The Pharmaceutical Industry at a Glance Comparison of the launch status of the top 300 pharmaceutical products in the world in terms of sales in Japan, the U.S. and Europe

Akira Nakao, Senior Researcher, Pharmaceutical and Industrial Policy Research Institute

1. Introduction

The Pharmaceutical Industry Research Institute (PIRI) conducted a survey in its Policy Research Institute News No. 57 on the status of the launch of the world's top 300 pharmaceutical products in terms of sales in Japan, the U.S., and Europe in fiscal 2017 and the difference in launch timing between Japan, the U.S., and Europe. ¹⁾ In the survey, the top 300 products in terms of sales were listed in Japan, the U.S., and Europe. The survey found that only about 20% of the top 300 products in terms of sales have not yet been launched in Japan, a higher percentage than in the U.S. and Europe, and that many of the products that have been launched in Japan are the third most launched products after the U.S. and Europe. The author reports that the drug lag in Japan has been improving in recent years in this respect.

In this study, the author used the Evaluate Pharma database, as in the previous study, to investigate the status and timing of launches in Japan, the U.S., and Europe of the top 300 products in terms of sales in FY2021, and analyzed what changes have occurred over the past four years, and what products are included among those that have not yet been launched in Japan. The analysis was conducted on the status and timing of product launches in Japan, the U.S. and Europe for the top 300 products.

2. overview of the top 300 products in terms of sales

Figure 1 Characteristics of the top 300 products in terms of sales by drug category and technology category (FY2017 and 2021)

Before discussing the launch status and timing, an overall overview of the top 300 products in terms of sales, including changes from FY2021 and the previous survey (FY17), is provided, along with a summary of their drug class, technology class, and launch timing.

Figure 1 shows the top 300 products in terms of sales, broken down by therapeutic category (EphERA ATC code1) ²⁾ and technology category. The number of products in Classification J decreased by 3 products, but a total of 10 products of vaccines and therapeutics related to COVID-19 infection were added, while the number of products in Classification HCV, HCV, HIV, and HIV/AIDS products increased by 2 products. The number of HCV and HIV drugs decreased from 20 to 13 (Fig. 1, left).

The number of small molecule drugs decreased significantly from 192 to 158, while the number of antibody drugs increased significantly from 33 to 57, CAR-T recombinant cell therapy, bringing the total to four products, confirming the expansion and diversification of ^modalities3) (Figure 1, right).

Figure 2 Distribution of launch dates of top 300 products in terms of sales (FY2017 and 2021)

The top 300 products in terms of sales (FY17 and FY2021) were summed up by year of ^launch4) for each of the six years (combined for FY1979 and earlier) (Fig. 2). The periods with the largest number of products were 2004-2009 and 2010-2015 for FY 2017 and FY 2021, respectively. When products were ordered by year of launch from oldest to youngest, the 150th product was launched in 2004 and 2009, respectively, and in both years, the median time period around the launch was 12-13 years after launch (data omitted) ⁵⁾.

3) Launch status of the top 300 products in Japan, the U.S., and Europe in terms of sales

Figure 3 Comparison of the number of product launches in Japan, the U.S., and Europe for the top 300 products in terms of sales in FY2021

Figure 3 shows the status of the top 300 products in terms of sales in Japan, the U.S., and Europe in FY2021 by product (Figure 3). Approximately 80% (79%) of all products were launched in all of Japan, the U.S., and ^Europe6), an increase of approximately 4 percentage points from ^75%1) in FY2017. 12% of drugs were launched in the US and Europe excluding Japan, and 4% were launched only in the US.

Figure 4 Comparison of the number of launches of the top 300 products by sales in Japan, the U.S., and Europe in FY2021 - by region

In Japan, 82% of the top 300 products in terms of sales were launched (53 products were not yet launched), in the U.S. 96% were launched (12 products were not yet launched), and in Europe 92% were launched (24 products were not yet launched) (Figure 4 left). As for Japan, the number of launched products increased by 8 points from 239 ^products1) to 247 products in FY2017, but there was a large gap in the number of products launched compared to the US and Europe.

