Policy Research Institute page Comparison of New Drug Approval Status and Review Periods in Japan, the U.S. and Europe (2022)

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The number of new drug approvals and review periods for new drugs approved in Japan, the U.S., and Europe in 2022, taking into account the impact of special measures on pharmaceutical affairs in each region. 174 new drugs were approved in Japan in 2022, and 52 new molecular entities (NMEs) were approved, the largest number. The median review period was 9.4 months for all approved products and 10.8 months for NMEs, which was similar to the previous year, but the median review period was the smallest in Japan compared to Europe and the United States. In addition, the number of approved regenerative medicine products has been increasing in Japan, the U.S., and Europe in recent years, and the number of global products has also increased.

1. Introduction

The NIHS has access to information on drug approvals and review periods in Japan, the U.S., and Europe from the Pharmaceuticals and Medical Devices Agency (PMDA), the U.S. Food and Drug Administration (FDA), and the European Medicines Agency (EMA). Policy Research Institute News No. 67*2 compares the status of new drug approvals and review periods in Japan, the U.S., and Europe, focusing on approvals in 2021, while Policy Research Institute News No. 68*3 provides an analysis of information on drugs approved in Japan in 2022. In Policy Research Institute News No. 68*3, we reported the results of our analysis of information on drugs approved in Japan in 2022. In this issue, we report on the number of new drugs approved in Japan, the U.S., and Europe in 2022, as well as their review periods.

Survey Methodology

The information published on the PMDA, FDA, and EMA websites was used in standard statistical analysis software Stata/IC 14.2 for Windows (Stata Corp LP, College Station, TX, USA), and the review period was calculated as the period from the date of application for approval to the date of approval. The review period was calculated as the period from the date of application for approval to the date of approval.

The number of NMEs was calculated based on the number of review reports. When multiple companies simultaneously submitted applications for an item with the same ingredient or multiple ingredients were approved for concomitant drug therapy, the number of NMEs was counted as one item. NMEs were counted if the application was classified as a new active ingredient.

In the U.S., New Drug Application (NDA) and Biologic License Application (BLA) approved by the FDA Center for Drug Evaluation and Research (CDER) are listed in "CDER Drug and Biologic Approvals for the Calendar Year " *5. NMEs were included in the "CDER New Molecular Entity (NME) and Original Biologic Approvals Calendar Year". The NMEs were those listed in the "CDER New Molecular Entity (NME) and Original Biologic Approvals Calendar Year.

The NMEs included drugs classified as "New active substance".

Special regulatory measures include Priority Review, Accelerated Approval, Orphan, Fast Track, and Breakthrough Therapy in the U.S., Priority Review, Accelerated Approval, Orphan, Fast Track, and Breakthrough Therapy in Europe, and Priority Review, Expedited Review, Orphan, and Pioneer Review Designation System*7 and Conditional Early Approval System in Japan. Therapy in the U.S. and Accelerated Assessment, Orphan, Conditional Approval, Exceptional Circumstances, and Priority Medicine (PRIME) in Europe.

Results

(1) Comparison of the number of new drugs approved in Japan, the U.S., and Europe

The number of new drugs approved in Japan, the U.S., and Europe over the past eight years (2015-2022) is shown in Figure 1. In Japan, 174 products were approved in 2022, of which 52 were NMEs. This was the highest number in the past eight years. In the U.S., 112 NMEs were approved in 2022, of which 37 were NMEs. In Europe, 164 products were approved in 2022, of which 56 were NMEs. Since the beginning of the NIH data collection, the number of NMEs approved in Europe was the second highest after 2021, and the highest number of NMEs ever.

Fig. 1 Number of approved products in Japan, the U.S. and Europe over the past 8 years
Note: Figures in the past published data may have been revised due to updating and recalculation of data in the cited materials.
Source: Prepared by the Pharmaceuticals and Industrial Policy Institute based on publicly available information from PMDA, FDA, and EMA.

(2) Number of items approved under special regulatory measures (NME)

The number of NMEs approved in Japan, the U.S., and Europe over the past five years (2018-2022) that received special regulatory treatment was investigated ( Figure 2 ).

