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Title: Establishment and Implementation of Regulations and Policies on Drug Registration and Impacts on the Pharmaceutical Industry of China

1
Establishment and Implementation of Regulations
and Policies on Drug Registration and Impacts on
the Pharmaceutical Industry of China

ZHANG WEI
Director General, Department of Drug Registration
May 17, 2010, Beijing
2nd DIA China Annual Meeting

2
Overview

Progress on the Laws and Regulations concerning
Drug Registration in 2009
Major Measures adopted on Drug Registration in
2009
Statistics on Chinas Pharmaceutical Industry in
2009
Approval on Drug Registration in 2009
International Exchanges on Drug Registration in
2009
Progress on Anti-Counterfeiting Drugs in 2009

3
Progress on Laws and Regulations concerning Drug
Registration
4
Laws and Regulations on Drug Registration

?Drug Administration
?Drug Registration
?Technical Guidelines on Drug Research

5
Laws and Regulations on Drug Administration
laws
Laws and Regulations on drug administration
Administrative regulations
SFDA decrees
Normative documents
Technical Guidelines on Drug Research
6
Laws and Regulationson Drug Registration
7
Laws and Regulations on Drug Registration

Other Normative Documents
?Guidelines on Protection over TCM Products
(2009)
?Requirements on Biological Products
?Requirements on File Management of APIs and
Excipients (will be implemented in 2010)
?Provisions on Hospital Preparations (Interim)

8
Laws and Regulations on Drug Registration
Provisions on Drug Standards are being drafted
and will be implemented in 2010.
9
Provisions on Drug Registration15 Chapters and
177 Articles
10
Four Versions ? Provisions on New Drug Approval,
implemented on May 1, 1999 ? Provisions on Drug
Registration (interim), implemented on December
1, 2002 ? Provisions on Drug Registration,
implemented on May 1, 2005 ? Provisions on Drug
Registration, implemented on October 1, 2007.
Provisions on Drug Registration
11
Supplementary Documents for the Newly Revised
Provisions on Drug Registration

Supplementary Requirements on Registration of
TCMs (22 Articles)
Requirements on On-Site Inspection for Drug
Registration (6 chapters and 55 articles)
Requirements on Special Review and Approval for
Drug Registration (22 Articles)
Requirements on Registration of Technical
Transfer of Drugs (4 chapters and 26 articles)

12
? Improve laws and regulations on drug
registration? Provide details related to core
content of Provisions on Drug Registration?
Enhance practicability of the Provisions ?
Combine supervision and service
Supplementary Documents for the Newly Revised
Provisions on Drug Registration
13
Requirements on Special Review for Drug
Registration
14
Foundation

Forty-fifth article of Provisions on Drug
Registration
specific requirements on special review shall
be drafted independently

15
General Principles and Objectives

Early intervention, prioritized review,
multi-channel communication, and real-time
information updating
Strike a balance between promoting innovation
and controlling risks
Encourage and support the development of new drugs

16
Major Content

1?Adopt multiple measures to promote innovation
2?Enhance risk control to better regulate

17
Adopt multiple measures to promote innovation

Independent channel and prioritized review
independent filing
independent coding
prioritized review
limited timeframe

18
Adopt multiple measures to promote innovation

Convenient, scientific and reasonable access
mechanism
If consistent with items 1 and 2 of the 45th
article, start the procedures when submitting
clinical application, and confirm within 5
working days
If consistent with items 3 and 4 of the 45th
article, start the procedures when submitting
production application, and organize expert
review in 20 days
If included in special review when submitting
clinical application, include directly in the
procedures when submitting production application.

