Navigating the Regulatory Environment in Asia Regulatory convergence under existing individual country specific requirements

4th June 2014

3

Introductions

Hye Jin ChoiSenior Director, Regulatory Affairs and Study Start Up, APAC, ICON Clinical Research

Hye Jin Choi has over 20 years’ experience in the Clinical Research industry. Currently, she is responsible for the Study Start Up and Regulatory operations across Asia Pacific region at ICON Clinical Research. She has extensive regulatory project management and product development experience in a number of therapeutic areas including CNS, immunology, endocrinology, infectious diseases, oncology, hepatology, osteoarthritis, infertility and cardiology. Hye Jin has successfully achieved global submissions and registrations of NCEs and conducted import drug registration of NCEs/biologics in China.

4

Introductions

Kerwin LowHead of Regulatory Affairs for the International an d LatAmRegions, Novartis Vaccines

Kerwin has over 10 years of experience in International Regulatory Affairs. He previously held roles in GlaxoSmithKline leading Asia Pacific regulatory affairs for Pharmaceuticals and Vaccines, and in Johnson & Johnson where he was Asia Pacific regulatory Affairs Director for their Medical Device division. He also has experience as a regulator, having worked for 5 years with the Singapore Health Sciences Authority, including roles leading the Drug Registration and Clinical Trial branches of the agency. Kerwin holds a PhD degree in pharmacology from the National University of Singapore.

5

Agenda

• Recent Regulatory Convergence Efforts across Asia

Pacific

• Approaches to Pan Asia Trial Regulatory Strategy

• Bridging Data Package Requirements to support NDA

• Vaccines Development

• Recent Developments in APEC RHSC (Regulatory

Harmonization Steering Committee)

• Risk/Benefit Assessment

Age

nda

A recording of this Webinar is also available

To view click on the link below http://www.iconplc.com/webinar/14/NavigatingtheRegulatoryenvironmentinAsia.wmv

1

Recent Regulatory Convergence Efforts - AsiaPacChina-Korea-Japan Tripartite Alliance, China & Taiwan Regulatory Authority Interactions, ASEAN Harmonization

7

Regulatory Cooperation and Convergence Initiatives

1. ObjectivesTo share expertise to improve the quality of reviews and to promote consistent approaches to the protection of patient health in a scientifically complex and global healthcare market

2. Examples are;• China-Japan-Korea Tripartite Cooperation• Association of Southeast Asian Nations (ASEAN) Common Technical Document

dossier guidelines• China and Taiwan “Cross Strait Medical and Health Care Cooperation Agreement” • International Regulators Consortium (TGA of Australia, Health Canada,

Swissmedic of Switzerland, Health Sciences Authority of Singapore)• Asia-Pacific Economic Cooperation (APEC)• International Serious Adverse Events Consortium (iSAE)• South Asia Benefit-Risk Evaluation (SABRE) framework• US FDA Asia-Pacific International Program

8

China-Japan-Korea Tripartite Cooperation

1. Objectives1) To promote MRCT (Multi-Regional Clinical Trial) 2) To facilitate drug approval process3) To address growing needs for mutual recognition of clinical data

2. Summary of Milestone Meetings and Outcomes• 2007 (Seoul, Korea): China-Japan-Korea Tripartite Health Ministers Meeting • 2008 (Tokyo, Japan): 1st China-Japan-Korea Director General Meeting – setting

direction for agenda, establishment of Working Group, retrospective literature study began collecting available PK data from Chinese, Japanese and Koreans for data analysis

• 2009 (Beijing, China): 2nd China-Japan-Korea Director General Meeting –research initiated in Japan for prospective PK study to compare/analyse potential ethnic differences

• 2010 (Seoul, Korea): 3rd China-Japan-Korea Director General Meeting –detailed discussions around ongoing program, Concept Paper for the project

• 2011 (Tokyo, Japan): 4th China-Japan-Korea Director General Meeting –interim report on Research of Ethnic Factors in PK data (by Japan), Information Exchange Project on clinical data etc. of 3 countries (by Korea), guideline on regional clinical trials (proposed by China)