Fig. 2 Percentage of NMEs receiving special regulatory measures to the total number of NMEs
Source: Prepared by the Pharmaceuticals and Industrial Policy Research Institute based on publicly available information from PMDA, FDA, and EMA.

Of the 52 NMEs approved in Japan in 2022, 21 (40.4%) received priority review (including orphan drugs and the pioneer review designation system), 0 received expedited review (excluding priority review), 18 (34.6%) received orphan drugs (including the pioneer review designation system), and The number of items designated under the Pioneer Review System was 1 (1.9%), and the number of items subject to the Conditional Accelerated Approval System was 0. The percentage of NMEs for priority review and orphan drugs was at a record high level as in 2021. In addition, seven items (including two NMEs) were subject to special exception approval as a response to the novel coronavirus (COVID-19), and one item was subject to emergency approval.

Of the 37 NMEs approved in the U.S. in 2022, 6 (16.2%) received Accelerated Approval, down from 14 in 2021, the highest number since 2011. 24 (64.9%) received Priority Review, Priority Review was 24 (64.9%), Orphan 20 (54.1%), Fast Track 12 (32.4%), and Breakthrough Therapy 13 (35.1%), the same levels as in 2021.

In Europe, of the 56 NMEs approved in 2022, 5 (8.9%) received Accelerated Assessment, 21 (37.5%) received Orphan designation, 8 (14.3%) received Conditional Approval, 7 (14.3%) received Exceptional In 2022, Conditional approval decreased, while the number of Exceptional Circumstances was the highest since 2014, and the number of PRIME-designated items was the second highest after the nine items in 2020. The number of PRIME-designated products approved in 2022 was the second highest after the nine products approved in 2020.

(3) Comparison of review periods for new drugs between Japan, the U.S. and Europe

The median review period for new drugs approved in Japan, the U.S., and Europe in 2022 was 9.4 months in Japan, 11.0 months in the U.S., and 12.4 months in Europe, with Japan having the smallest median review period. The median review times for NMEs approved in 2022 were 10.8 months in Japan, 11.0 months in the U.S., and 14.0 months in Europe, with similar median review times in the U.S. and Japan.

Table 1: New drug review periods in Japan, the U.S., and Europe
Note 1: Figures in previous published data may have been revised due to updating and recalculation of data in the cited materials.
Note 2: Nine special approvals in 2021 and seven special approvals and one emergency approval in 2022 in Japan are included in the number of approved items only because they differ from the normal review process.
Source: Prepared by the Pharmaceutical and Industrial Policy Research Institute based on publicly available information from PMDA, FDA, and EMA.

(4) Review period for items that received special measures by the pharmaceutical affairs bodies

Table 2 shows the median review times for the items approved in 2022 that received special measures (Japan: Priority Review, Pioneer Review Designation System; the U.S.: Priority Review, Breakthrough Therapy; Europe: Accelerated Assessment, PRIME) to shorten the review period. Table 2 shows the items that received priority review in 2022 in Japan.

Table 2 Review Periods for Items Receiving Special Regulatory Action
* Includes Pioneer Review Designation System and Orphan Drugs in Japan Priority Review
Note: Figures in previous published data may have been revised due to updating and recalculation of data in the cited materials.
Source: Created by the Pharmaceuticals and Industrial Policy Institute based on publicly available information from the PMDA, FDA, and EMA.

In 2022, the number of approved Priority Review items in Japan was all approved (37 items) and NME (21 items), with a median review period of 8.4 months and 9.1 months, respectively. 31 out of 37 items were approved within 9 months, as per the target set by PMDA*8. In 2022, the number of approvals of items under routine review increased from 2021 due to the approval of many items under public knowledge, but the median review period for routine review was about the same as in 2021. The median review time in 2022 was the same as that in 2021.

The number of Priority Review applications approved in the U.S. in 2022 was lower than in 2021 for all applications (40), as well as for NMEs (24). The median and median review times were 8.0 and 8.0 months, respectively, the same as in 2021. The mean and standard deviation of review times increased to 14.5 and 16.9 months, respectively, from 2021, and the variability of review times (standard deviation) also increased, In this report, the review period is defined as the period from the date of initial application to the date of approval, and the total period includes the FDA's review period as well as the time required for the applicant to resubmit data, etc. The review period is defined as the period from the date of initial application to the date of approval. As for Therapy-designated products, 16 products (including 13 NMEs) were approved, with median review times of 11.5 months and 11.0 months, respectively, which is more than the number of products designated for pioneering review in Japan as in 2021.