The breakdown of the top 300 products in terms of sales was 133 biopharmaceutical products and 167 non-biotech ^products7) (87 biopharmaceutical products in ^FY20178) ), In Japan, 88% (113/133) of biotech products were launched, a higher launch rate than the 80% (134/167) of non-biotech products. The same trend was observed in the U.S. and Europe (U.S.: 97% biotech, 95% non-Bio; Europe: 95% biotech, 90% non-Bio), with biotech drugs having a higher launch rate than other drugs (Figure 4 center to right).

4. launch ranking of top 300 products in Japan, the U.S., and Europe in terms of sales

Fig. 5 Ranking of Japan-U.S.-Europe launches of top 300 products by sales in FY2021

The order in which the top 300 products in terms of sales in FY2021 were launched in Japan, the U.S., and Europe was investigated (Fig. 5, top). In the U.S., 65% of the products were launched first, 26% were launched second, and 5% were launched third in Japan, the U.S. and Europe. In Europe, 31% of products were launched first, 51% second, and 10% third in Japan, the U.S., and Europe. The 300 products were divided into biotech (133 products) and non-biotech (167 products) and their launch ranking was compared. There were no significant differences between the 300 biotech and non-biotech products in terms of market launch ranking (Figure 5, bottom). These results suggest that the most common pattern for top-selling drugs is to be launched first in the U.S., followed by Europe, and then Japan, and this trend was the same as four years ago (FY2017).

5. difference in timing of Japanese product launches compared to the U.S. and Europe

Fig. 6 Difference between the launch dates of the top 300 products by sales in Japan and those in the U.S. and Europe in FY2021

Fig. 7 Difference between launch dates in Japan and the U.S. and Europe for the top 300 products in terms of sales (comparison between FY2017 and FY2021)

The difference in actual launch timing between Japan and the U.S. and between Japan and Europe was calculated for each product and their trends were investigated (Figure 6). This item covers 241 and 239 products that were launched in Japan and the U.S., or in Japan and Europe, respectively.

Regarding the difference in launch timing between Japan and the U.S., 21% (51 products) were launched more than 5 years later in Japan than in the U.S., and 18% (44 products) were launched 3 to 5 years later, which together accounted for 39% (95/241 products) of the total. On the other hand, 24% (57/241 products) were launched in Japan less than one year later than in the U.S. (Figure 6 left). Although the proportion of drugs that were launched more than three years later in Japan is still significant at around 40%, this is a decrease of 9 percentage points from 48% (108/227 products) and 18% (41/227 products) that were launched more than three years later and less than one year later than in the U.S. ¹⁾ in the previous survey (FY2017), respectively, and a decrease of 6 percentage points over the past four years. (48% (108/227 products)) and 18% (41/227 products) were launched with a delay of less than one year1), resulting in a 9-point decrease and 6-point increase, respectively, over the past four years (data omitted).

Similar results were obtained for the difference in launch timing between Japan and Europe (Fig. 6, right). The percentage of products launched more than three years later in Japan than in Europe was 34% (81/239 products, down 10 points from 44% (101/229 products) ¹ in the previous survey), and the percentage launched less than one year later in Japan than in Europe was 25% (60/239 products, up 7 points ^from 18% (41/229 products) ¹ in the previous survey) (data omitted). (60/239 products, up 7 points from 18% (41/229 products)1) in the previous survey (data omitted).

However, it should be noted that the survey on the difference in launch timing between Japan and the U.S. and Japan and Europe only included products that were launched in both regions, and that products launched in any of the "Europe" countries were considered "launched" in Europe. ⁶⁾ It should be noted that the survey only covered products that were launched in both regions.

Next, we compared the difference in the timing of market launch between Japan and the U.S. and Europe between FY17 and FY2021 (Figure 7).

The median and average difference in the timing of the launch of 227 products that were launched in both Japan and the U.S. in the FY17 survey was 2.84 and 3.79 years, respectively. On the other hand, the median and mean difference in launch dates for the 241 products covered in the FY2021 survey was 2.22 years and 3.29 years, respectively, indicating that the difference in launch dates (median and mean) tended to decrease from FY17 to FY2021 (Figure 7, left).