19
Adopt multiple measures to promote innovation

Timely intervention, and communication mechanism
on key stages
Early communication
time before applying for clinical trials
contentapplication for special review,
key technical issues
Specialized communication
timeduring technical review and during
clinical trials
content key security issues,clinical
trial plan,evaluation on phased clinical trials

20
Adopt multiple measures to promote innovation

Timely gather supplementary materials through
multiple channels
On review conferences participated by applicants
and experts
After meetings proposed by applicants
For key security issues
According to notices on supplementary information
Allow changes in clinical services to improve
efficiency
Timeframe increased from 4 months (for common
application) to 8 months

21
Enhance risk control to better regulate

Make risk control plan when submitting
application, and allow market entry upon meeting
certain conditions.
Set up an exit mechanism for application for new
drug registration special review
Establish a database for application for new drug
registration special review to facilitate public
supervision

22
Four Guidelines on Implementation1.Guidelines on
Materials on Independent Filing of Products
Subject to Special Review2. Guidelines on
Communication Mechanism for Products Subject to
Special Review3. Guidelines on Meeting Minutes
for Special Review4. Guidelines on Information
Release concerning Products Subject to Special
Review
23
Progress of Implementation

Twenty-eight products have entered special review
procedures, including 23 chemical drugs and 5
biological products.
Twenty-seven products are for APIs, finished
products or biological products that have never
been marketed in China or any foreign countries.
(Article 2.2) One is for a new drug that has
therapeutic advantages or there is no effective
treatment for the diseases. (article 2.3)
Other 11 products which are evaluated according
to the Requirements on Special Review and
Approval are for drugs or vaccines for the
treatment and prevention of H1N1.

24
Requirements on Registration of Technical
Transfer of Drugs
25
P0licy Points
26
Requirements on Registration of Technical
Transfer of Drugs Key Point 1

To Encourage the Innovation
to encourage the combination of research and
production, to promote the commercialization of
research projects, to promote the introduction of
foreign new technology and to show the strong
commitment on the innovation.

27
Requirements on Registration of Technical
Transfer of Drugs Key Point 2

To Promote the Concentration and Saving
to encourage the good companies to carry
out asset restructuring, to rationally allocate
the resources, to adjust the product structure,
to update the technologic capacity and to make
full use of the advantages, so as to promote the
concentration of the entire industry.

28
Requirements on Registration of Technical
Transfer of Drugs Key Point 3

To Open the Transfer Market
on the basis of new drug technical transfer,
to enlarge the scope of transfer and allow the
technical transfer for new drug prior to the
expiry of monitoring period as well as the
transfer of manufacturing technology after the
expiry of monitoring period.

29
Requirements on Registration of Technical
Transfer of Drugs Key Point 4

To regulate the Registration
to regulate the registration process between
the two sides of the technical transfer by
setting up criteria on the qualification,
technical standards and requirements. In the
past, there was no need to carry out technical
review and clinical validation before the
technical transfer of the new drug , now things
have been changed and the technical threshold
has been improved.

30
Requirements on Registration of Technical
Transfer of Drugs Key Point 5

To control the Risks
to control the safety risks by three
methods, including dynamic control, static
control and procedure control.
Static Control high risk products are not
applicable for technical transfer
Dynamic Control Where high risks are newly
discovered, the technical transfer shall be
ceased.
Procedure Control where safety risks are
discovered during the process of technical
review, the technical transfer shall not be
approved.

31
Requirements on Registration of Technical
Transfer of Drugs Key Point 6

To Ensure the Quality
with the strict technical review and the
validation research carried out by the
enterprises, the quality of the products before
and after the transfer shall be consistent.

Safety, Efficacy, and Quality Control
32
Requirements on Registration of Technical
Transfer of Drugs Key Point 7

To Save the Cost
The companies are able to gain the license by
technical transfer, not by changing dosage forms
or applying for generic drugs. By these means,
the cost on research and development as well as
timing could be saved, the low-level redundant
production can also be reduced. The one-one
transfer may also enable us to control the total
number of drug approval licenses.

33
Requirements on Registration of Technical
Transfer of Drugs Key Point 8

To Stimulate the Market
The enterprises can restructure their assets
by implementing technical transfer. The market of
pharmaceutical technology could be promoted and
the merger and cooperation could also be
encouraged.