9

China-Japan-Korea Tripartite Cooperation

1. “Study to investigate the feasibility on sharing the clinical data in Korea, China and Japan”

1) Investigator site: Seoul National University Hospital upon request from MFDS2) Study period: 15 Jan 2011 to 30 Nov 20113) Scope of study

- To investigate genetic polymorphism of drug metabolizing enzyme, transporters, and frequency of those variants

- To exhibit selected allele, genotype, haplotype which were determined to be different - To conduct prospective pharmacogenomic study regarding genetic variants- To conduct population pharmacokinetic (PK) analysis (selected 5 marketed drugs)- To generate population PK analysis plan/report and draft guidelines on such evaluation

4) Published study results claiming on its limitation- “We could not detect genetic variants that DMET Plus cannot cover”, limited sample- Epigenetic external factors were not examined- Population PK analysis was conducted using only Korean and Japanese data- Contributed in establishing a database for genetic variants among Chinese, Japanese

and Koreans

10

Japan: PMDA Provides Updated Guidance on Conducting Global Clinical Trials

1. “Basic Principles on Global Clinical Trials” issued on Sep 28, 2007 to encourage Japan’s participation in Global Clinical Trials (GCTs) from an early stage of drug development

2. “Basic Principles on Global Clinical Trials (Reference Cases)” issued on Sep 5, 2012

3. PMDA recommends the use of the document, Basic Principles on Global Clinical Trials (Reference Cases), September 5, 2012 prior to engaging the agency in consultations

- Consists of 17 Q&As : 4 points to consider for global clinical trials in East Asia,13 general points to consider on global clinical trials

1) Special points to consider for global clinical trial in East Asia2) Recommended therapeutic areas3) Global drug development strategy plan based on data of inter-ethnic comparison of PK profiles4) Points to consider for East Asian clinical trial as a bridging study

11

Japan: PMDA Provides Updated Guidance on Conducting Global Clinical Trials

1. Basic Principles on Global Clinical Trials (Reference Cases)

Points to consider for global clinical trials in East Asia (continued)

1) Data from well-designed and well conducted GCTs in East Asia is acceptable

2) GCTs in East Asia need to be designed and conducted based on prior evaluation of ethnic difference

3) Further accumulation of experience will lead to improvement of the efficiency and quality of clinical development in East Asia

4) Although GCTs in East Asia can be performed for any target disease area, they may contribute to the improvement of the efficiency and quality of development of drugs especially for diseases with high morbidity in East Asia

5) Development plan may depend on the comparison of the PK profile between Japanese & Caucasian / Japanese & other East Asian populations

6) Based on the results of comparison, most efficient plan should be chosen

7) Possibility of confirmatory GCT trial is based on

① The result of prior exploratory studies

② PK profiles, effects of ethnic factors

12

China-Japan-Korea Tripartite Cooperation

1. Agreements on 31 October 2011 for Research of Ethnic Factors in Clinical PK Data

1) In order to assess ethnic difference in PK, a single protocol that controls extrinsic factors should be employed and uniformly applied to the study populations

2) Because polymorphisms of the relevant genes affect PK of a drug, it is recommended to know genotypes of study subjects and take them into consideration before evaluating the clinical data

3) Director Generals agreed to continue further research on ethnic factors from the view point of PK and PD analysis

13

China & Taiwan Regulatory Authority Interactions

1. 16 May 2013, simultaneous NDA filing across China & Taiwan• Filing of common core submission dossier by Taiwan based company TaiGen

Biotechnology in both China and Taiwan• First mutual data acceptance in Asia

2. Based on China and Taiwan signed “Cross Strait Medical and Health Care Cooperation Agreement” (Dec 21, 2010)

3. What does this mean in the regulatory setting?- Improved relations between China and Taiwan on the regulatory front with clear

implications for the pharmaceutical sector- The first case of an identical data package being submitted simultaneously to two

distinct regulatory regimes in Asia (CFDA in China and TFDA in Taiwan) - First product filed under the 2010 Cross Strait Agreement which allows the

mutual acceptance of clinical data, and the first drug from Taiwan to be accepted as Category 1.1 product in China