The median and average difference in launch timing for the 229 products launched in Japan and Europe in the FY2017 survey was 2.59 and 3.80 years, respectively, while the median and average difference in launch timing for the 239 products in question was 1.76 and 3.12 years, respectively, in FY2021. The median and average difference in the timing of product launches between Japan and Europe also tended to narrow (Figure 7, right).

Figure 8 Relationship between FY2017 products and FY2021 products in the top 300 products in terms of sales

We conducted a factor analysis of the trend of narrowing of the difference (median and average) in the timing of market launch between Japan and the U.S. and between Japan and Europe from FY2017 to FY2021. Specifically, products were divided into those that were out of the top 300 products in terms of sales from FY2017 to FY2021 (A) and those that were not included in the top 300 products in terms of sales in FY2017 but ranked in the top 300 products in FY2021 (B) (Figure 8), and were launched in both Japan and the US, (Figure 8). The comparison of the difference in launch timing between Japan and the U.S. and Europe was made for products that had been launched in both Japan and the U.S. and products that had been launched in both Japan and Europe.

Figure 9 Comparison of the difference in launch timing between Japan and the U.S. and Europe for the top 300 products in terms of sales in FY2017 and FY2021 - ranked-out products and ranked-in products

First, we analyzed the difference in launch timing between Japan and the U.S. （The median difference between Japan and the U.S. for the 61 products ranked out in 2021 was 3.51 years, and the mean difference was 4.19 years. The median difference between Japan and the U.S. for the 67 products ranked in 2021 was 1.02 years and the mean was 1.74 years, confirming a significant difference between the means of these two groups (t-test p=0.0001, STATA v.13.1) (Figure 9 left).

The same analysis was performed for the difference in timing of market launch between Japan and Europe. （The median difference between Japan and Europe for the 63 products ranked out in 2021 was 3.40 years, and the mean difference was 4.26 years. The median difference between Japan and Europe for the 67 products ranked in 2021 was 0.32 years and the mean was 1.14 years, confirming a significant difference between the means of these two groups (t-test p=0.0001, STATA v.13.1) (Figure 9 right). It is thought that many of the new products ranked in the top 300 products in terms of sales are new drugs (including new indications added) that were launched in a year not too far from the survey ^year9), suggesting that such products have a small difference in launch timing (launch lag) between the US, Europe, and Japan.

6. drugs originated by Japanese companies

Figure 10: Launch status of drugs originated in Japan (31 products) among the top 300 products in terms of sales

We conducted a similar study of launch rankings and timing differences by focusing on drugs originated by Japanese companies. The term "originator" here refers to the "originator" as defined by the Evaluate Pharma database, and the nationality of the originator is the nationality of the company listed in the database10) . The nationality is the nationality of the company listed in the ^database10).

The number of Japanese originators was 31 (10.3%) out of the top 300 products in terms of sales. Similar to the launch order of the 300 products as a whole, the largest number of products were launched in the U.S. first, accounting for 55% of the total (56% in the previous ^survey1). On the other hand, 11 products (35%) were launched in Japan first (32%1 in the previous survey). In the overall ranking of 300 products, 5.7% (17 of 300 products) were launched first in Japan, indicating that Japan-origin products were relatively more likely to be launched first in Japan, and the tendency to launch first in the U.S. was the same as in the previous survey (Figure 10, left).

