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

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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
  1. Progress on the Laws and Regulations concerning
    Drug Registration in 2009
  2. Major Measures adopted on Drug Registration in
    2009
  3. Statistics on Chinas Pharmaceutical Industry in
    2009
  4. Approval on Drug Registration in 2009
  5. International Exchanges on Drug Registration in
    2009
  6. 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
  1. Supplementary Requirements on Registration of
    TCMs (22 Articles)
  2. Requirements on On-Site Inspection for Drug
    Registration (6 chapters and 55 articles)
  3. Requirements on Special Review and Approval for
    Drug Registration (22 Articles)
  4. 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.

76
  • Big Cases (over 10 million RMB)
  • Li Bin Case on April 14
  • BOZHOU Case on July 19
  • SUINING Case (counterfeiting drugs through post
    system)
  • YANTAI Case
  • HUZHOU Changxing Website Case
  • GUANGZHOU Case
  • YANCHENG Case on Internet Sale of Counterfeiting
    Drugs

77
Documents Issued by Members of the Joint
Mechanism
78
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