What is meant by named patient program?

A Named Patient Program (NPP) provides patients and physicians access to commercially approved medicines that are not available to them in their own country. These drugs must be approved in at least one country, from which it can be imported into the patient’s country under a NPP.

What is a named patient basis?

“Named-patient basis” is another way of obtaining medicine before authorization where a doctor requests supply of an unauthorized medicine directly from the manufacturer to treat an individual patient under the doctor’s direct responsibility.

What is the difference between compassionate use and named patient use?

Compassionate use should not be confused with ‘named-patient basis’ treatments, which see doctors obtain medicines directly from manufacturers before authorisation. This is done on an individual basis under the direct responsibility of the doctor, and the Agency does not need to be informed.

What are named patient sales?

Named Patient Supply means that a Licensed Product is sold for use by an individual patient, based on the decision of a physicians’ commission and imported pursuant to a special import license before any Regulatory Approval is obtained to cover such patient, if allowed under Applicable Laws and the Parties’ policies.

Does compassionate use require IRB approval?

Compassionate use means that the use does not meet the criteria for emergency use, and therefore prior FDA approval (IDE) is required before the device can be used. Standard IRB review and approval (like a research study) is required for neither emergency nor compassionate use.

What does MAP mean in pharma?

Medication Administration Program (MAP)

What is the early access to medicines scheme?

The Early Access to Medicines Scheme (EAMS) helps to give people with life threatening or seriously debilitating conditions early access to new medicines that do not yet have a marketing authorisation but where there is a clear unmet medical need.

What is an expanded access program?

Sometimes called “compassionate use”, expanded access is a potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable …

Who pays for experimental drugs?

You may pay out of pocket for experimental treatment. The drug company may charge you for the experimental drug. Also, your insurance company is unlikely to pay associated costs of your treatment, such as fees for your doctor to administer the experimental drug and monitor side effects.

What is a compassionate use program?

What is a specials Licence?

Guidance on manufacturing, importing, distributing and supplying specially manufactured or ordered products, including cannabis-based products for medicinal use in humans (CBPMs), known as ‘specials’