The median and average difference in launch timing between Japan and the U.S. and between Japan and Europe for drugs originating in Japan and those originating in countries other than Japan was 0.63 years and 0.60 years, respectively (26 products) for products originating in Japan and the U.S. The median and average difference in launch timing for products originating in Japan was 0.63 years and 0.60 years, respectively (26 products) for products originating in countries other than Japan and the average difference in launch timing for products originating in Japan and the U.S. was 2.2 years. The median and mean difference (median and mean) between Japan-origin products and European-origin products was 0.63 years and 0.60 years, respectively (26 products in the sample). The median and mean difference between Japan and Europe was 0.05 years and 0.50 years for Japanese origin products (26 products) and 2.10 years and 3.44 years for non-Japanese origin products (213 products). Significant differences between the means of the two groups, Japanese origin and non-Japanese origin products, were confirmed in both the U.S. and Japan/Europe cases (t-test p=0.0001, STATA v.13.1). For drugs originated by Japanese firms, there was little difference (lag of less than one year) between the U.S. and Europe with respect to drugs that are among the top 300 products in terms of sales (Figure 10, right).

7. products not launched in japan among top 300 products in sales

Figure 11: Products Not Launched in Japan as a Percentage of the Top 300 Products in Sales (FY 2017 and FY 2021)

As mentioned earlier, the number of products not yet launched in Japan among the top 300 products in terms of sales was 61 in FY17 and 53 in FY2021. Here, we conducted additional research on those products, especially those not yet launched in Japan in this survey.

The top 300 products not yet launched in Japan in terms of sales in FY 2017 and FY 2021 were organized according to their ATC1 drug classifications. As a result, many of the products not yet launched in Japan were in the J classification (general systemic anti-infectives) and the N classification (central nervous system drugs) (Figure 11).

The survey on the contents of efficacy categories for products not yet launched in Japan in FY2021 revealed that J category mainly covers infectious disease vaccines, plasma component drugs, and therapeutic drugs for infectious diseases, while products not yet launched in FY2021 include seasonal influenza vaccines (3), multi-species combination vaccines (3), and immunoglobulin products (3), vaccines and therapeutic antibodies against novel corona (2), hepatitis-related vaccines (2), meningitis vaccines (1), and varicella vaccines (1).

As for the N classification, 5 of the 10 products were indicated for multiple sclerosis, and the rest were drugs for Lennox-Gastaut syndrome and Dravet syndrome, anti-narcolepsy drugs, Huntington's disease drugs, and others. Four of the diseases listed here are designated as intractable diseases in Japan.

Of the six products in the R category (respiratory drugs), three were COPD or asthma drugs, one of which was a generic product (the brand name was already marketed in Japan). The remaining three products were drugs for cystic fibrosis.

Of the six products in the L category (anti-cancer agents and immunomodulators), one was a product used for autoimmune diseases (including multiple sclerosis), the remaining five were anticancer agents, one was a biosimilar (the brand name has been launched in Japan), one was currently under development in ^Japan11), and the remaining three were anticancer agents developed and marketed mainly in China. The remaining three products were anticancer drugs developed and marketed mainly in China, and were not approved by the regulatory authorities in Japan, the U.S., and Europe.

We would like to discuss the categories (formulations, vaccines, and diseases) in which multiple products were included among the products not launched in Japan in FY2021. Regarding plasma component products, it was considered that many overseas products were not yet marketed (unapproved) in Japan because the basic principle of the "Act on Securing Stable Supply of Safe Blood Products" is to ensure domestic ^{self-sufficiency12)}.

In Japan, the problem of the so-called "vaccine gap" has arisen due to the fact that the government has been required to take a cautious approach to vaccination administration against the background of the problem of adverse health reactions to ^{vaccination13)}. 13 ⁾ For example, for seasonal influenza vaccines, the scheme for selecting strains from the World Health Organization (WHO) list of recommended strains differs between Japan and other countries. ¹⁴⁾ Various factors have combined to delay the introduction of foreign-made vaccines into Japan.

As for diseases, two diseases (multiple sclerosis and cystic fibrosis) have been designated as designated intractable diseases in Japan, but overseas, for example, it is reported that more than 2.8 million people are currently affected by multiple sclerosis, ^{15) 16)} and cystic fibrosis is very rare in Asia, including Japan. 16 ⁾ In addition, cystic fibrosis is a rare disease in Asia, including Japan, while in Europe, it is one of the rare diseases with a relatively large number of patients, affecting approximately 1 in 3,000 live ^births17).