In Europe, there were five Accelerated Assessment-designated products (all NMEs) among all approved products, and only a few products received priority review compared to Japan and the U.S. However, the median review period for Accelerated Assessment-designated products in 2022 was 8.3 months, more than four months longer than that for non-designated products. However, the median review time for Accelerated Assessment-designated products in 2022 was 8.3 months, more than four months shorter than that for non-designated products.

(5) Annual median review period (Japan, the U.S., and Europe)

Table 3 shows the review period (in months) by year of approval (2000-2022) for drugs approved in Japan, the U.S., and Europe, and Figure 3 shows the annual trend of the median review period. Table 4 shows the review period (in months) for each approval year, and Figure 4 shows the annual changes in the median review period.

The median review period for the entire period covered by the survey was 10.9 months in Japan, 10.1 months in the U.S., and 13.2 months in Europe ( Table 3 ). 2022 maintains the same review period as 2021, with 9.4 months in Japan, 11.0 months in the U.S., and 12.4 months in Europe, with Japan having the lowest median. Looking at annual trends, since the significant reduction of the examination period in Japan in 2011, the median examination period has been approximately 10 months, which is comparable to that of the U.S. The examination period in Europe has also been shortened since 2015 (approximately 12 months).

The median review period for NMEs for all periods surveyed was 10.3 months in Japan, 9.7 months in the U.S., and 14.1 months in Europe ( Table 4 ). Although the median review time in the U.S. increased by 3 months compared to 2021, the median review time in Japan and Europe remained the same as in 2021 ( Figure 4 ).

Fig. 3 Annual changes in median review period (all approved items)
Source: Prepared by the Pharmaceuticals and Industrial Policy Research Institute based on publicly available information from PMDA, FDA, and EMA.

Fig. 4 Annual changes in median review period (NME)
Source: Prepared by the Pharmaceuticals and Industrial Policy Research Institute based on publicly available information from PMDA, FDA, and EMA.

Table 3 Changes in review period (months) (all approved items; 2000 - 2022)
Note 1: Figures in previous published data may have been revised due to updating and recalculation of data in the cited materials.
Note 2: The number of approved items includes only 2 items for special approval in 2010, 1 item for special approval in 2020, 9 items for special approval in 2021, 7 items for special approval in 2022, and 1 item for emergency approval in Japan because the review process for these items is different from the normal process.
Source: Prepared by the Pharmaceutical and Industrial Policy Research Institute based on publicly available information from PMDA, FDA, and EMA.

Table 4 Trends in review period (months) (NME; 2013-2022)
Note 1: Figures in the previous published data may have been revised due to updating and recalculation of data in the cited materials.
Note 2: One special approval in 2020, six special approvals in 2021, two special approvals and one emergency approval in 2022 are included in the number of approved items only because they differ from the normal review process.
Source: Prepared by the Pharmaceuticals and Industrial Policy Institute based on publicly available information from the PMDA, FDA, and EMA.

(6) Comparison of review periods for biopharmaceuticals between Japan, the U.S., and Europe

The presence of biopharmaceuticals has been increasing in recent years, and it is reported that they account for more than half of the top 100 drugs in the pharmaceutical market as a percentage of global sales in the previous report*10. We conducted a comparative analysis of approval periods and special measures for biopharmaceuticals in Japan, the U.S., and Europe.

Table 5 shows the review periods (in months) for biopharmaceuticals approved in Japan, the U.S., and Europe by year of approval (2013-2022) in the NME. In Japan, 137 biopharmaceuticals were approved as NMEs in the aggregate year, and the overall median review period was 10.3 months. In particular, 23 items were approved in 2022, following a record high of 24 items in 2021. In the U.S., 115 products were approved, with a median review time of 10.1 months for the aggregate year. In Europe, 160 products were approved, with a median review time of 13.6 months for the aggregate year. As a comparison, Table 6 shows the review time (in months) by approval year (2013-2022) in the NME for non-biotech drugs. Comparing the median review times for biotech and non-biotech drugs, the median review times in 2022 were similar in Japan (11.4 months and 10.4 months, respectively), while the median review times for biotech drugs were shorter in the U.S. and Europe, indicating that the impact of whether a biotech drug is approved or not on the review time was small. In both Japan, the U.S., and Europe, it can be said that the review period for biopharmaceuticals is expected to be about the same as that for non-biopharmaceuticals.

