Drug lag/drug loss
Drug-lag and drug-loss refers to a situation where drugs approved overseas are approved late or not approved in Japan. This can result in missed opportunities for patients to receive treatment.
There are two aspects of drug lag.
The first is development lag, which occurs when a new drug is developed overseas and then delayed in Japan; the second is review lag, which occurs when it takes longer for the Japanese review agency (PMDA) to review a drug for approval than it does overseas. In recent years, the review lag has been significantly shortened and is expected to be almost zero by FY2024.
Drug loss refers to drugs that have been approved overseas but have not even been developed in Japan. This is particularly common in areas where the number of patients is small but the medical need is high, such as cancer, rare diseases, and pediatric diseases.
The background of this problem is that Japan, clinical trials in particular in the Phase III Phase III clinical trials in Japan. Currently, many clinical trials are now being conducted in a multinational manner, with patients from multiple countries participating. In Japan, before participating in a multinational clinical trial, a Phase I trial is conducted to confirm safety in Japanese subjects, even if the trial is conducted on non-Japanese subjects. Phase I trials is required to confirm the safety of a drug in Japanese subjects before participating in a global clinical trial. This has become a major burden for companies developing drugs, and Japan is now in the process of developing a Clinical Trials However, there have been cases in which Japan has been excluded from clinical trials, and now there is no need to conduct Phase I trials on Japanese subjects. Phase I trials However, there is no longer a need to conduct Phase I trials on Japanese subjects. Another factor is the difficulty and uncertainty in predicting the profitability of the Japanese market. Japan has a system of periodic drug price reductions, and the Japanese population is also declining. As a result, foreign venture companies and others without a base in Japan may put off or not develop their products in Japan.
In response to these issues, the MHLW is organizing information on drugs that have not been developed in Japan and requesting companies to develop them. In addition, the PMDA supports the entry of overseas companies by promoting international joint clinical trials, handling applications in English, and strengthening the consultation system.
In addition, the "SCRUM-Japan" and "MASTER KEY Project" led by the National Cancer Center are promoting the use of genome information to provide patients with cancer and rare diseases with personalized medicine These efforts are aimed at promoting personalized medicine and the early introduction of new drugs for patients with cancer and rare diseases using genome information.
These efforts are expected to eliminate drug lag and drug loss, but more continuous improvement is required so that patients can receive the treatment they need.