01(2 3)HN Exploring China Symposium 20143.ppt...Commercial Medical Insurance China Healthcare...
Transcript of 01(2 3)HN Exploring China Symposium 20143.ppt...Commercial Medical Insurance China Healthcare...
Helen Niu Product Development In Selected Asian Countries
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China’s Role In Biomedical Industry: Past, Present, and Future
November 1st, 2014USC International Regulatory Science Symposium
Helen Niu, MD, PhDBeijing, China
Agenda
The World Story
The China Story
China Healthcare System
China Pharmaceutical Industry
Historical perspective on Globalization of Drug Development
China Pharmaceutical Regulations
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The World Story
The China Story
Source: China NBS figures:figures of 1952-2008: Originated from China Statistical Yearbook 2013
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The China Story (cont.)
Source: China NBS figures:figures of 1952-2008: Originated from China Statistical Yearbook 2012,http://www.usgovernmentspending.com/us_gdp_history; McKinsey Quarterly July2011; www.economywatch.com
The Transformation of Chinese Society
Sources: K Eggleston, Stanford University, Asia Health Policy Program working paper, January 9, 2012, http://asiahealthpolicy.stanford.edu; http://data.worldbank.org/indicator/SP.DYN.TFRT.IN?page=6
Early 1950’s 2010
Population 0.5 Billion, 36% less than 15ys,
80% rural
1.34 Billion, 16.6% less than 15ys,
50.3% rural
Literate Rate 70% 96%
Life Expectancy
@40 yrs 72.5 yrs for Man76.8 yrs for Women
Economy System
a closed, centrally planned system
more market-oriented; plays a major global role
FertilityRate
@6 1.7
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China Healthcare System -Health Insurance
Sources: K Eggleston, Stanford University, Asia Health Policy Program working paper, January 9, 2012, http://asiahealthpolicy.stanford.edu
Prior to China Economic Reform (50s-70s)Wide spread basic coverage: the rural population had access to basic health services under cooperative medical schemes (CMS) managed by agricultural communes.The urban population was largely covered by work unit based health insurance either through the Labor Insurance System or the Government Insurance System.
Between 1980 and 2000The majority of China’s population did not have health insurance: the implementation of user fees as public funding declined in urban setting; and the dissolution of rural cooperatives and association of cooperative medical schemes (CMS).
China Healthcare System-Health Insurance (cont.)
Sources: K Eggleston, Stanford University, Asia Health Policy Program working paper, January 9, 2012, http://asiahealthpolicy.stanford.edu
Basic Medical Insurance:In 1996, the Central Government experimented with the re‐establishment of cooperative medical schemes (CMS) in rural areas. The Government announced direct budgetary support for the Rural CMS (RCMS) in 2002. By 2009, 94% of rural counties offered RCMS.
In urban areas, the Urban Employees’ Basic Medical Insurance system (UEBMI) Was established in 1998. By the end of 2006, UEBMI covered 64% of the Urban employed population (31% of the total urban population). In 2007, the government launched and rolled out the Urban Residents’ Basic Medical Insurance program (URBMI) nationwide, which covers urban residents not enrolled in the employee insurance program, including students, retirees, and other dependents.
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Basic Medical Insurance:
NCMS
UEBMI
URBMI
Supplementary Medical Insurance:
Civil Servant Subsidies
Supplementary Company Insurance
Target group Insurance
Commercial Medical Insurance
China Healthcare System-Health Insurance (cont.)
Sources: K Eggleston, Stanford University, Asia Health Policy Program working paper, January 9, 2012, http://asiahealthpolicy.stanford.edu
China Healthcare System-Government Stakeholders
Sources: K Eggleston, Stanford University, Asia Health Policy Program working paper, January 9, 2012, http://asiahealthpolicy.stanford.edu
Stakeholder Function and ResponsibilityNDRC (nationaldevelopment & reform commission
Monitoring and evaluating healthcare system reform; setting the price for drugs and medical services
Ministry of Finance Financial support and investment in healthcare; subsides for health care insurance
Ministry of Health Operations of RCMS; public hospital reform
Ministry of Human Resources & Social Security
Management of UEBMI and URBMI
Ministry of Civil Affaires
Poverty alleviation; medical aid for the poor
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China Healthcare System-Public Hospital System
Public hospital accreditation began in 1989.