- Potential seen to support China filings with Taiwan clinical data

Source: Scrip Regulatory Affairs, 01 Jul 2013

14

ASEAN Economic Community (AEC)

1. ASEAN History• The Association of Southeast Asian Nations, or ASEAN, was established on 8

August 1967, comprising namely Indonesia, Malaysia, Philippines, Singapore and Thailand

• Brunei Darussalam joined on 7 January 1984

• Vietnam on 28 July 1995

• Lao PDR and Myanmar on 23 July 1997

• Cambodia on 30 April 1999

• Making up what is today the 10 Member States of ASEAN

• The total population of ASEAN in 2010 was 593 million

2. ASEAN Economic Community (AEC) : Goal of regional economic integrationby 2015

• A single market and production base

• Highly competitive economic region

• Region of equitable economic development

• Region fully integrated into the global economy

15

ASEAN Consultative Committee for Standards and Quality (ACCSQ)

• ACCSQ was formed in 1992 to facilitate and complement the ASEAN Free Trade Area (AFTA)

• ASEAN Pharmaceutical harmonization was agreed upon in 1999 and the Pharmaceutical Working Group (PPWG) was formed

• Main objective was to facilitate economic integration initiatives for pharmaceutical products without compromising their quality, safety and efficacy

16

Current Status: Pharmaceutical Harmonization

1. Scope and Strategies of PPWG include:

• Establish common technical documents to achieve mutual recognition agreements (MRA)

• Develop common technical requirements for pharmaceutical registration

• Develop and implement a common technical dossier

• Harmonization of clinical trials is not included

2. Status:• The 21st PPWG meeting will be held 17-20 June 2014 in Kuala Lumpur• The ACCSQ-PPWG has made progress, but faces challenges • ACTD implemented, with ongoing development of technical guidelines• Sectoral MRA on GMP signed 2009• Post-Market Alert system implemented, expanded to include counterfeit and

adulterated products• ASEAN Variation guidelines implemented (31st July 2013)• Terms of Reference (TOR) for Technical Working Group (TWG) for Biologics (2011)

17

Harmonization Issues & Challenges

• Country specific requirements still remain

• Different level of details in interpreting and implementing the guidelines

• Different pace in the revision, adoption and implementation of the guidelines

• Limited guidelines for biologic products

• Knowledge, resources, experience and capacity

Pan Asia Trial Regulatory StrategyBridging Data Package Requirements to support NDAVaccines Development

19

Pan Asia Trial Regulatory Strategy

1. ICH E5 Guideline : A multi-regional clinical trial (MRCT) for the purpose of bridging could be conducted in the context of a global development program designed for near simultaneous world-wide registration

2. A multi-regional study should be designed with sufficient numbers in order to have a reasonable likelihood of showing an affect in each region of interest

3. Step-by-step consideration is important

4. Investigating East Asian data may be key to confirming appropriate doses for Asian population and to establishing good foundation of global study including Asian regions

5. New initiative in place to promote MRCT in East Asia: regulatory collaboration among China/Korea/Japan to develop guideline to conduct MRCT in East Asia

20

Clinical Trial Landscape in Asia

No.Asia Pacific

Country NameNumber of

Studies1 Korea, Republic of 53442 China 49373 Australia 41714 Taiwan 35085 Japan 31866 India 24367 Thailand 15148 Singapore 12659 New Zealand 107510 Hong Kong 95011 Philippines 66212 Malaysia 65713 Pakistan 25414 Indonesia 24015 Vietnam 19016 Bangladesh 16817 Sri Lanka 33

30590Sub totalwww.clinicaltrials.gov(accessed 14 May 2014)