34
Technical Guidelines on Drug Research
35
Technical Guidelines on Drug Research

? To regulate the drug research activities and to
promote the level of drug research
? The introduction of ICH guidelines
? To deal with the global drug research and to
promote the mutual recognition on drug
registration as well as the standard
harmonization
? To improve the requirements on drug safety by
considering the new problems discovered during
the daily regulation.

36
Technical Guidelines on Drug Research

? Formally promulgated 80
? chemical drugs 31 (the Technical Guidelines on
Drug Carcinogenicity Study will be issued soon.)
? TCMs 12
? Biological Products 26
? General Subjects 6
? General Principles 5

37
Technical Guidelines on Drug Research

?Asking for Comments
?Chemical Drugs 4
?TCMs 1

38
Technical Guidelines on Drug Research

?Cases
taking the problems detected by regulation into
consideration, SFDA issued some technical
requirements and guidelines into consideration
since 2008 in order to improve the requirements
on drug safety.
? Basic Technical Requirements on Injections
? Basic Technical Requirements on Multi-Compound
Bio-Chemical Injections
? Technical Guidelines on the Research on Changes
of Marketed Chemical Drugs
? Technical Guidelines on the Research on Changes
of Marketed TCMs.

39
Major Measures adopted on Drug Registration
40

To regulate the on-site inspection for drug
registration
To carry out the evaluation on the implementation
of GCP
To initiate the review process on drug
re-registration
To stick to the science-based evaluation and to
strengthen the control of risks
To use all kinds of methods to ensure
transparency
To rationally allocate the resources and to
improve the efficiency of technical review.

41
To regulate on-site inspection for drug
registration

In order to unify the standards and
procedures, the provincial Food and Drug
Administrations have developed the following
documents for the on-site inspection for drug
registration
implementation guidelines and working procedures
SOPs and other requirements for inspectors
In 31 provinces of China, we have carried out
3721 on-site inspections for drug registration,
among them, 1133 are for new drug applications,
1198 are for generic drug applications and 1390
are for the application on changes.

42
To carry out the evaluation on the implementation
of GCP

To carry out the re-check on GCP clinical
research institutes
To carry out on-site inspection on the clinical
trials of imported drugs and to evaluate the
implementation of GCP.

43
To initiate the review process on drug
re-registration

Every province has developed a work plan for
re-registration
3028 products got re-registered throughout China.

44
To stick to the science-based evaluation and to
strengthen the control of risks

To carry out the research on the CTD of generic
chemical drugs
To develop and implement the Technical Guidelines
on Drug Carcinogenicity Study
To adopt the third party validation in order to
ensure a reliable and scientific review result
To hold the specific seminars and consultations
in order to solve the common problems during the
technical review, to unify the review standards
and to ensure the consistency of the review
result.

45
To use all kinds of methods to ensure transparency

To make almost 70 review cases public
To have communication with the applicants by
expert consultation, consultation meeting, video
conference, teleconference, etc.
When reviewing the H1N1 vaccines, technical
review was organized in a public way. The
principles of public votes and public involvement
were introduced in order to ensure the safety and
efficacy of vaccines as well as the transparent
and opened evaluation.
To use different methods such as consultation
day, opening day, mailbox of the director general
in order to strengthen the communication with the
society, to promote the openness and transparency
of technical review and to establish a sunshine
review gradually.