8. summary and discussion

In this report, we surveyed the status of the top 300 global pharmaceutical products in terms of sales in Japan, the U.S., and Europe in FY2021 and the timing of their launches, including changes from FY17.

Although the number of products ranked in the top 300 products in terms of sales that have not yet been launched in Japan has been decreasing over the past four years, approximately 20% of all products have not yet been launched, which is a higher percentage than in the U.S. and Europe. The trend of products that have been launched in the U.S. first, followed by those in Europe, and then those in Japan was similar to the previous survey. On the other hand, the percentage of products for which the difference in launch timing (launch lag) between the U.S., Europe, and Japan is considered to be significant decreased. The reason for this was considered to be the significant reduction in the lag between the launch of products that were launched in Japan in recent years and ranked in the top 300 products in terms of sales.

While the U.S. remains the number one market for products originating in Japan, the number of products launched first in Japan has also increased slightly since the previous survey. The lag time for the launch of Japanese-origin products was less than that of non-Japanese-origin products, and the gap between the two tended to be shorter than in the previous survey.

The following discussion is based on the differences from other previous studies on drug lag and losses. The difference in the timing of the launch of the top 300 products in terms of sales between Japan and the US/Europe tended to narrow from FY17 to FY2021. In Policy Research Institute News No. 63, Shibukuchi reported that the median difference in launch dates between the U.S. and Europe for new active pharmaceutical ingredients (NME) approved in Japan from 2010 to 2020 has been shrinking in recent ^years18). In addition, the Pharmaceuticals and Medical Devices Agency (PMDA) reported in a paper that "drug lag still exists, but it is decreasing significantly" ⁽¹⁹⁾.

These earlier papers and the survey of the difference in the timing of market launch between Japan and the U.S./Europe in this paper cannot be compared because of the difference in the subject matter of the surveyed products. The top 300 products in terms of sales discussed in this paper are a collection of the world's best-selling drugs, and to be ranked in the top 300, a product must have sales of approximately US$500 million in FY17 and approximately US$600 million worldwide in FY2021 (based on company reporting). Although there are cases of co-marketing, sales of approximately $600 million for a single product are products that are close to so-called blockbusters, and it can be imagined that many of these products were developed simultaneously around the world, with the high profitability of these products anticipated from the beginning of their development. This suggests that the lag time for the launch of the world's top 300 products in terms of sales has been shortening in recent years.

Next, in the survey of products not yet launched in Japan, the number of drugs not yet launched in Japan showed a decreasing trend from ^the 2017 ^survey1). In a report on "drug lag " ^{20),21 which} Yoshida et al. have been continuously surveying and analyzing, it is reported that the percentage of drugs approved in the U.S. and Europe that are not approved in Japan has been increasing since the late 2010s. Although this is a different trend from the results of this survey of the top 300 products in terms of sales, as mentioned earlier, the top 300 products in terms of sales are a collection of the best-selling drugs in the world. In addition, it takes a certain number of years for a drug to be launched and penetrate the market, and half of the top 300 products in FY2021 were launched in 2009 or earlier.

These factors suggest that there is a difference in the output between the survey of products not yet marketed in Japan, which covers the top 300 products in terms of global sales, and the survey of products not yet approved in Japan, which covers all NME-approved products in Europe and the US in recent years (from 2010 onward). This survey should be closely monitored for future trends on a 5-10 year basis.

Finally, the additional survey of products not yet marketed in Japan revealed that one of the characteristics of products not yet marketed in Japan includes blood products, various vaccines, and drugs for diseases for which the number of patients in Japan is small but the percentage of patients overseas (especially in Europe and North America) is large. Yoshida, Iida et al. reported that the percentage of orphan drugs in Japan's unapproved drugs is increasing, and that one of the reasons for this increase is that more and more drugs are being developed by emerging biopharmaceutical companies overseas, which are not prioritized in the Japanese ^{market20)-22)}.

Nakamura et al. and Imai et al. found a significant positive association with "expected sales (expected market size)" in Japan as a factor shortening the development time of existing Japanese-approved drugs in their study of background factors behind the delay in new drug development in Japan relative to the U.S. ^23)-24).

