November 28, 2021
A drug (Iyakuhin, English: medication) is a drug given to diagnose, treat, or prevent diseases in humans and animals. The forms of use include those to be taken (internal medicine), those to be applied (external medicine), and those to be injected (injection) (see dosage form). There are prescription drugs prescribed by a doctor and over-the-counter drugs that can be purchased at pharmacies. A drug is approved as a generic drug (new drug) if it is shown to be effective in a clinical trial. After 20 years have passed since the launch of the new drug, generic drugs will also be sold.
Definition and classification of medicines
Definition by the Pharmaceuticals and Medical Devices Act
It is defined as follows in Article 2 of the Pharmaceuticals and Medical Devices Act of Japan.
Items contained in the Japanese Pharmacopoeia
Items intended to be used for the diagnosis, treatment or prevention of human or animal diseases, not mechanical instruments, dental materials, medical supplies and hygiene products (excluding quasi-drugs)
Items that are intended to affect the structure or function of the human or animal body and are not mechanical instruments, dental materials, medical supplies and hygiene products (excluding quasi-drugs and cosmetics) 1. Drugs listed in the Japanese Pharmacy are called Japanese Pharmacy drugs. It is roughly divided into Part 1 drugs and Part 2 drugs. The Pharmacopoeia is revised about once every five years, but during that time, a supplementary edition is issued about once every two years, and the listed drugs are reviewed. The latest version was published by the 16th revised Japanese Pharmacy on March 24, 2011. The Japanese Pharmacopoeia has listed only those that have a clear usage, effect, mechanism of action, etc., but compared to the United States Pharmacopeia (USP), etc., the number of listed drugs and their contents are the current drugs. Since it was pointed out that this is not the case, new drugs are being actively listed. However, some problems remain due to drug prices and their handling. Some of the ginger and honey listed in Part 2 are used as food.
In order to distribute the drug as a drug in Japan, including transfer, approval for manufacturing and marketing by the Minister of Health, Labor and Welfare is required. Drugs, quasi-drugs, cosmetics, or medical devices that are not approved cannot be claimed as "indication" or "effect". Products claiming to be effective as pharmaceuticals are subject to punishment as "unapproved pharmaceuticals", except when they are claimed to be within the permitted range of health foods.
Classification of medicines
Japanese medicines are classified as follows (excluding veterinary medicines).
Prescription drugs-Pharmaceuticals that are used by doctors or for the purpose of being used by their prescriptions or instructions. Face-to-face sales are required. In September 2000, the naming method for sales names was unified, and the sales names of existing products were changed as alternative new applications. Prescription drugs, which accounted for about 88% of Japan's domestic drug production in 2015
A drug that cannot be purchased by the general public without a prescription from a doctor. To obtain it, you need to see a medical institution such as a clinic and get a prescription from a doctor or dentist.
Medical drugs other than prescription drugs
As with prescription drugs, the principle is to deliver drugs based on prescriptions, but if the conditions are met in the 2005 notification, it has become possible to purchase medical drugs other than prescription drugs without a prescription. However, since general pharmacies refrain from selling to the general public, it is not possible to sell without a prescription.