In 2011, China had 1,350 public tertiary hospitals, 6034 secondary hospitals and 2908 Primary hospitals
Source: “The classification and management of the hospitals” MOH China November 29, 1989; http://www.sda.gov.cn
Class I (Primary) Class II (Secondary) Class III (Tertiary)
Hospital bed # 20-99 100-499 Over 500
Departments Minimal clinical departments: ER, Internal Medicine, Surgery Dept, OB/GYN, and Preventive Medicine
More specialty departments More specialty departments
Resource >0.7 Healthcare professional/bed >0.4 nurse /bed>0.88 Healthcare professional/bed
>0.4 nurse /bed>1.03 Healthcare professional/bed
Approval party City government health department
Provincial, Municipalgovernment
Provincial, Municipalgovernment
MOH for Special class 3
China Pharmaceutical Market
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China Pharmaceutical Market – Major Changes in Recent Years
Source: Healthcare in China Entering uncharted waters. McKinsey&Company July 2012
2006 2011
Total HC Expenditure $156 bn $357 bn
Per capita healthcare expenditure $119 $261
Population with health insurance 43% 95%
Market▪ Size▪ Global ranking
▪ $27 bn▪ Number 9
▪ $71 bn▪ Number 3
Combined revenues of top 10 pharmaceuticalmultinationals
$4 bn $10 bn
Number of sales reps from top -10 multinationals
6,000 25,000
Traditional Chinese Medicine, market size
$6 bn $13 bn
Vaccines, market size ~$1.2 bn ~$2 bn
Market▪ Size▪ Global ranking
▪ $8 bn▪ Number 6
▪ $20 bn▪ Number 3
Pharmaceuticals
Others
Medical Device
Overall
China's Macro-Economy -Significant Structural Changes
2005 2010 2015 Trend through 2015
10% 11% 7~8%GDP growth moderates potentially with volatility
~26% ~17% ~10%Export sees slow growth but structural upgrade
38% 37% 40%Consumption rapidly expands & outgrows GDP
41% 43% 45%Service rapidly expands & outgrows GDP
44% 47% 52%1 Inland accounts for more than half of China GDP
2% 21% 50%MAC pop. increases drastically
$1.1 $2.2 $4.6Labor cost keeps increasing rapidly
8.2 6.8 5.7RMB keeps appreciation at ~3% a year
Real GDP growth
Five-year avg export growth
Consumption GDP share
Service GDP share
Inland GDP share
Middle-class & affluent pop.2
Hourly labor wage
USD : RMB
1. Based on the preliminary GDP growth target for 12th FYP already announced by 23 out of 31 provinces or municipalities directly under administration of Central Government2. Annual household income > $10,000 Source: EIU, National Bureau of Statistics, State Information Center, analyst reports, literal research, BCG analysis
Consumer expansion
Wealth redistribution
Environ. protection
Quality urbanization
R&D and high tech upgrade
Equitable society (corruption & compliance)
Policy levers Implications
• Reassess the underlying drivers and build scenarios for the pharma market growth
• Ride the wave of consumer expansion
• More demand for upgraded products and services
• Rising operational cost promoting commercial model redesign using new tech and different cost structure
• Learn from and prepare for rising local competition with more innovation
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Key Consumer Trends - the Future of the China Market
1.Middle and Affluent Class ("MAC"), defined as households with annual disposable incomes of at least 72,000 Rmb (in constant 2010 prices)Source: BCG Analysis
Behavior: Evolving mind of Chinese consumers
Size: Changes of income and geography
Shape: Shifting Chinese demographics
Power of brand and trading Up
• Trading up and brand power continue to resonate with consumers
Urbanization• By 2020, ~270 cities as
wealthy as Shanghai in 2010 level
Health and wellness• Health and wellness
become the #1 reason to trade up
Growing small cities• Mid-tier cities will see
the most significant MAC population growth
Rise of middle and affluent class1 (MACs)
• MACs will be ~50% of urban population (450Mn) in 2020 vs. 21% in 2010
Digital generation• China is already the
largest digital nation with 560 million on-line population, and largest e-commerce volume
Aging population• China one of the fastest
aging countries in the world, expected to have ~16% of population aged 60+ in 2020
New births• ~16-18M new born
babies annually from 2005 to 2015
Female economy• Women control 50% of
household spending in China—and are earning more than ever
The magnitude of footprint expansion required continues to grow
Product and service offerings for the senior, the young and the female
Product and service offerings for prevention; Digital channel to reach
and educate patients
Historical perspective on Globalization of Drug Development
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Before 1975:
FDA accepted non-US clinical studies as supportive only.