However, when we look at the profitability in Japan, we find that products with low profitability, such as those with a small number of patients, are likely to be unapproved in Japan, even if they are ranked in the top 300 products in terms of global sales. The profitability of the Japanese business is a problem for the drug laundry industry. The issue of profitability of the Japanese business was suggested as one of the unresolved issues of drug lag and drug loss.

Conclusion

The top 300 products in terms of sales include a certain number of products that have not yet been launched in Japan, which may include products that satisfy unmet medical needs of patients living in Japan. In addition, the top 300 products in terms of sales represent only a handful of the drugs marketed worldwide, and there are many other products that have not reached the patients who need them because their launch in Japan has been delayed, undeveloped, or ^{discontinued20)-22)}. As one of the efforts to eliminate the drug lag, the MHLW's "Review Committee on Unapproved and Off-label Drugs of High Medical Need" was launched in 2010, and has met 53 times to date, with a total of more than 300 products approved by the end of December 2022, helping to eliminate unapproved ^{drugs20 (25)}. In addition, it has been pointed out that the introduction in FY2010 of an additional subsidy system to promote the creation of new drugs and the elimination of drug lag as an incentive to develop innovative new drugs and eliminate drug lag may also be contributing to the elimination of drug ^lag18). However, the recent increase in the percentage of unapproved drugs in Japan has made it imperative to consider further measures to eliminate the drug lag (loss).

The Ministry of Health, Labor, and Welfare's "Expert Panel on Comprehensive Measures to Achieve a Rapid and Stable Supply of Pharmaceuticals" ⁽ MHLW ²⁶⁾, which began in August of last year, has taken up the issue of drug lag (loss), and has held hearings with pharmaceutical-related industries to discuss how to resolve this issue.

It is hoped that industry, academia, and government will work together to take the next step toward solving this problem so that patients and healthcare professionals who are waiting for new drugs will be able to access new drugs promptly and without being left behind.

1) Number of reports and countries from which data was obtained

Pharmaceutical and Industrial Policy Research Institute, "Comparison of the Launch Status of the World's Top 300 Products by Sales in Japan, the U.S., and Europe: Is the Drug Lag Being Resolved?", Policy Research Institute News No. 57 (July 2019).
2)

The European Pharmaceutical Market Research Association (EPHMRA) EphMRA ATC code1 from the Evaluate Pharma database was used.
3)

Due to a review of Evaluate Pharma's technology classification TECHNOLOGY section, we reexamined its technology classification for the top 300 products in sales in FY 2017 and compared them to the 300 products in FY 2021.
4)

The launch date here is the calendar year of the first product launched worldwide, not only in Japan, the U.S., and Europe (Evaluate Pharma's First Launch (WW)).
5)

The launch years for the three products with unknown launch dates in FY2017 were tentatively counted as 1979 or earlier.
6)

Information on launches is current as of October 11, 2022. Europe" here refers to "France, Germany, Italy, Spain, Switzerland, Turkey, the United Kingdom, and other European countries," which is defined as "Europe" by Evaluate Pharma. Note that the term "launched" refers to a product when it is launched in one of these countries, and not in all European countries.
7)

Biopharmaceuticals include "antibodies (including genetically modified organisms)," "proteins and peptides," "vaccines," and "nucleic acids, genes, and recombinant cell therapy," as shown in Figure 1 (right). Non-biologics include "small molecules (including plant extracts and in vivo diagnostics)" and "plasma-derived components.
8)

Evaluate Pharma's classification definition of biopharmaceuticals (corresponding to biotechnology in the Technology category) was changed from the previous survey to the current survey. If the 300 products in the previous survey are recounted using the current definition, the number of biotech products is 95.
9)

（The median and average year of launch in the U.S. for the 61 products in (A) that were launched in both Japan and the U.S. were 2002 and 2003, respectively, while the median and average year of launch in Europe for the 63 products that were launched in both Japan and Europe were 2002 and 2004. On the other hand, the median and mean US launch years for the 67 products in (B) that were launched in both Japan and the US were 2016 and 2017, respectively, and the median and mean European launch years for the 67 products that were launched in both Japan and Europe were 2016 and 2018.
10)

