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Due to the corona crisis, a special approval system that has made it possible to launch vaccines and therapeutic drugs for new coronavirus infections several years earlier than before has attracted attention. In the past, it was said that the review of new drugs took a long time in Japan, and that the introduction of new drugs was several years later than in Europe and the United States. Therefore, we would like to introduce the mechanism of pharmaceutical approval for pharmaceuticals based on recent trends.

Prescription drugs are reviewed and approved based on the Pharmaceutical and Medical Device Law (Law Concerning Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices), etc., but there are several processes before they are approved. First, we examine the efficacy and toxicity of drug candidate substances using animals and cells. Next, we will administer the drug to a small number of healthy adults and study its absorption, metabolism, excretion, etc. (Phase I study). Furthermore, administering to a small number of patients with the target disease to investigate efficacy and safety (Phase II study), and then administering to a large number of patients to examine efficacy and safety (Phase III study) . Phase II and III trials will be double-blind and randomized controlled trials. Phase III trials involve more than 200 people and take several years.

A pharmaceutical company that summarizes clinical trial results, etc., submits an application to the Ministry of Health, Labor and Welfare in order to obtain marketing approval for a new drug. The organization that issues approval is the Ministry of Health, Labor and Welfare, but the organization that reviews the approval is the Pharmaceuticals and Medical Devices Agency (PMDA). PMDA conducts reviews based on new drug data and clinical trial results, after which the Pharmaceutical Affairs and Food Sanitation Council, an advisory body to the Minister of Health, Labor and Welfare, deliberates based on the review report prepared by PMDA. . If it is concluded that the drug is suitable as a drug, the Minister of Health, Labor and Welfare will grant marketing permission. It takes about 1 to 2 years from application for approval to approval.

The number of new drugs approved in Japan in 2021 was 135 items, an increase of 10 items from 2020, and more than the average number of approved items of 118 items from 2010 to 2020. The median review period for all products approved in 2021 is 9.9 months, 0.8 months shorter than in 2020, and has been around 10 months since 2011, when the review period was significantly shortened.

Drug reviews may be subject to conditional exceptions to speed time to market for new drugs. In May of this year, the Pharmaceuticals and Medical Devices Law was revised, and an "emergency approval system" was established. If safety is ensured in clinical trials equivalent to phase II trials and efficacy is estimated, it can be urgently approved. However, it is necessary to show clinical trial data proving its efficacy within two years after approval. The first product under the emergency approval system is Zokova, the first domestically produced corona treatment drug. In addition, the "Special Approval System" was established for the emergency import of vaccines from Europe during the outbreak of the new strain of influenza in 2010. In order to prevent the spread of health hazards such as infectious diseases, we will promptly confirm both the efficacy and safety of drugs used in Europe and the United States, where medical technology is similar to that in Japan, and promptly approve them. is. In addition, there are the following priority examination systems. (1) The “Pioneering Drug Designation System (Sakigake Designation System)” was established to commercialize innovative drugs and medical devices for the first time in the world. Orphan drug designation system, which targets diseases for which there is a particularly high need・"Conditional Early Approval System", which is approved on the condition that safety is evaluated. Approval system with conditions and time limit”. Such a system will make it easier for companies to prioritize the development of new drugs in Japan, and it is believed that this will lead to an increase in the number of patients who benefit from it.