Table 5: Review Periods (in months) for Biotech Medicines (NME; 2013-2022)
Note 1: Figures in the previous published data may have been revised due to updating and recalculation of data in the cited materials.
Note 2: Five special approvals in 2021 and one special approval in 2022 are included in the number of approved items only because they are different from the normal review process.
Source: Prepared by the Pharmaceuticals and Industrial Policy Institute based on publicly available information from the PMDA, FDA, and EMA.

Table 6: Review Periods (in months) for Non-Biopharmaceuticals (NME; 2013-2022)
Note 1: Figures in previous published data may have been revised due to updating and recalculation of data in the cited materials.
Note 2: One special approval in 2020, one special approval in 2021, one special approval in 2022, and one emergency approval in 2022 are included in the number of approved items only because they differ from the normal review process.
Source: Created by the Pharmaceuticals and Industrial Policy Institute based on publicly available information from the PMDA, FDA, and EMA.

(7) Comparison of the number of approvals for regenerative medicine products between Japan, the U.S. and Europe

For the purpose of this report, the Japanese data does not include regenerative medicine products, as they are defined as drugs listed on the "List of New Drugs Approved" on the PMDA's website. In the U.S., the FDA's "CDER Drug and Biologic Approvals for the Calendar Year" does not cover products that are equivalent to regenerative medical products. In Europe, on the other hand, the data covers drugs listed in the "European Medicines Agency Annual Reports" and includes products that are equivalent to regenerative medicine products.

This section reports on the number of approvals in Japan, the U.S., and Europe in recent years for products that are equivalent to regenerative medicine products in Japan. For Japan, the products are those listed in the "List of New Approved Products for Regenerative Medicine, etc. " *11 on the PMDA website, and the number of items covers those listed as "approved" by approval/change. The period covered was from 2015, the year after the current Pharmaceutical Affairs Law came into effect. In the U.S., drugs listed in "Approved Cellular and Gene Therapy Products " *12 on the FDA website were counted based on the year in which they were first approved. In Europe, drugs approved by the EMA under the central review procedure and listed in the "European Medicines Agency Annual Reports" were included, and those approved under the Advanced therapy medicinal products (ATMP) *13 designation were included. The data are based on the "European Medicines Agency Annual Reports".

Figure 5 shows the number of new approvals (2015-2022) for products equivalent to regenerative medicinal products approved in Japan, the U.S., and Europe, and the number of products approved in Japan, the U.S., or Europe in two or more regions as of the end of 2022. In Japan, 15 products were newly approved from 2015 to 2022, including 7 products that were approved in either or both the US and Europe. The product names, year of approval and review period in each pole are shown in Table 7.

Nineteen and 20 products were newly approved in the U.S. and Europe, respectively, from 2015 to 2022, and 12 and 13 products were approved in two or more regions by the end of 2022, respectively. The number of newly approved products in both Japan, the U.S., and Europe is increasing, and the number of global products approved in more than one of the two regions is also increasing. Figure 6 shows the classification of diseases for which regenerative medical products were approved. Antineoplastic agents are the most common, and several products targeting the sensory organs and nervous system have been approved in Japan.

Table 7 compares the approval year and review period for regenerative medical products in Japan with those for the same products in Europe and the United States. Four of the seven products shown in Table 7 were approved in Japan within one year of the initial approval in the U.S. and Europe. In addition, five of the seven products received approval within 10 months, indicating that the review period for these products is expected to be as short or shorter than in the U.S. and Europe.

Figure 5 Number of newly approved regenerative medical products (2015-2022)
Source: Prepared by the Pharmaceuticals and Industrial Policy Research Institute based on publicly available information from PMDA, FDA, and EMA.

