Drug Information Q&A Q39. What is the "drug lag"? What are the government and the pharmaceutical industry doing about it?
Answer
Drug lag refers to the difference in the amount of time it takes for drugs used overseas to be approved and available in Japan. The government and the pharmaceutical industry are working together to make drugs available in Japan as quickly as possible for the benefit of Japanese patients.
Explanation
There are two aspects to the drug lag: one is the "problem of unapproved drugs" (see Q52), which are not available in Japan even though they are available in other countries. The other is the lag (delay), which means that although a drug has been launched in Japan, it took longer to be launched than in other countries.
The unapproved drug problem can be seen by comparing the number of drugs in the top 100 drugs in terms of sales in the global pharmaceutical market that have not yet been launched in Japan with those in other countries: in 2010, there were 11 drugs in Japan that had not yet been launched, compared to 2 drugs in the U.S. and 2 drugs in the UK.
To solve this problem, in April 2010, the NHI drug price system introduced on a trial basis an additional fee to promote the creation of new drugs and the elimination of off-label drug indications, and the MHLW established the "Study Council for Unapproved Drugs and Indications with High Medical Needs". The Ministry of Health, Labour and Welfare has established the "Study Council for Unapproved and Off-label Drugs of High Medical Need.
The problem of the long period of time required for the approval and launch of a drug can be seen by comparing the average time from the first launch of a drug in the world to its launch in each country: in 2010, it was 0.9 years in the United States, 1.2 years in the United Kingdom, and 1.3 years in Germany, while in Japan it was 4.7 years, which is behind even developed countries. This is due to the "start of clinical trials. This is due to the fact that "the start of clinical trials," "the time taken for clinical trials," and "the time required for the review of clinical trial results" differ from country to country.
The Pharmaceuticals and Medical Devices Agency (PMDA), which is entrusted by the national government, pharmaceutical companies, and the government to review drugs, is therefore taking the following steps to eliminate the drug lag.
First, the pharmaceutical industry is working to promote international joint clinical trials that are conducted in multiple countries at the same time. By actively conducting joint international clinical trials in Japan, the development of a drug and its application for approval can be conducted at the same time as in other countries, thereby accelerating the start of clinical trials in Japan.
The second is to promote a clinical trial and clinical research network system as a national initiative. Currently, clinical trials and clinical research in Japan are inefficiently conducted in a decentralized manner due to the small size of hospitals compared to those overseas. Therefore, we aim to shorten the time required for clinical trials by establishing core centers, such as core clinical research hospitals, that consolidate the expertise and functions necessary for more efficient clinical trials, and by promoting the networking of multiple hospitals around the core centers.
Third is to increase the number of PMDA reviewers. By increasing the number of reviewers and increasing their experience, it is expected that the review process will be expedited. We are also enhancing the consultation between pharmaceutical companies and PMDA regarding clinical trial methods from the drug development stage.
In this way, the government and the pharmaceutical industry are continuously working to eliminate the drug lag as early as possible through a variety of activities. Many Japanese patients want to use drugs that are available overseas. The government and the pharmaceutical industry are making efforts to shorten the drug review period and improve the clinical trial environment (see Q34 and Q35) to bring better drugs to patients as quickly as possible.
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