Transcript 金融危机下的中国医药产业发展及药品注册管理法规体

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
Overview
1.
2.
3.
4.
5.
6.
Progress on the Laws and Regulations
concerning Drug Registration in 2009
Major Measures adopted on Drug Registration
in 2009
Statistics on China’s Pharmaceutical Industry in
2009
Approval on Drug Registration in 2009
International Exchanges on Drug Registration in
2009
Progress on Anti-Counterfeiting Drugs in 2009
Progress on Laws and Regulations
concerning Drug Registration
Laws and Regulations on Drug
Registration
Drug Administration
Drug Registration
Technical Guidelines on Drug Research
Laws and Regulations on
Drug Administration
laws
Laws and
Regulations on
drug
administration
Administrative regulations
SFDA decrees
Normative documents
Technical Guidelines on Drug Research
Laws and Regulations
on Drug Registration
Provisions on Drug
Registration
Special approval of drug
registration
regulations(2009)
Supplementary
Requirements on the
Registration of TCMs
Requirements
on
the
Registration of Technical
Transfer for Drugs （2009）
Requirements on the
On Site Inspection for
Drug Registration
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)
Laws and Regulations on
Drug Registration
The Provisions on Drug
Standards
Provisions on Drug Standards are
being drafted and will be
implemented in 2010.
Provisions on Drug Registration
15 Chapters and 177 Articles
Provisions on Drug Registration
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.
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)
Supplementary Documents for
the Newly Revised Provisions
on Drug Registration
 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
Requirements on Special
Review for Drug Registration
Foundation

Forty-fifth article of Provisions on Drug
Registration:
specific requirements on special review shall be
drafted independently
General Principles and Objectives
Early intervention, prioritized review, multichannel communication, and real-time information
updating
Strike a balance between promoting innovation
and controlling risks
Encourage and support the development of new
drugs
Major Content
1、Adopt multiple measures to promote innovation
2、Enhance risk control to better regulate
Adopt multiple measures to
promote innovation
1.
Independent channel and prioritized review
independent filing
independent coding
prioritized review
limited timeframe
Adopt multiple measures to
promote innovation
2.
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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.
Adopt multiple measures to
promote innovation
3.
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Timely intervention, and communication
mechanism on key stages
Early communication
time: before applying for clinical trials
content：application for special review, key
technical issues
Specialized communication
time：during technical review and during
clinical trials
content ：key security issues，clinical trial
plan，evaluation on phased clinical trials
Adopt multiple measures to
promote innovation
4.
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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
Enhance risk control to better
regulate
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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
Four Guidelines on Implementation
1.Guidelines on Materials on Independent Filing
of Products Subject to Special Review
2. Guidelines on Communication Mechanism for
Products Subject to Special Review
3. Guidelines on Meeting Minutes for Special
Review
4. Guidelines on Information Release concerning
Products Subject to Special Review
Progress of Implementation
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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.
Requirements on Registration of
Technical Transfer of Drugs
To Encourage
the Innovation
To Stimulate
the Market
To Promote the
Concentration and Saving
To Save
the Cost
To Open the
Transfer Market
To Regulate
the Registration
To Ensure
the Quality
To Control
the Risk
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.

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.
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.
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.
Technical
Review
Clinical Trial
Transferor
BE study
Other study
Batch production
Transferee
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.
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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.
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.
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.
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.
Technical Guidelines on
Drug Research
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.
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
Technical Guidelines on Drug
Research
Asking for Comments
Chemical Drugs: 4
TCMs: 1
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.
Major Measures adopted on
Drug Registration
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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.
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
To carry out the evaluation on the
implementation of GCP
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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.
To initiate the review process on drug
re-registration
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Every province has developed a work plan
for re-registration;
3028 products got re-registered throughout
China.
To stick to the science-based evaluation and
to strengthen the control of risks
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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.
To use all kinds of methods to ensure
transparency
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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”
Methods Introduced in 2009 to Ensure the
Openness and Transparency of the Technical
Review
Methods
1.Public Review
2.To publicize the
review cases
3.Openning Day
4.Consultation Day
Amount
When reviewing the
H1N1 vaccines, technical
review was organized in
a public way and the
votes were made on the
spot.
Methods
6.Video Conferences
To publicize almost 70 7.Seminars
cases and their analysis
on the website.
11 times, 281 people.
8.Consultation Meetings
(communication
meetings)
4000 people
9.Experts’ consultation
5. Information release Answer 1600 questions
Amount
10
14 seminars with
4000 participants.
80
11 consultation
related to 282 drugs.
To Initiate the Special Procedure
and to Ensure the Disease
Prevention and Control
In order to deal with emergencies, SFDA issued the
following documents:
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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
To Initiate the Special Procedure
and to Ensure the Disease
Prevention and Control
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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.
To Promote the IT System on Drug
Registration
The NDRC approved SFDA’s 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