Figure 6 Disease classification of regenerative medical products
Source: Prepared by the Pharmaceuticals and Industrial Policy Research Institute based on publicly available information from PMDA, FDA, and EMA, and ATC classification in "New Drugs of Tomorrow (Technomic Production)

Table 7 Regenerative medicine products approved in Japan, the U.S., or Europe in two or more regions (total of 7 products)
Note: Figures in the past published data may have been revised due to updating and recalculation of data in the cited materials.
Source: Prepared by the Pharmaceuticals and Industrial Policy Institute based on publicly available information from PMDA, FDA, and EMA.

Conclusion and Discussion

In this report, we have compiled and surveyed the number of new drugs approved in Japan, the U.S., and Europe in 2022 and their review periods, based on information published by the regulatory authorities.

The number of new drug items approved in 2022 was high in Japan, the U.S., and Europe for the past eight years, both in terms of the total number of approved items and the number of NMEs, while the number of special regulatory actions was also at the same level as in 2021. In both Japan, the U.S., and Europe, the median review period for items that received special pharmaceutical measures was shorter than the median review period for normal review, indicating that the measures were effective.

The median review period for all items approved in Japan in 2022 was 9.4 months, the smallest in Japan compared to Europe and the United States. The fact that the review period to obtain approval in Japan is at least as long as in the U.S. and Europe is considered a very important factor in achieving rapid access to new drugs, and is expected to remain at the same level in the future. In addition, there were nine special approvals in 2021 in response to COVID-19, and seven special approvals and one emergency approval were also approved in 2022, indicating that the response to the COVID-19 epidemic has become more active and expedited.

On the other hand, the median review period for products approved in the U.S. in 2022 was 11.0 months for all approved products, which was similar to the average year, but the average was 19.5 months. Of the products approved in the U.S. in 2022, the median and average review times for products from companies with 10 or fewer products on the market in 2022 were 12.0 months and 20.0 months, respectively, compared with the median and average review times for other companies (10.5 months and 10.5 months, respectively). It is possible that the review period in 2022 may have been affected by the large number of approvals granted to companies with fewer products already on the market. In Europe, there is a regulatory support system for small companies, and the success rate of approval applications by these companies more than doubled between 2016 and 2020. 15 In addition to conventional face-to-face advice and pre-interviews, the PMDA has also launched a comprehensive consultation service mainly for universities, research institutes, and venture companies. In addition to the traditional face-to-face advice and pre-meeting, the PMDA also provides a comprehensive regulatory science consultation and regulatory science strategy consultation system, mainly for universities, research institutes, and venture companies*16.

Special measures for pharmaceutical affairs include the Pioneer Review Designation System, Breakthrough Therapy, and PRIME for drugs that are expected to be highly effective in treating serious diseases. However, the number of approvals under Japan's Pioneer Review Program was small compared to the number of Breakthrough Therapy and PRIME approvals in Europe and the United States. The impact of this on access to highly innovative drugs in Japan has not yet been analyzed, but in order to maintain and improve the same level of access to drugs as in the U.S. and Europe, it is possible that further efforts will be required in addition to making maximum use of the current special exceptions in the pharmaceutical affairs system.

Regarding the survey on biopharmaceuticals, the number of items was at a record high level in Japan, the U.S., and Europe as well as in 2021, and the review period was about the same regardless of biopharmaceuticals. The number of approvals for regenerative medicine products has been increasing in Japan, the U.S., and Europe in recent years, and the number of global products receiving approval in more than one of the two regions has also been increasing. The number of global products receiving approval in two or more regions (the U.S. and Europe) has also been increasing. Although there was some variation in the review period for each product, there was a trend for the review period in Japan to converge around 10 months. The fact that a certain review period can be expected regardless of the modality, such as biopharmaceuticals and regenerative medicine products, is considered important in terms of lowering the hurdles to the early launch of innovative drugs. In addition to maintaining the same or faster review process as in Europe and the U.S., flexibility in responding to innovative technologies and unforeseen circumstances such as COVID-19 is expected to be maintained in the future.

( Chie Yoshiura, Senior Researcher, Pharmaceutical and Industrial Policy Research Institute)

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