In 1978:
Dr. J. Richard Crout stated that it was the credibility of data, not their country of origin, which should be the determining factor in the use of these data as primary evidence for drug approval.
1981:
Timolol for prevention of myocardial re-infarction based on Norwegian data was the first approval of a new indication for a marketed drug based on foreign data alone.
FDA History of Acceptance of Foreign Clinical Data
Khin Maung, DIA 40th meeting Washington DC 2004
CFR on Acceptance of Foreign Data
CFR Title 21
Part 312: Investigational New Drug Application21 CFR 312.120: Foreign clinical studies not conducted under an IND
Part 314: Applications for FDA Approval to Market a New Drug
21 CFR 314.106: Foreign Data (marketing approval based solely on foreign data)
[52 FR 883, Mar. 19, 1987, as amended at 52 FR 23031, Jun. 17, 1987; 56 FR 22113, May 14, 1991; 64 FR 401, Jan. 5, 1999; 67 FR 9586, Mar. 4, 2002]
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ICH Founder Members
EMEA European Medicines Agency
EFPIA European Federation of Pharmaceutical
Industries and Associations
FDA US Food and Drug Administration
PhRMA Pharmaceutical Research and
Manufacturers of America
JMHLW Japan Ministry of Health, Labour
and Welfare, Japan
JPMA Japan Pharmaceutical Manufacturers
Association
ICH E5 - Acceptance of Foreign Data
The ICH guideline E5: Ethnic Factors in the Acceptability of Foreign Clinical Data was endorsed by ICH Feb 98, and issued by FDA June 1998
In general, if the data developed in one region satisfy the requirement for evidence in a new region, but there is a concern about possible intrinsic or extrinsic ethnic differences between the two regions, then it should be possible to extrapolate the data to the new region with a single bridging study. The bridging study could be a pharmacodynamic study or a full clinical trial or possible a dose-response study.
http://www.fda.gov/cber/gdlns/iche5ethnic.htm#ii
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The Globalization of Drug Development
Trends in the globalization of clinical trials Fabio A. Thiers, Anthony J. Sinskey & Ernst R. BerndtNature Reviews Drug Discovery 7, 13-14 (January 2008)
The Globalization of Drug Development
Industry-sponsored clinical research of investigational drugs has traditionally been carried out in relatively developed countries in the North American, Western European, and Pacific regions.
Significant growth of activity in so-called emerging economies in Eastern Europe, Latin America, and Southeast Asia.
13% Global phase IIb-III sites are from the emerging area (23% average annual growth rate); North America stable; Western Europe experienced average -8% growth rate
Trends in the globalization of clinical trials Fabio A. Thiers, Anthony J. Sinskey & Ernst R. BerndtNature Reviews Drug Discovery 7, 13-14 (January 2008)
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Industry Sponsored Trials & MNC R&D Center in China
Industry Sponsored Trials
Source: wwww.clinicaltrial.gov; RDPAC Survey Report 2012
Phase 1 (96)Phase 2 (146)Phase 3 (514)
China Pharmaceutical Regulations
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Practical Steps in MAB Production
CFDA History
In 1998, the Ministry of Health's Department of Drug Administration merged with the State Pharmaceutical Administration of China to become the State Drug Administration (SDA).