46
Methods Introduced in 2009 to Ensure the Openness
and Transparency of the Technical Review
Methods Amount Methods Amount
1.Public Review When reviewing the H1N1 vaccines, technical review was organized in a public way and the votes were made on the spot. 6.Video Conferences 10
2.To publicize the review cases To publicize almost 70 cases and their analysis on the website. 7.Seminars 14 seminars with 4000 participants.
3.Openning Day 11 times, 281 people. 8.Consultation Meetings (communication meetings) 80
4.Consultation Day 4000 people 9.Experts consultation 11 consultation related to 282 drugs.
5. Information release Answer 1600 questions
47
To Initiate the Special Procedure and to Ensure
the Disease Prevention and Control

In order to deal with emergencies, SFDA
issued the following documents
Notice on the Preparation of H1N1 Vaccine
Production
Work Plan on the Special Review and Approval for
H1N1 Vaccines
Work Plan on the Review and Approval of H1N1
Vaccines
Key Items on the Research and Development of H1N1
Vaccines
Notice on Strengthening the Regulation on
Research and Development of H1N1 Vaccines
Notice on the On-Site Inspection for the H1N1
Vaccine Samples for Clinical Trials.
Notice on Issuing the Approval License for H1N1
Vaccines

48
To Initiate the Special Procedure and to Ensure
the Disease Prevention and Control

To approve 10 H1N1 vaccines for marketing
To approve the importation of Zanamavir Powders
To approve the enlarged production and changed
manufacturing process of Phosphate Oseltamivir.

49
To Promote the IT System on Drug Registration

The NDRC approved SFDAs proposal on Phase I IT
System on Drug Regulation on September 30, 2009.
The Department of Drug Registration established
the IT system on the Insert Sheet and Labeling of
Drugs and initiated the testing program on that
system.
IT systems to be established in 2010
IT system on the Filing of APIs and Excipients.
IT system on the Drug Standards Management

50
Data Analysis on Statistics of Drug Registration
in 2009
51
Market Approval in 2009
Drug Registration Approval in 2009
Type of Medicines Concentrated Review Regular Review
Chemicals 834 548
TCMs 1474 92
Biological Products / 38
Imported Drugs / 114
Total 2308 792
Total 3100 3100
52
The Drug Approvals Made in Accordance with the
Newly Revised Provisions on Drug Registration
The Drug Approvals made in accordance with the
newly revised Provisions on Drug Registration in
2009
Registration Type Approval for domestic production Approval for domestic production Approval for domestic production Approval for domestic production Approval for Importation
Registration Type New Drugs Changed Dosage Forms Generics Total Approval for Importation
Chemical Drugs 175 17 356 548 100
TCMs 72 8 12 92 1
Biological Products 38 38 38 38 13
Total 678 678 678 678 114
Total 792 792 792 792 792
53
Various Categories of Domestic New Drugs approved
in 2009
Registration Type Class 1 Class 2 Class 3 Class 4 Class 5 Class 6
Chemical Drugs 13 inc 1.1, 2 1.3, 2 1.5, 6, Original Class I, 3 20 inc 2, 1 Original class II, 19 95 inc 3.1,69 3.2,18 3.3,4 3.4,2 Original Class III, 2 47 inc 4, 14 Original Class IV, 33 / /
TCMs 2 70 Inc 6, 65 Original Class VI,5
NOTE Calculated according to Number of Receiving
and Acceptence.
54
Ratio of the Compounds or TCM preparations and
the Number of Receiving and Acceptance
Approvals for Chemical Drugs Approvals for Chemical Drugs Approvals for Chemical Drugs Approvals for TCMs Approvals for TCMs Approvals for TCMs
New Drugs Changed Dosage Forms Generics New Drugs Changed Dosage Forms Generics
Compounds or Prescriptions 94 16 142 72 8 12
Number of Receiving and Acceptance 175 17 356 65 8 11
Ration 11.9 11.1 12.5 11.1 11 11
This ration can show the status of repeated
application. The statistics show that the ration
of chemical compounds for new drugs and the
number of receiving and acceptance is 11.9, for
the changed dosage forms, 1 1.1, for generics,
12.5, much lower than the ration in 2008 (12.5
for new drugs and 13 for generics). While for
the approval for TCMs, it shows that there is no
repeated applications for TCMs.
55
Comparative Analysis on Application Items
Rations of Different Application Items Calculated
according to the Numbers of Receiving and
Acceptance.
Approvals for Chemical Drugs Approvals for Chemical Drugs Approvals for Chemical Drugs Approval for TCMs Approval for TCMs Approval for TCMs
New Drugs Changed Dosage Forms Generics New Drugs Changed Dosage Forms Generics
Number of Receiving and Acceptance 175 17 356 72 8 12
Proportions 32 3 65 78 9 13
The Ration of New Drugs reflects the status of
drug research, review structure and tendency. The
annual statistics (calculated according to the
number of receiving and acceptance) shows that
the new chemical drugs accounts for 32 of the
total approval, while for changed dosage forms,
3, for generics, 65. For TCMs, the proportion
is 78, 9 and 13(see the form above). While for
the year 2006 and 2007, the ration of new drug is
no higher than 15 and the changed dosage forms
and generics accounts for more than 80.)
56
Statistics on Receiving and Acceptance in Recent
Five Years
57
Testing on the Imported Drugs
Imported Drug Testing in 2009
Categories Total Batches Tested Imported Batches Total Sum Imported(Billion US dollars) Disqualified Batches
Chemical Drugs 21451 21400 80.4 51
TCMs 2410 2393 2.4 17
Biologics 1375 1375 13.5 0
Total 25236 25168 96.4 68
In 2009, 25236 batches (9.64 US dollars) imported
drugs were tested and 25168 batches were
qualified and 68 batches were disqualified.
58
Testing on Imported Drugs
Calculated according to the disqualified batches
59
Testing on Imported Drugs
60
Data Analysis on Drug Registration Approvals in
2009