21

Multi-Regional Clinical Trial (MRCT) Landscape in A sia

1. Commonly practiced approach from past to present- Driven by US/EU regions including Asia on as needed basis during the course of

drug development- In such global setting, huge pressure on timeline to complete studies to support

NDAs in originating regions such as US/EU- Asia often as add-on region contributing into smaller portion of global package

that will eventually support US/EU, however, often failing to meet local requirements to support NDAs in designated Asian countries

- As a result, additional bridging PK/PD study conducted to meet local requirements in delaying drug approval process in Asia

2. Shifting direction for future approach- Proactively adhering to already existing ICH E5 Guideline to have MRCT for the

purpose of bridging could be conducted in the context of a global development program designed for near simultaneous world-wide registration including Asia

- A multi-regional study should be designed with sufficient numbers in order to have a reasonable likelihood of showing an affect in each region of interest

22

PK Study Requirements & Bridging Data Consultation

1. South Korea- No mandated PK study requirements - Phase III in Korean patients if not qualified for bridging waiver- Bridging data package based on global data can be submitted only

when no ethnic difference between Korean and other ethnic group has been proven through Korean data from global studies

2. Taiwan- Most flexible accepting other Asian data outside of Taiwan- Local PK study required if not qualified for bridging waiver- In addition to the PK study (particularly concerning ethnic factors),

global/regional clinical study reports and CPPs are also required for submission. If there are not at least 2 CPPs available globally, global/regional studies should include

1) Phase I (at least 10 local subjects) plus Phase III (at least 80 local patients), or 2) Phase II (at least 20 local patients) plus Phase III study (at least 80 local patients) results (which is conducted in Taiwan) would be required as per applicable regulations

23

PK Study Requirements & Bridging Data Consultation

1. Japan- Three major types of clinical development strategies in Japan

1) Single-country development2) Bridging development to which foreign data is extrapolated3) Global development including confirmatory global clinical trials

- Optimal protocol should be developed for the next phase based on the data available at the moment

2. China- If the study data aims to be used for future Chinese import registration

purposes, the study design needs to follow the requirements of an import registration study in China

- In principle, it should be a randomized, controlled, double blinded study design with 100 patients per arm + Phase I (bridging PK) study as well as meeting statistical significance for Chemical under Category 3

24

Vaccines Development

The development and marketing authorization of vaccines have always been challenging, but in recent years, the challenges have increased, influenced by three factors:

� The complexity of vaccines

� Globalized manufacturing chains

� Increasingly complex regulatory requirements

25

Vaccines are Complex Products

� Chemistry and Manufacturing

Antigen Antigen Production Platform Vaccine Type

Seasonal influenza - egg based

Fertilized Chicken Egg Sub-unit(surface antigen, inactivated)

Rabies virus Primary chicken fibroblast cell culture Inactivated purified virus

Tick-borne Encephalitis Virus Primary chicken fibroblast cell culture Inactivated purified virus

Japanese Encephalitis virus Vero cell culture Inactivated purified attenuated virus

Pentavalent pediatricD,T, wP, CRM-Hib, HBsAg

Bacterial Culture – D,T, wP, HibRecombinant (yeast) - HBsAg

Toxoid – D, TInactivated bacteria – wPGlycoconjugate - HibWell defined recombinant - HBsAg

Meningitis Type C Bacterial Culture Glycoconjugate

Meningitis Types ACWY Bacterial Culture Glycoconjugate

Seasonal Influenza – cell based

MDCK cell culture Sub-unit(surface antigen, inactivated)

Meningitis Type B E.Coli recombinant

Bacterial Culture – OMV (outer membrane vesicle)

Mixture of well defined recombinant proteins and OMV

26

Complexity Drives Time and Cost of Development

� Timely Understanding of Antigens, Product and Process is Critical

� Eggs� Mammalian Cell� Primary Culture� Bacterial� Yeast

Process

CombinationsAntigens:� Inactivated� Attenuated� Conjugates� Recombinant

Adjuvants

1. Dedicated Facilities

2. No dominant production platform

3. Constraints on process change

4. Limited transferability of skills/knowledge between products

5. High capital investment for Manufacturing Facilities

Product

Impact

27

Number of Recipients

Vaccines: are for millions of normal, healthy infants, adolescents and adults; treatment often mandated

