The period from application for approval of a new drug to its drug price listing (market launch) in Japan is very easy to understand in terms of predictability. Also, apart from the United States, where private insurance accounts for a significant portion of the market, Japan has an environment where anyone can use new drugs at an early stage while keeping their out-of-pocket expenses low under public insurance compared to European countries.
Here, we give an overview of the period from pre-market review application to drug price listing for new drugs in Japan.
Pre-market review (approval) period
For regular new drugs, the target pre-market review period in Japan is set at 12 months. For priority review items such as rare disease drugs, the target period is 9 months.
This setting is mentioned in the PMDA’s business plan, etc. For example, the 2024 business plan can be found here (in Japanese), and it is clearly stated that for regular new drugs and priority review new drugs, 12 months and 9 months will be achieved at the 80th percentile, respectively. Therefore, although there may be exceptions, it is an intention to achieve the target period for 80% of items. (Also, in recent years, this goal has been achieved.)
This pre-market review period is the total review period that is the sum of the time available to the applicant and the review side (PMDA). In the European EMA and the US FDA, the meaning is very different because the review side (regulators) sets the period based on their time available.
In Japan, not only the review side (PMDA) but also the applicant side (Marketing Authorization Holder) are required to make efforts to achieve the targeted pre-market review period. From the perspective of the PMDA, it means that efforts are required to avoid wasting the applicant’s time by asking meaningless questions, etc.
In addition, since it is set based on the total review period, it becomes easier to predict the timing of approval.
Drug price listing period
The period from the submission of a request for drug price listing to the drug price decision is specified in the “Handling of Drug Price Listings for Medical Drugs.” The most recent notification was issued on February 14, 2024 (here in Japanese). The latest notification is issued in accordance with the medical fee revision/drug price revision, but the following rule has been specified and used for a long time.
This operating rule is that “the standard administrative processing period until the listing of a new drug price is implemented is within 60 days, and at the latest 90 days, from the approval of the new drug.”
Therefore, new drug prices are listed in the drug price list within 60 days of approval (commonly known as the 60-day rule).
This 60-day rule is the result of the Japan-US trade negotiations, the MOSS negotiations, and is operated based on the 1986 agreement. The origin of this rule is explained in detail here (in Japanese).
In Japan, new drugs are available to everyone under public insurance within 60 days of approval, making for a fast and predictable schedule.
Summary
In Japan, it takes 9 to 12 months from pre-market review application to approval for new drugs, and 60 days from approval to drug price listing. Therefore, new drugs can be made available under public insurance in less than two years from the pre-market review application.
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