can explain the position and when that discussion should happen. An access route elsewhere does not establish an individual entitlement.

Can a patient import a medicine personally?

Some jurisdictions permit certain personal imports under specific conditions. Australia’s TGA describes a personal-importation scheme with prescription, quantity, product and other restrictions. That example is not permission to import a particular medicine or a rule for another country. Read the TGA requirements

Can IAE clarify a general regulatory hurdle?

We can consider questions about a published process, unfamiliar term or responsible organisation and signpost to official information or patient organisations. Describe the process and relevant country, without patient names, records or prescriptions. This is not an urgent-response channel or individual case management.

Take a clearer question into the conversation.

Which arrangement are we discussing, and does it apply in this country?
Who is responsible for confirming the position or making a request?
What information does that person or organisation need?
When should we expect an update, and what is the next step if the route is unavailable?

These questions help organise a discussion. The treating team and responsible company or programme provide the answers for an individual situation.

Go to the responsible source.

Selected examples, checked 26 September 2026. Requirements can change; always read the current official guidance.

United Kingdom · MHRA

Guidance on the regulated supply and import of unlicensed medicines. The responsible prescriber determines special clinical need.

Read MHRA guidance

United States · FDA

Patient information explaining expanded access and the roles of the physician, company, ethics review and regulator.

Read FDA patient information

Australia · TGA

Conditions and restrictions for the personal importation of therapeutic goods.

Read TGA guidance

These examples are not a global route directory or confirmation of medicine availability. For another country, use the national regulator and advertised company or programme channels.

Independent information. No alternative access route.

IAE’s advice is independent of a medicine supply or logistics sale. We cannot receive, submit, broker or progress treatment-access requests, arrange supply, act as importer or provide medical advice.

Where a healthcare professional must make the request, use that route. Where a patient may have a personal-importation role, IAE’s contribution remains general explanation and signposting; we do not establish personal entitlement.

A clearer view of the next decision.

Expanded access, early access, NPP and MAP explained Patient and public involvement explained

A process still unclear?

Send the term or general process you want to understand and the relevant country, if known. Please leave out patient-identifiable information.