Drugs: intended for treatment of subpopulations

Use of adjuvantVaccines: may contain an adjuvant that enhances immunogenicity. Adjuvants require separate preclinical safety programs and their use must be justified

Drugs: no adjuvant

Animal model

Vaccines: there may be no appropriate animal species, especially for therapeutic vaccines (e.g. anti-cancer, anti-allergy vaccines)

Drugs: Studies of a drug's toxicity include organs that are targeted by that drug, animal models often established

Doses

Vaccines: dose can be very small (e.g. 1 µg), no pharmacokinetics, efficacy is dependent upon immune responses

Drugs: classic studies on pharmacokinetics

How are prophylactic vaccines different from drugs? From a preclinical study perspective

28

Larger data basesVaccines: can be 10,000 to 60,000 subjects – often children

Drugs: typically a few thousand subjects

Longer follow-upVaccines: 6 to 12 months

Drugs: typically shorter (1-2 months)

Safety focus

Vaccines: solicited short term reactions and rare immune-mediated events

Drugs: focus on all non-solicited adverse events

Concomitant administration

Vaccines: immune responses and safety with routine vaccines in multiple schedules

Drugs: focus on concomitant drugs often taken by patients with a given disease

What are the main differences related to vaccine registration dossiers when comparing to drugs?

29

Rare, low incidence diseases

May rely on immune response surrogate endpoints

Example: meningococcal disease, hepatitis B disease

Pandemic influenza

Mock-up file (EU) that contains only manufacturing details, but which is built on a flu vaccine that is already approved

Example: H5N1 influenza vaccine

Special circumstances related to vaccine’s registra tion dossiers when comparing to drugs

30

HA Expertise

Vaccines: Strong expertise in US and EU health authorities. Weak elsewhere

Drugs: expertise more widespread

Review IssuesVaccines: 50% Clinical, 50% Manufacturing

Drugs: review issues are primarily clinical

Complexity

Vaccines: Analytical characterization is a challenge

Drugs: can be well characterized

Vaccines: Often need bridging clinical studies to introduce major manufacturing changes

Drugs: changes can be introduced by use of analytical comparability

Main differences on interactions with Health Author ities (HA) in vaccine registration dossiers, when compare d to drugs

31

Peculiarities of Clinical Vaccine Development

Healthy Subjects (often children) – instead of patients • Importance of pharmacovigilance• High numbers (> 60,000 and beyond)• Reluctance of some countries to participate in global studies

Short development times Seasonality High logistical complexity (cold chain of vaccines, shelf life)

Strong involvement of supranational and GO / NGO organisations WHO, Gates Foundation, GAVI, SAGE, and many others

Once approved: fundamentally different business Avid interest of the public Vocal opposition; e.g. in Germany and the UK

Recent Developments in APEC RHSC (Regulatory Harmonization Steering Committee)Risk/Benefit Assessment

33

Recent Developments in APEC RHSC

1. Asia-Pacific Economic Cooperation (APEC) created in 1989

2. 21 member economies account for 40% of world population, 54% of GDP and 44% of world trade

3. Australia, Canada, China, South Korea, Mexico, Russia, the United States, and Japan

4. Life Sciences Innovation Forum (LSIF), created following endorsement by APEC Leaders in 2002

5. Regulatory Harmonization Steering Committee (RHSC) Mandate: to promote a more strategic, effective and sustainable approach to harmonization

6. APEC Harmonization Center (AHC)

34

Future Focus & Outlook by APEC on Regulatory Convergence

• 12 May 2014, APEC group said its membership had committed to a "greater alignment of policies safeguarding pharmaceuticals, medical devices and biomedical goods“

