Introduction
Japan has one of the most
efficient drug designation systems in the world. According to their
Pharmaceutical Affair law, drugs and medical services can be categorized as
orphan drugs and distributed to less than 50,000 patients who are in dire need
for medical attention.
Here are some of the
important aspects about Japan orphan designation system that you should know
about.
Number
of patients:
As mentioned earlier, the
drugs and medical services can only be made available to less than 50,000. The
number of patients that need these services is estimated using the latest
Health and Labor science research or any other form of scientific data
published by independent research societies and organizations.
Nature
of the medical needs:
The medical devices and drugs
should be used to treat serious diseases that cannot be treated using any other
treatment method. The medical needs must indicate that they require a high
safety or efficacy that current existing products do not meet.
Development:
For this form drug dissemination
to be approved there has to be a clear theoretical development plan. The plan
should be able to deliver a drug that best suits the target disease. For
example, the development plan should be based on the current clinical and
non-clinical data.
The drugs must also meet the
marketing authorization criteria that they are specifically designed for. The
personnel should also ensure that the supplies get to the target patients as
soon as possible. Also, the re-examination period of the drug may be extended
for a period not exceeding 10 years after approval of the designation.
Reference : Pacific link consulting