The numbers of applications returns to normal
The repeated applications were reduced
Rational application structure reached and
remained.

61
Statistics on Pharmaceutical Industry in 2009
62
The Rapid Development of Chinese Pharmaceutical
Industry in spite of Depression
63
The Increase of Chinese Pharmaceutical Industry
in 2009
CategoryM Output(100 million RMB) Increase Ratio()
APIs 1837.5 13.7
Finished Chemical Drugs 2758.6 19.0
TCMs 1998.0 24.0
Processed Slices 511.7 28.3
Bio-chemicals 887.2 29.1
Medical Equipments and Devices 950.0 22.9
Hygiene Materials and Medicinal Products 520.7 29.0
Total 9915.9 21.4
64
Opportunities for the Development of Chinese
Pharmaceutical Industry
65
Policy Factors that may Affect the Pharmaceutical
Industry in 2010

In 2009, there are many policies related to
medicines were promulgated.
In April, 2009, the new plan on medical reform
was issued
In May, the Comments on the Promotion of TCM
Industry was issued
In June, the Comments on the Promotion of
Biologic Products Industry was issued
The List of Essential Medicines and the List on
Medical Insurance.
These policies have greatly stimulated the
demand for medicines and the industry tended to
move towards the local and village level. The
concentration of the industry was encouraged and
the market became larger and larger.

66
Anticipation of the Future Chinese Pharmaceutical
Industry
In 2011, China will become the third biggest
market for pharmaceuticals in the World.

From 2009 to 2013, it is estimated that
17countries will boast the increase of total sale
of medicines, which accounts for 90 billion US
dollars and accounts for 48 of the total
increase throughout the world. While in 2009, the
proportion is 37.
The great changes on the world economy, the
development of health industry (improvement of
medical service and increased investment), and
the changed proportion between generics and
innovative drugs have led to the adjustment of
the market.

