This time, we will talk about “in vitro diagnostic drugs,” which have been attracting attention recently.
We will introduce the background and overview!
Definition of in vitro diagnostic drugs
Due to the spread of infectious diseases, in vitro diagnostic drugs such as PCR tests are attracting increasing attention. So, what kind of products can be "in vitro diagnostic drugs"?
According to Article 2, Paragraph 13 of the old Pharmaceutical Affairs Law, ``Among the drugs intended exclusively for the diagnosis of diseases, It refers to products that are not used directly on the human or animal body."
In other words, although it is only a "medicine", Requirements for in-vitro diagnostic drugs to “not be used directly on the human or animal body”.
(Incidentally, there are in vitro diagnostic reagents for animals, but the regulatory authority is the Ministry of Agriculture, Forestry and Fisheries.The approval process is very similar to that for humans, but the approval process for in vitro diagnostic reagents for animals is better. It tends to be a little more difficult.)
Furthermore, by using human-derived samples as specimens and detecting or measuring substances in the specimens, There is a scope stipulation that the object is intended for use in diagnosing a disease.
Range of in vitro diagnostic drugs
The range of products that can be treated as in vitro diagnostic drugs is: It is stipulated that it conforms to three elements: (1) purpose, (2) target, and (3) form.
①Purpose
It must be for one of the following purposes:
・Diagnosis of the degree of various biological functions (functions of various organs, immune ability, blood coagulation ability, etc.)
・Diagnosis of presence or absence of disease, location of disease, and degree of disease progression
・Diagnosis of treatment method or degree of effectiveness of treatment
・Diagnosis of pregnancy status
・Diagnosis of blood type or cell type
②Target
Devices that detect or measure the following substances or items:
-Amino acids, peptides, proteins, sugars, lipids, and nucleic acids. Electrolytes, inorganics, water, etc.
・Hormones, enzymes, vitamins, coenzymes, etc.
・Drugs or their metabolites
・Antigens, antibodies, etc.
・Viruses, microorganisms, protozoa or their eggs, etc.
・pH, acidity, etc.
・Cells, tissues or their components
③Form
・Form in which target substances or items are detected or measured using multiple reagents (including paper, cloth, etc. containing reagents) ⇒ So-called kit
・Form that detects or measures the target substance or item using a single reagent
Background of in vitro diagnostic drugs
In vitro diagnostic drugs were originally classified as pharmaceuticals, as indicated by the word "medicine" at the end.
The hurdles to obtaining permission were high, and there was a stagnation in the spread of in vitro diagnostic drugs in Japan. Under the old Pharmaceutical Affairs Law, in the former Ministry of Health and Welfare's Pharmaceutical Affairs Bureau notification (dated June 60, 6, Pharmaceutical Notice No. 29), The definition was established for the first time as an "in vitro diagnostic drug."
In other words, with the definition of a new framework of "in vitro diagnostic drugs" within "medicines," Permits can be obtained through simpler procedures than for “medicinal products”It came to be.
The Next Development
Examples of in vitro diagnostic drugs often used include: Tests that can be used at home such as blood tests and pregnancy tests You can see tests such as imaging tests and blood tests performed in the hospital.
In the future, tests that are "easy" and "accurate" will become more widespread. Demand for in vitro diagnostic drugs is expected to increase.
