Named Patient Program (NPP) provide controlled, pre-approval access to drugs in response to requests by physicians on behalf of specific, or “named”, patients before those medicines are licensed in the patient’s home country. Through these programs, patients are able to access drugs in late-stage clinical trials or approved in other countries for a genuine, unmet medical need, before those drugs have been licensed in the patient’s home country.
Named Patient Program (NPP) provide controlled, pre-approval access to drugs in response to requests by physicians on behalf of specific, or “named”, patients before those medicines are licensed in the patient’s home country. Through these programs, patients are able to access drugs in late-stage clinical trials or approved in other countries for a genuine, unmet medical need, before those drugs have been licensed in the patient’s home country.
What is Named Patient Program (NPP)?
It is common in certain cases, that drugs are already discovered, but not marketed in every global region due to ongoing approval processes or products are under the late-stage of clinical research. Named Patient Program breaks the gap between such medication accessibility to physicians and patients. Named Patient Program gives the freedom to the physician to prescribe medication that is available in well-established pharma- markets. Both physicians and patients can order these medications by providing necessary documentation required to prove the actual need of the drug/s.
Named Patient Program has the accessibility to all well-established pharma- markets and sponsors for sourcing the necessary medications. Named Patient Program brings the global marker under one umbrella for physicians, patients as well as for sponsors. Named Patient Program maintains all the regulatory and logistics requirements to provide hassle-free service to all the consumers.
Uses Of Named Patient Program
Named Patient Program is useful for all the pharma sponsors also. Usually, sponsors want to launch their products in the popular markets where they get more patients and well-established pharma markets of the USA, Europe, and Japan or other such vast markets. But Name Patient Program gives them a scope to market their products beyond commercialization.
The patient from any country who is recognized as ‘the Named Patient’ and suffering from the chronic, serious, or life-threatening disease has the right to access, procure, and import medicines which have life-saving potentiality or improve the quality of life of the patient. But rules and regulations for importing innovative medications are different in every country. Every country has to follow its own regulation to import such medications. Different programs are already existed such as Named Patient Import, Early Access Program, and Compassionate Use Program specifically available to import such medications. However, every country follows its own 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 NPP.
These may be drugs that are:
- Approved but not yet commercially available to be prescribed in the patient’s country.
- Approved and available in one country but not approved and available in the patient’s country.
- Discontinued in the patient’s country but not another.
- In shortage in the patient’s country but not another.