67
Root causes of problems in pharmaceutical
industry have not been resolved

Large number of small businesses and low
industrial concentration
Insufficient RD investment, low innovation
ability, low proportion of high-tech products
Gap between international and domestic quality
control systems and practices
Drug quality and safety incidents
Lack of fair and orderly market to ensure
survival of the best
low competitiveness of low value-added exported
products

68
Outstanding problems in pharmaceutical industry

The extensive growth mode
high input, high consumption, high
pollution, high emissions, low efficiency, low
concentration and low technological level
Export volume of 2009 was 19.2 billion USD,
of which 16.6 billion was raw materials,
accounting for 86.24 medicine, 1.2 billion and
biological durgs, 1.45 billion.
1299 companies which produce western
medicines exported their products, including 181
foreign-fuded enterprises, accounting for 14.
However the proportion of exports accounted for
51.92

69
Conclusion

In spite of the background of financial crisis,
the pharmaceutical industry in China has
increased and the increasing rate is higher than
the common ratio of the other industry sectors.
In 2009, the strengthened legal system of drug
registration as well as other important
activities had greatly promoted the healthy
development of Chinese pharmaceutical Industry.

70
International Exchanges in 2009
71
International Cooperation Programs related to
Drug Registration in 2009

Meeting with Senior Delegation of PHAMA and
BIO(April, 2009, Changsha)
Training on GCP Inspection with RDPAC/FDA (June
11 to 14, 2009, Beijing)
Training on GLP Inspection with RDPAC/FDA
(Sept.10 to 13, 2009, Hangzhou)
Meeting with Mr. Kasoff, Deputy Assistant
Minister of US DOC, (Sept. 2009, Beijing)
JCCT Seminar on Data Protection (Sept. 2009,
Beijing)
JCCT Seminar on Anti-Counterfeiting Drugs (Nov.
2009, Beijing)
Seminar on Generic Biologic Products with BIO
(Nov.5, 2009, Beijing)
The First DIA China Conference, (Nov. 1 to 3,
2009)
Sino-Korea-Japan Seminars on Clinical Trials
(Dec.17, 2009, Beijing)
The First Meeting of China ICH Research Group,
(Dec.2009, Beijing)
The Second Meeting of China ICH Research Group,
(April, 2010, Beijing)
International Seminar on Marketing Licenses with
RDPAC (March, 2010, Beijing)
Seminar on the Clinical Trial Supervision of
Biologic Products with BIO (March 24, 2010,
Beijing)

72
Progress on the Anti-Counterfeiting Drugs in 2009
73
The effectiveness of the joint fight against
counterfeit medicines of chinas 13 ministries

Joint conference system for inter-ministerial
coordination to combat sales of counterfeit drugs
was set up in April
Three joint committee, one coordinators meeting,
and a national television and telephone
conference were held
546 illicit networks were closed(MITT)
323 registered cases, of which 320 were
solved(Ministry of Public Security)
A number of major and serious criminal cases of
more than 10 million were uncovered
More than 6000 pieces of illegal medical
advertisements were investigated, fined 40
million yuan16,000 cases of illegal advertisers
were investigated, a fine of more than 60
million. Ordered to stop publishing more than
20,000 unlawful sex drugs ad(Trade and industry
Bureau)
30 people in broadcast organizations have been
dealt with (Radio Division)
606 times administrative compulsory measures to
suspend false medical advertisements on illegal
sales, revocation of 44 pharmacy license number,
recovery or write-off of 12 health food approval
number. Three internet consumers in the safety
alert bulletin and one illegal drugs, medical
devices notice were released, 75 illegal
businesses were exposed

74
Joint Mechanism on Anti-Counterfeiting Activities
among 13 Ministries in China

Objective to solve the difficult problem that
one single agency cannot deal with counterfeiting
alone.

Ministry of Information Industry To supervise
the information on the internet
Ministry of Public Security, to strengthen the
supervision of cases by referring the
Jurisdiction Explanations
SFDA, to make full use of the joint mechanism
SAIC to strengthen the regulation on drug
advertisement
State Post Office To strengthen the regulation
on mailbox rent and posted drugs
75

The Working Procedure on Joint Mechanism the
Joint Conference on Combat on Counterfeiting
Drugs and the Functions of the Members of Joint
Conference on Combat on Counterfeiting Drugs.
For the combat on counterfeiting drugs
distributed through internet or post system
Notice of the Specific Rectification Campaigns on
Fraudulent Advertisement or Distribution through
Post System and the Implementation Plan.