• “There is considerable variation in medical product manufacturing, distribution, and import-export practice requirements, not to mention differences in the oversight of things like internet pharmacies which are proliferating,” said Ryan MacFarlane, co-chair of the APEC Life Sciences Innovation Forum

• APEC said its goal is to work toward a "regulatory convergence" of practices and standards by 2020

• APEC member nations are trying to balance international best practices along with the costs of compliance

• An update on the initiative will be published by APEC - August 2014

35

Roadmap to Promote MRCT – Step by Step Implementation

Training/ Workshop geared to reach the Goal- Recommendation for regulatory harmonization

(2017 – 2020)

Step 4Training/

Workshop

Interim Assessment of Achievement

(2016)

Step 3Evaluation

Training/ Workshop on Various Topics- ICH E5- Quality of Clinical Data- Training for researchers, exp. for regional diseases

(2013 – 2015)

Step 2 Training/

Workshop

Assessment of Status Quo- Scientific Issues- Logistics & administrative issues

(2010 – 2012)

Step 1 Assessment

36

Growing Demand to Make Meaningful Benefit-Risk Assessments in Asia

1. Companies must demonstrate the value of their products in meeting medical needs effectively, safely, and affordably, to address the growing demands of overall benefit/risk assessment and associated development rationale from the regulatory authorities in Asian countries

2. Need to invest in comparative effectiveness research and by designing trials to meet the needs of both regulators and payers in Asian countries

3. Particularly to effectively deal with less transparent regulatory body under continuously evolving regulatory climate as China’s CFDA, following key benefit areas to be focused over potential risks foreseen;

– Unmet medical needs– Innovative/advanced technology– Superiority over commercially available products from one of the following aspects:

• Efficacy• Safety• Cost• Environmental protection

37

Growing Demand to Make Meaningful Benefit-Risk Assessments in Asia

1. Challenges to get vaccines included on national immunization schedules

2. Vaccine-preventable diseases often occur at low incidence, especially in developed economies

3. Funding agencies such as GAVI and UNICEF help provide funding for vaccines in developing countries

4. With the prevalence of different infectious diseases, the need for vaccines in Asia can differ from those in the USA or Europe

5. Funding agencies want to see evidence of disease prevalence and cost-benefit assessments based on clinical studies/models in order to make decisions on funding of vaccines

38

22%

36%

48%

RUSSIA11

Represents serogroups not defined for each individual countryYW-

135B CA X

BRAZIL 3

18%

75%

COLOMBIA 4

CANADA 1

USA2

ARGENTINA5

48%43%

EUROPE6

71%13% TURKEY7

AFRICAN MENINGITIS

BELT9

18%

59%

SOUTH AFRICA10

42%

13%21%

SAUDIARABIA 8

JAPAN 12

TAIWAN13

50%35%

57%21%

AUSTRALIA 14NEW

ZEALAND 15

62%

25%

26%

40%

20%48%

30%

65%

32%78%

24%

43%

31%

23%

15%

22%

37%

Global Neisseria meningitidis Serogroup Distribution Is Varied and Dynamic, Making Trends Unpredictable