Evaluate Pharma defines an Originator as "a company that first discovered/invented a compound or product's active ingredient in relation to a product. In some cases, multiple Originators are designated for products that combine multiple active ingredients or where the active ingredient was co-discovered by more than one company. In this report, when multiple companies are listed in the Originator and one or more of them is a Japanese company, it is counted as a drug product with a Japanese originator.
11)

According to New Drugs for Tomorrow (Technomic Co., Ltd.). (Reference date: January 30, 2023).
12)

Ministry of Health, Labour and Welfare, "Act on Securing Stable Supply of Safe Blood Products" (reference date: January 30, 2023).
13)

Ministry of Health, Labour and Welfare, "Basic Plan for Immunization" (reference date: January 30, 2023).
14)

Ministry of Health, Labour and Welfare, 31st Meeting of the Subcommittee on Immunization and Vaccine of the Health Sciences Council, Subcommittee on Research and Development and Production and Distribution, Document "Process (Draft) for Selection of Overseas Influenza Vaccine Production Strain" (January 25, 2023) (referenced on January 30, 2023).
15)

Multiple Sclerosis International Federation (MSIF) (reference date January 30, 2022).
16)

In Japan, the criteria for designation as an orphan drug, etc. are met as the number of subjects. From the website of the National Institute of Biomedical Innovation, National Institute of Health and Nutrition, Website of the Project for the Promotion of Rare Drug Development, etc. (Reference date: January 30, 2023).
17)

Research Group for Improving the Standard of Medical Care and Patient Quality of Life in Rare and Intractable Childhood-Onset Hepatobiliary and Pancreatic Diseases, Cystic Fibrosis (reference date: January 30, 2023).
Pediatric Chronic Specified Disease Information Center 8. Cystic Fibrosis (Reference date: January 30, 2023).
18)

Pharmaceutical and Industrial Policy Research Institute, "Drug Lag: Status of Launch of NME-Approved Products in Japan Compared to the U.S. and Europe," Policy Research Institute News No. 63 (July 2021).
19)

Tanaka M, et al, "Evolving Landscape of New Drug Approval in Japan and Lags from International Birth Dates: Retrospective Regulatory Analysis", Clin Pharmacol Ther. 2021, 109(5), 1265-1273.
20)

Pharmaceutical and Industrial Policy Research Institute, "Drug Lag: Status and Characteristics of Unapproved Drugs in Japan," Policy Research Institute News No. 63 (July 2021).
21)

Drug Lag: Can Unapproved Drugs Meet Japan's Unmet Medical Needs?" Policy Research Institute News No.66 (July 2022), "Drug Lag: Comparison of the Situation of Unapproved Drugs in Japan and Europe," Policy Research Institute News No.67 (November 2022), "Quantitative Analysis of the International Diffusion of New Drugs: Focusing on the Japanese and European Approval of New Drugs Approved in the United States," Policy Research Institute News No.67 (November 2022).
22)

Pharmaceutical and Industrial Policy Research Institute, "Drug Lag: Why Are Unapproved Drugs Increasing?" Policy Research Institute News No. 66 (July 2022).
23)

Nakamura H, Wakutsu N, Murayama S, Suzuki T," An Empirical Analysis of Japan's Drug Development Lag Behind the United States " The Journal of Clinical Pharmacology 2022, 62(7), 847-854.
24)

Yuya Imai and Mamoru Narukawa, "A Study on the Background of New Drug Development Delay in Japan," The Journal of Regulatory Science Vol. 12 No. 3, 235-245 (September 2022).
25)

MHLW Study Council on Unapproved and Off-label Drugs of High Medical Need (Reference date: January 30, 2023).
26)

Ministry of Health, Labour and Welfare, Expert Panel on Comprehensive Measures to Achieve Prompt and Stable Supply of Pharmaceuticals (Reference date: January 30, 2023).

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