The State Food and Drug Administration was founded on the basis of the State Drug Administration in 2003, and modeled after the US FDA.
In March 2013, CFDA has been elevated to ministry level which was announced during 18th National People’s Congress
Source: China Pharmaceutical Regulation Report 2006, Pacific Bridge Medical; Elsevier Business Intelligence , March 18, 2013
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GCP-Legal Status in China
Cao Cai, SFDA, DIA 41th Annual meeting, Washington D.C
Before 1998 Recommended for implementation
1998-Aug 1999 Trial period for GCP as rules
Sept 1999- Feb 2001
Implemented as rules
After Feb 2001 Upgraded to national law
Since Dec 2001 Mandatory implementation as National law
Chinese GCP Characteristics
No clinical trial can be conducted prior to official approval by CFDA
Applicant shall select a lawfully certified institution to conduct clinical trials and submit report for record
All clinical trial institutions subject to qualification by CFDA
Investigational products manufactured under GMP
Protection of trial subjects & written informed consent required
Cao Cai, SFDA, DIA 41th Annual meeting, Washington D.C
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The clinical trial of the medical device shall be conducted within qualified clinical trial institutes according to the requirements of the Good Clinical Practice (GCP) for medical devices.
Requirements for qualified hospitals are under review by MOH.
Notification to SH FDA before initiation.
Testing report will be valid for 1 year to support local clinical trial since issuing date.
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GCP (draft) Requirement for Device Trials
China Hospital System& SFDA Certified CTB (Clinical Trial Base)
Source: “The classification and management of the hospitals” MOH China November 29, 1989; http://www.sda.gov.cn
Class I Class II Class III
Hospital bed # 20-99 100-499 Over 500
Departments Minimal clinical departments: ER, Internal Medicine, Surgery Dept, OB/GYN, and Preventive Medicine
More specialty departments More specialty departments
Resource >0.7 Healthcare professional/bed >0.4 nurse /bed>0.88 Healthcare professional/bed
>0.4 nurse /bed>1.03 Healthcare professional/bed
Approval party City government health department
Provincial, Municipalgovernment
Provincial, Municipalgovernment
MOH for Special class 3
SFDA Certified CTBs
Number of Hospitals
Number of Dermatology Departments
Number of Ophthalmology Departments
Number of Plastic Surgery Departments
462 118(9 Traditional Medicine)
68 (7 Traditional Medicine)
6 (3 specialized on Burn)
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General Drug Registration Process
Clinical Trial Application
• CDE review
• CFDA approval
NDA•CDE review
• CFDA approval Ph IPh IIPh III
•New CTA needed
IND Stage
Clinical Trail
NDA Stage
Two submissions, two review processes with two approvals
LaunchLaunch
Type of Regulatory Applications
New drug application
(CTA & NDA)
For Chemical products: Cat. 1-4
For Biologics : Cat. 1-12
Generic drug application
(ANDA)
For Chemical products: Cat. 5-6 (Generally BE study is needed)
For Biologics : Cat. 13-15 (Ph3 clinical trial is needed)
Import drug application
(IMCT/Domestic CTA+NDA)
For drugs manufactured out of China: Cat 1& 3 for chemicals, Cat 1 & 7 for biologics
Supplementary application Variations
Renewal The approved certificate valid time is 5 years.
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Import Drug Registration Flow Chart –Both CTA & NDA
Application approval by CFDA
*
Chemicals IMCT: Sample testing is not applicable for IMCT. NDA needs QC testing with 3 batches.
Chemical domestic CTA : 3 batches DP per strength are required.