1. Dang V, et al. BMC Infect Dis. 2012;12:202; 2. Centers for Disease Control and Prevention. Active Bacterial Core Surveillance Report, Emerging Infections Program Network, Neisseria meningitidis, 2010. http://www.cdc.gov/abcs/reports-findings/survreports/mening10.pdf; 3. Ibarz-Pavón AB, et al. PLOS One. 2012;7:e44102; 4. Organización Panamericana de la Salud. Washington, DC: Organización Panamericana de la Salud, 2011; 5. INEI-ANLIS CG Malbrán 2009; 6. European Centre for Disease Prevention and Control. Surveillance of invasive bacterial diseases in Europe 2008/2009. Stockholm: ECDC; 2011; 7. Ceyhan M, et al. Presented at: 6th World Congress of the World Society for Pediatric Infectious Diseases; November 18-22, 2009; Buenos Aires, Argentina; 8. Al-Mazrou YY, et al. Saudi Med J. 2004;25:1410-1413; 9. Intercountry Support Team - West Africa Week 44-47, 2011. World Health Organization (WHO) website. Meningitis Weekly Bulletin. http://www.meningvax.org/files/BulletinMeningite2011_S44_47.pdf; 10. von Gottberg A. Comm Dis Surveill Bull. 2012;10:60-63. http://www.nicd.ac.za/assets/files/Communicable%20Diseases %20Surveillance%20Bulletin%20August%202012.pdf; 11. Gniel D, et al. Impf Dialog. 2008;8:13-22; 12. Takahashi H, et al. J Med Microbiol. 2004;53:657-662; 13. Chiou CS, et al. BMC Infect Dis. 2006;6:25; 14. Australian Meningococcal Surveillance Programme. Commun Dis Intell. 2011;35:217-228; 15. Lopez L, et al. The Epidemiology of Meningococcal Disease in New Zealand in 2010. Wellington, New Zealand: Institute of Environmental Science and Research Ltd (ESR); 2011.

MEN-BEX-M-M-814-212013

39

Incidence of Meningococcal Disease: Asia-PacificLimited surveillance data available due to incomplete reporting

Australia: 1.1 3

China: 2.86 6

India: 1.21*

Pakistan: 3.77*

Saudi Arabia: 0.02 7

New Zealand: 2.7 4

ASIA

AUSTRALIA

Japan: 0.01 5

Taiwan: 0.2 2

Cases per 100,000 persons

1. Anker M, et al. WHO Report on Global Surveillance of Epidemic-prone Infectious Diseases. World Health Organization (WHO) website. http://www.who.int/csr/resources/publications/surveillance/WHO_Report_Infectious_Diseases.pdf; 2. Chiou CS, et al. BMC Infect Dis. 2006;6:25; 3. Number of notifications of Meningococcal disease (invasive), Australia, 2012 by age group and sex. Department of Health and Ageing Notifiable Diseases Surveillance System website. http://www9.health.gov.au/cda/source/Rpt_4.cfm; 4. Lopez L, et al. The Epidemiology of Meningococcal Disease in New Zealand in 2010, 2011. Wellington, New Zealand; 5. Takahashi H, et al. J Med Microbiol. 2004;53:657-662; 6. Ni JD, et al. Postgrad Med J. 2008;84:87-92; 7. Saudi Arabia Health Statistical Year Book, 2009. Saudi Arabia Ministry of Health website. http://www.moh.gov.sa/en/Ministry/Statistics/book/flash/1430/MOH_Report_1430.html.

Levels of surveillance vary across countries, which may limit direct comparisons of disease incidence.*Incidence estimate based on cases reported to WHO (1983–1998).1

MEN-BEX-M-M-814-212013

40

Conclusion

• A decision to include Asia in global drug development should be made as early as possible, late addition can bring more challenges than opportunities

• Put aside the ‘perception’ that Asia region’s regulatory environment is complex different from global standards

• Maximize the use of current regulatory convergence efforts to align with global drug development strategies including Asia for both commercial and non-commercial reasons

41

Source

1. DIA’s first annual What Lies Ahead for 2013? Report

2. 2012 APEC Advanced Good Review Practices Workshop, Chinese Taipei, 6-8 November 2012

3. APEC Moving Toward ‘Regulatory Convergence’ in Effort to Safeguard Drugs, Improve, Manufacturing, 13 May 2014, Regulatory Focus

4. 9th DIA Annual Meeting November 19-21, 2012 | Tokyo, Japan

5. Consideration on mutual recognition of clinical trials: study on ethnic factors in China, Japan and Korea, ICDRA: Workshop H (25 October 2012)

6. Scrip Regulatory Affairs, 01 Jul 2013

7. Asia Regulatory Conference: Asia’s Role in Global Drug Development, April 26-28, 2011, Seoul, Republic of Korea

Like to know more?

Enquiries@iconplc.com

Twitter handle: @ICONplc

Join us on social: