Expectations of the Pharmaceutical Manufacturing Industry for the International Strategies of MHLW and PMDA

Masafumi Nogimori President, The Federation of Pharmaceutical Manufacturers‘ Associations of JAPAN (FPMAJ) (Representative Director, Chairman of the Board, Astellas Pharma Inc.)

September 3rd, 2015

The Commemorative Lecture Meeting for International Strategies of MHLW/PMDA

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1 5 I n d u s t r i a l O r g a n i z a t i o n s 1 7 R e g i o n a l O r g a n i z a t i o n s

The Intravenous Solutions Society

Japan Ophthalmic Pharmaceutical Manufacturers Association

External Pharmaceutical Association

Japan Association of Vaccine Industries

Japan Self-Medication Industry

Japan Association of Clinical Reagents Industries

Japan Kampo Medicines Manufacturers Association

Japan Blood Products Association

Pharmaceutical Drug Processors Association

Japan Home-Delivery Medicine Association

Japan Generic Medicines Association

Home Medicine Association of Japan

Japan Direct-Selling Pharmaceutical Manufacturers Association

Japan Pharmaceutical Manufacturers Association Pharmaceutical Manufacturers Association of Tokyo

Osaka Pharmaceutical Manufacturers Association

Aichi Pharmaceutical Manufacturers Association

Toyama Pharmaceutical Manufacturers Association

Hyogo Pharmaceutical Manufacturers Association

Tokushima Pharmaceutical Manufacturers Association

Forum for Innovative Regenerative Medicine

Saga Pharmaceutical Manufacturers Association

Kanagawa Pharmaceutical Manufacturers Association

Nara Pharmaceutical Manufacturers Association

Nagano Pharmaceutical Manufacturers Association

Saitama Pharmaceutical Manufacturers Association

Ishikawa Pharmaceutical Manufacturers Association

Shiga Pharmaceutical Manufacturers Association

Gifu Pharmaceutical Manufacturers Association

Chiba Pharmaceutical Manufacturers Association

Pharmaceutical Manufacturers Association of Fukuoka

Niigata Pharmaceutical Manufacturers Association

Organization of FPMAJ

Contents

1. Japan experiences and efforts to become a “Reference Country”

2. Expectations for the “International Strategies” of MHLW and PMDA

– Asian Pharmaceuticals and Medical Devices Regulatory Training Center

– Clinical Innovation Network

– Regulatory Science Center

3. Further Japan contributions to global health and hygiene through the “International Strategies”

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Contents

1. Japan experiences and efforts to become a “Reference Country”

2. Expectations for the “International Strategies” of MHLW and PMDA

– Asian Pharmaceuticals and Medical Devices Regulatory Training Center

– Clinical Innovation Network

– Regulatory Science Center

3. Further Japan contributions to global health and hygiene through the “International Strategies”

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Japan’s National Health Insurance System

Japan’s National Health Insurance System was established in 1961 and has been maintained for over 50 years.

System assures equal access to a wide variety of health service, including innovative therapies, for the entire Japanese population.

• Quick access: within 60 days from regulatory approval to NHI price listing

• Free access: Everyone, Everywhere, With a fair price

Health expenditures have been remained 10th out of the OECD countries (10.3% of GDP) in despite of top aging population rate (24.1%) in 2012.

Source: OECD Health Data 2014

5

40

10 12

14

5 3

1

5 6

44

12 13

9

6

2 1

4 6

1

47

15

8 8 7

4 2 2 2 2

0

10

20

30

40

50

（品目数）

2003 2008 2013

Number of Medical Use Pharmaceutical Products Ranked in the Top 100 Global Sales by Country of Origin

Note: Categorization by nationality of patent holding company Based upon 2013 sales data of top 100 products by country of origin of company

Source: Based upon information obtained from © 2015 IMS Health. World Review, LifeCycle, Thomson Innovation, Pharmaprojects, EvaluatePharma (Copying and duplication prohibited) Source: Office of Pharmaceutical Industry Research Industry Report No. 5 (December 2014)

Japan is one of the countries which can originate and develop new drugs , ranked as the 3rd in the world and only one in Asia.

Number of Products

The ICH Steering Committee

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The ICH Steering Committee (SC) is the governing body that oversees the harmonisation activities of ICH. The SC has representatives from the six Founding Parties (EU, EFPIA, MHLW, JPMA, FDA, PhRMA), and from Swissmedic and Health Canada. Since the outset of ICH, WHO has participated as an Observer to the SC. The IFPMA participates as a non-voting member of the SC. (Source: Reprinted from ICH website)

Source: Reprinted from PMDA website

Japan has contributed to develop ICH guidelines as a funding member.

Drug Lag of Pharmaceutical Products Containing New Molecular Entities in Japan

8

Source: PDMA “Drug Lag Trial Calculation (FY2009-2013)”

(year)

Development Lag: Regarding to New Drug Applications which have been submitted within the corresponding fiscal year in Japan, the median of the time lag from the application in the United States Review Lag: Difference of the overall review period (Median) between the United States and Japan regarding NDAs in the corresponding fiscal year (Calendar year used in the United States) Drug Lag: Sum of development and review lags

Japan’s review lag has been virtually eliminated.

(Fiscal Year) 0

0.5

1

1.5

2

2.5

3

3.5

2009 2010 2011 2012 2013

Review lag

Development lag

Contents

1. Japan experiences and efforts to become a “Reference Country”

2. Expectations for the “International Strategies” of MHLW and PMDA

– Asian Pharmaceuticals and Medical Devices Regulatory Training Center

– Clinical Innovation Network

– Regulatory Science Center

3. Further Japan contributions to global health and hygiene through the “International Strategies”

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Expectations for Asian Pharmaceuticals and Medical Devices Regulatory Training Center

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RMP: Risk Management Plan, PMS: Post Marketing Surveillance

Promote diffusion of ICH guidelines

• Mutual usage of study results • Cooperate in review and audit • Eligible for abridged reviews

Earlier NDA and Approval in Asian Countries

• Promote Asian joint clinical trials • Accelerate development of orphan

drugs by Asian joint studies

Cooperate in proper uses and safety measures after launch in Asian countries (RMP PMS Safety Measures)

Expectations for Clinical Innovation Network

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• Extend the Disease Registry System to facilities in Asian Countries

• Site management by Clinical Innovation Network office

• Complete site selection with accurate forecast for patients enrollment in clinical trials by One-Stop service

• Rapid enrollment • Collection of robust clinical data with

efficient procedures

Promote Asian joint clinical trials with short period, low cost and high quality

Expectations for Regulatory Science Center

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• Research for pathology, prognostic factors, biomarkers etc. • Evaluate overall benefit and risk of drug classes • Specify responders and patients with risk factor for adverse

events

• Optimize clinical development plans and study protocols • Ensure safety measures and promote proper uses • Develop innovative guidelines to accelerate development,

which are well harmonized and accepted globally

Robust database from NDA data and MID-NET etc.

Improve predictability of efficacy and safety Accelerate to develop new therapies

Contents

1. Japan experiences and efforts to become a “Reference Country”

2. Expectations for the “International Strategies” of MHLW and PMDA

– Asian Pharmaceuticals and Medical Devices Regulatory Training Center

– Clinical Innovation Network

– Regulatory Science Center

3. Further Japan contributions to global health and hygiene through the “International Strategies”

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Trends and Forecasts of Elderly Population Composition in Japan and Countries in Europe, North America and Asia

15 Source: Reprinted from Annual Report on the Aging Society 2014 (Summary), Japan Cabinet Office

Japan faced on aging society the earliest in the world, increasing in elderly population.

Average Life Expectancies of OECD Countries (2013)

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Japan’s pharmaceutical products and medical database will be able to make a more contribution to improvement in health and hygiene and extension of healthy life expectancy in the world.

Source: Created from World Health Statistics 2015, World Health Organization

(years)

50

55

60

65

70

75

80

85Life expectancy

Healthy life expectancy

Healthy life expectancy in Japan is the longest in the OECD members.

Annual Trend of Medical Use Pharmaceutical Product Market Share by Country or Region

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38.6% 38.3% 36.7% 36.6% 36.8%

10.8% 10.8% 11.6% 11.7% 9.6%

5.0% 4.7% 4.6% 4.4% 4.7%

4.9% 4.3% 4.1% 3.8% 3.8%

3.3% 3.0% 3.0% 2.7% 2.8%

3.3% 3.0% 3.0% 2.7% 2.8%

14.1% 13.3% 13.1% 12.3% 12.5%

6.4% 7.3% 7.4% 7.7% 7.7%

14.6% 16.1% 17.4% 18.5% 19.5%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

2009 2010 2011 2012 2013

アジア (日本を除く) ･ アフリカ・オセアニア

中南米

その他ヨーロッパ

イギリス

イタリア

フランス

ドイツ

日本

北米（アメリカ・カナダ）

Source: Created from World Review 2014, ⓒ 2015 IMS Health (Unauthorized duplication, publication prohibited) Source: Japan Pharmaceutical Manufacturers Association, Data Book 2015

Pharmaceutical product market share of Asia (except Japan), Africa, Oceania area is on the rise.

Asia (except Japan), Africa, Oceania Asia (except Japan), Africa, and Oceania Asia (except Latin America

Europe (Others)

United Kingdom

Italy

France

Germany

Japan

North America (USA, Canada)

In Conclusion,

The International Strategies of MHLW/PMDA are expected to promote earlier access to pharmaceutical products for patients in the world.

Closer collaboration and further harmonization with foreign regulatory agencies will be accelerated by PMDA’s continuous leadership and efforts.

In order that Japan can become a “Reference Country”, the pharmaceutical industry will go along with the strategies and cooperate with MHLW/PMDA.

Realize regulatory harmonization on global level and aim for simultaneous market launch globally.

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Thank you for your attention!

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FPMAJ