Biologics IMCT: 1 batch DP/strength
Biologics domestic CTA: 3 batches DP/strength; analysis method validation; 3 batches drug substance
Panel meeting will be held for critical issues
Yes.Review clock stops
Review will not be closed until testing report transferred to CDE
CDE technical review
Additional data requested?
CFDA Reception center
China Regulatory Applicant
Sample testing* by NIFDC
CDE technical review conclusion sent to CFDA
No
China Regulatory Agent
Application submissionwith paper documents
Paper receipt
Dossier and e-task transfer
Additional data supplement to CDE
directly
Registration Categories– for Chemical Drugs
Category 2 Category 6
Category 5Category 3
Drugs
Category 4
Category 1
Cat 1: Product never marketed in any country
Cat 2: Administration route Change and never marketed in any country
Cat 3: Drug marketed outside of China
Cat 4: Change API acid and alkaline
Cat 5: Change dosage form without changing administrationroute
Cat 6: Me-too/Following National Standard
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Minimum Sample Size for Chemical Drug
Category 1Cases
Category 2Cases
Category 3Cases
Category 4Cases
Category 5Cases
Category 6Cases
Phase I 20-30 20-30 PK PK PK NA
Phase II 100 100 NA NA NA NA
Phase III
300Per treatment
arm& Meet
Statistical requirement
300Per treatment
arm& Meet
Statistical requirement
100 pairs 100 pairs 100 pairs*100 pairs
for injection only
Phase IV 2000 2000 NA NA NA NA
BE NA NA NA NA 18-24** 18-24***
* For sustained release products, single, repeat PK and 100 pairs trial required ** For oral solid products, if BE can’t be conducted, then 100 pairs’ CT is requested*** BE not require for injection or non-oral solid products, but replaced by CT
Requirement for Clinical Trial(Chemical Drugs)Category Phase Minimum Sample Size
1 & 2(approved neither outside nor in China)
Randomized & Controlled Single Arm
I / 20-30
II 100 pairs /
III 300 ( test group)
IV / > 2000
3 & 4(approved outside China)
PK 10-12
Phase III
100 pairs( 60 pairs for additional indication)
/
5 & 6 (formulation change or generics)
BE or Phase III BE 18-24 or Phase III 100 pairs
The sample size should meet both the statistical requirement and the minimum sample size requirement by drug registration regulation.
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Global/Regional trialCategory 1: Biological product never marketed anywhere worldwide
Category 2: Monoclonal antibody
Category 3: Gene therapy, somatic cell therapy as well as the preparations
Category 4: Allergen products
Category 5: Multi component products with bioactivity extracted from, or by fermentation from
human and/or animal tissues and /or body fluid
Category 6: New combination product made from the already marketed biological products
Category 7: Biological product that approved overseas but not approved in China
Category 8: Some for the strains used for preparing of micro-ecological projects not yet approved
Category 9: Products with not completely same structure with the already marketed products and not yet marketed at domestic or overseas
Category 10: Products with a method of preparation different with the already marketed one
Category 11: Products first time made with DNA recombination technology
Category 12: Products transformed from non-injection into injection, or topical use into systemic
use, and not yet marketed at domestic or oversees
Category 13: The marketed products with a change in dosage form but no change in route of administration
Category 14: Products with a change in route of administration (excluding the above Cat 12)
Category 15: Biological product already approved in China
Local trial
Registration Categories – for Biologic Drugs
Minimum Sample Size for Biologic Product
Category 1-12 Cases
Category 13-15Cases
Phase I 20-30 NA/ PK*
Phase II 100 NA
Phase III300
Per treatment armMeet statistical requirement
300Per treatment arm
Phase IV 2000 NA
* For sustained release products, PK data are required .
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Requirement for Clinical Trial(Biological Product)
The sample size should meet both the statistical requirement and the minimum sample size requirement by drug registration regulation.
Category Phase Minimum Sample size
1 – 12*
(new product)
Category 7: biologics only approved outside China
Randomized &
Controlled
Single Arm
I / 20-30
II ≥100(test group)
III ≥300(test group)
IV / >2000
13 -15 (
formulation/administration change or
biosimilars)
Phase III ≥300(test group)
International Multi-center Clinical Trial (IMCT)
An international multi-center clinical trial (IMCT) is established in 2002 to facilitate China join international trial without a CPP
An IMCT CTA for a Ph3 can be filed after global Ph2 is initiated
At least three countries participate in IMCT
Clinical data requirement in IMCT meet Category 3/7 requirements (100 pairs for chemicals and 300 on test arm for biologics)
File an NDA under Category 3/7: CN NDA approval will be based on PK data in CN + IMCT data
Importation drug registration in China• Local CTA/NDA pathway with CPP• IMCT CTA/NDA pathway
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IMCT To NDA Process Update
-Established in 2002
- Facilitate China joining international trial without a CPP
- Precondition is the global Ph II is initiated
- At least three countries participate IMCT
2 submissions/2 approvals to 3 submissions to 3 approvals process
- Additional local CTA submission to obtain a waiver on local trial
- Time delayed to NDA over 2-3 years
Regulatory Background
Process Revision
Implication
- Still encourage simultaneous global development (SGD)- To draft a detailed technical guidelines of IMCT- But change IMCT definition as “Multi-Regional Clinical Trials”- Aim to promote local company to participate in the global SGD.
CFDA Next Step Plan
IMCT To NDA Process Update- Cont.
2 sub/2 Approval
3 sub/3 Approval
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DRR Amendment update- Draft version
Keyregulatorychanges Implication
• Amendmentsystem‐ Currentnoamendmentsystem,datainCTAareallfinal‐ AllowCMCchangestobesubmittedfornewdrugCTA
• Supportearlyphasedrugdevelopment
• Encourageinnovativedrugdevelopmentespeciallyearlyphase,e.g.phaseIandII,FIM
• Adjustdomesticsiteinspectionaftertechnicalreviewwithpositiveconclusion‐ CurrentdomesticinspectionwillbeinitiatedimmediatelyaftertheCTAsubmission‐ AvoidwastingCFDAresourcesandtimeifnegativereviewconclusion
• Fitdrugdevelopmentprocess• Encouragedomesticnewdrugdevelopment
• Linkagebetweendrugregistrationandpatentprotection‐ Currentanapplicationcanonlybe
submitted2‐yrbeforepatentexpiration.‐ Thegenericdrug’sapplicationcouldbe
submittedatanytime,butonlycanbeonmarketaftertheoriginalpatentexpiration
• Encouragedomesticfirsttogenericdrugs’development
Expedite clinical development for new imported drugs:•Currently 2 pathway of imported drug : local CTA with CPP or IMCT (3 sub/3 approval)•Internal discussion in CFDA to allow new imported drug to initiate a local trial •New drug: has never been approved in any country •This pathway ever available before 2009(mainly for ph III)•Re-discussion in Q3 2014
Key Changes
Implication
Provision of Standardizing Drug’s Applications - Draft version
• Encourage simultaneous global development for new drugs;
• Can file a local CTA without a CPP
- No clear criteria available
- No definition on CT phases
- Global data requirement unknown
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China CFDA (SFDA) Meeting
45Source: http://www.cde.org.cn/newspic.do?method=view&id=312809
46
CFDA (SFDA) – Technical Review
Source: http://www.sda.gov.cn/WS01/CL0001/
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47
CFDA (SFDA) – Technical Review
Source: http://www.sda.gov.cn/WS01/CL0001/
48
CFDA (SFDA) – Technical Review
Source: http://www.sda.gov.cn/WS01/CL0001/
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CFDA (SFDA) Application Submission Volume 2009-2012
Chemical TCM Biologics
Source: http://www.cde.org.cn/newspic.do?method=view&id=312809
2012 (CFDA) SFDA Submission Approvals
2012 NDA Approvals
2012 CTA Approval Class
Source: http://www.cde.org.cn/newspic.do?method=view&id=312809
Class
TCM
Biologics
Total
Chemical
Class
Class
TCM
Biologics
Total
NCENew
Formulation
Generic Imported Sub -T
Clinical Trial
Class Bioequivalence Sub - T
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Review Timeline by RDPAC Survey
31 out of 38 member companies participated timeline survey for 2011
510 drug applications were added / updated for 2011 survey
This report reflects all milestones achieved in 2011
Chemical drug and Biological product are covered
Import Drug License (IDL)
Multi-regional Clinical Trial (MRCT)
Import Drug License renewal (IDL renewal)
Source: RDPAC report 2011
51
15
59
39
62
17
0
10
20
30
40
50
60
70
IDL-CTA IDL-NDA MRCT IDL-Renewal
Chemical Therepeutic Biological Vaccine
# of submissions in 2011 (Total 150)
3439 39 37
49
57
1420 21
15
34
17
26
5155
64
87
76
0
20
40
60
80
100
2006 2007 2008 2009 2010 2011
# of CTA Filing # of NDA Filing # of MRCT Filing
# of submissions in 2006-2011
Source: RDPAC report 2011
numbernumber
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2417
35 38
66
23
5 8
2314
20
913
23
42
56
99
78
0
20
40
60
80
100
2006 2007 2008 2009 2010 2011
# of CTA Approval # of NDA Approval # of MRCT Approval
# of approvals in 2006--2011
22
7
63
39
0
10
20
30
40
50
60
70
IDL-CTA IDL-NDA MRCT IDL-Renewal
Chemical Therepeutic Biological Vaccine
# of approvals in 2011 (Total 110)
Source: RDPAC report 2011
numbernumber
IDL- CTA and IDL- NDA of Therapeutic Biological Products Approval time
Year 2009 2010 2011
IDL-CTA 16.1M(N=1) 17.8 M (N=15) 11.9M (N=1)
IDL-NDA N=0 18.6 M (N=1) 19.9M(N=2)
Source: RDPAC report 2011
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12.113.6
17.515.7
17.6
21.5
0
5
10
15
20
25
2006 2007 2008 2009 2010 2011
IDL-CTA (category 3.1)
N=16 N=18
IDL- CTA and IDL- NDA of Chemical Product approval Time
11.5
15.1
18.217.2
18
21.4
0
5
10
15
20
25
2006 2007 2008 2009 2010 2011
IDL-NDA (category 3.1)
N=5
N=23 N=34 N=35 N=14 N=17N=5 N=8N=17N=6
Source: RDPAC report 2011
Mon
th(i
n m
edia
)
7.1
9.310
9.4 99.8
0
2
4
6
8
10
12
2006 2007 2008 2009 2010 2011
Chemical Product (Category 1.1)
Timeline from date of submission to date of approval for IMCT of Chemical Product approved in 2006-2011
N=9 N=14 N=43N=29 N=28 N=37
Source: RDPAC report 2011
Mon
th(i
n m
edia
)
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China Pharmaceutical Market –More Changes to come
Source: Healthcare in China Entering uncharted waters. McKinsey&Company July 2012
2006 2011
Total HC Expenditure $156 bn $357 bn
Per capita healthcare expenditure $119 $261
Population with health insurance 43% 95%
Market▪ Size▪ Global ranking
▪ $27 bn▪ Number 9
▪ $71 bn▪ Number 3
Combined revenues of top 10 pharmaceuticalmultinationals
$4 bn $10 bn
Number of sales reps from top -10 multinationals
6,000 25,000
Traditional Chinese Medicine, market size
$6 bn $13 bn
Vaccines, market size ~$12 bn ~$2 bn
Market▪ Size▪ Global ranking
▪ $8 bn▪ Number 6
▪ $20 bn▪ Number 3
Pharmaceutical
s
Others
Medical Device
Overall
$1 trillion in 2020
Question?