Data Analysis on Statistics of Drug
Registration in 2009
Market Approval in 2009
Drug Registration Approval in 2009
Type of Concentrated
Medicines
Review
Chemicals
834
TCMs
1474
Biological
/
Products
Imported
Drugs
Total
Total
Regular Review
548
92
38
/
114
2308
792
3100
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
Approval for domestic production
Registration
Changed
Type
New Drugs Dosage Generics
Forms
Chemical
175
17
356
Drugs
72
8
12
TCMs
Biological
Products
Total
Total
38
678
Total
Approval for
Importation
548
100
92
1
38
13
114
792
Various Categories of Domestic New Drugs approved in 2009
Registration
Type
Chemical
Drugs
TCMs
Class
1
13
inc：
1.1, 2；
1.3, 2；
1.5, 6，
Original
Class I,
3
Class
2
20
inc：
2, 1
Original
class II, 19
Class
3
95
inc：
3.1,69；
3.2,18；
3.3,4；
3.4,2；
Original
Class III, 2
NOTE: Calculated according to
Number of Receiving and Acceptence.
Class
4
47
inc：
4, 14；
Original
Class IV,
33
Class
5
Class
6
/
/
2
70
Inc:
6, 65；
Original
Class VI,5
Ratio of the Compounds or TCM preparations and the
Number of Receiving and Acceptance
Approvals for Chemical Drugs
Changed
New
Dosage Generics
Drugs
Forms
Approvals for TCMs
Changed
New
Dosage
Generics
Drugs
Forms
Compounds or
Prescriptions
94
16
142
72
8
12
Number of
Receiving and
Acceptance
175
17
356
65
8
11
Ration
1:1.9
1:1.1
1:2.5
1:1.1
1:1
1:1
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 1:1.9, for the changed dosage forms, 1: 1.1, for generics, 1:2.5, much
lower than the ration in 2008 (1:2.5 for new drugs and 1:3 for generics). While for
the approval for TCMs, it shows that there is no repeated applications for TCMs.
Comparative Analysis on
Application Items
Rations of Different Application Items Calculated
according to the Numbers of Receiving and Acceptance.
Approvals for Chemical
Drugs
New
Drugs
Changed
Dosage
Forms
Number of
Receiving and
Acceptance
175
17
356
Proportions
32%
3%
65%
Approval for TCMs
Changed
Dosage
Forms
Generics
72
8
12
78%
9%
13%
New
Generics
Drugs
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
Statistics on Receiving and
Acceptance in Recent Five Years
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.
Testing on Imported Drugs
Number of Unqualified Batches
30
26
25
20
15
10
7
6
5
4
3
2
2
2
F X1 L
J
S X2 R1 R2 M
1
1
1
1
1
1
0
H1 Y
D
K H2
* Calculated according to the disqualified batches
Testing on Imported Drugs
Value of unqualified drugs（10,000 dollars）
500
450
400
350
300
250
200
150
100
50
0
F H1 X1 S Y M R1 D J K X2 L R2 H2
Data Analysis on Drug Registration
Approvals in 2009
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The numbers of applications returns
to normal;
The repeated applications were
reduced;
Rational application structure
reached and remained.
Statistics on Pharmaceutical
Industry in 2009
The Rapid Development of Chinese
Pharmaceutical Industry in spite of Depression
The total value of output of
pharmaceutical industry will
increase 26% in 2010on the basis
of 2009，profit will increase
30%
In 2009,total industrial output value of the
pharmaceutical industry exceeded 1,040
billion, which was 21.18% increase
comparing with last year.
1998～2009，the average annual
growth of the total value of output of
pharmaceutical industry in our
country was 20%，which was double
of the GDP growth.
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
Opportunities for the Development of
Chinese Pharmaceutical Industry
The rigid requirements of medical reform and public health create
opportunities
• Basic medical insurance system in 2011 and 850 billion input in 3 years
• Rigid requirements increase caused by accelerated aging and urbanization growth
• Pharmaceutical industry will have a new upward inflection point when GDP per capita
is more than 3,000 dollars.
R&D industry transfer and opportunities of concentrative drug
patents expiring
• Contractor for processing, custom contract research and development outsourcing
industry as the main form of transfer
• Increasing Opportunities of generic drugs along with the concentrative drug patents
expiring in 10 years
The international options of local pharmaceutical companies create
opportunities
• The international registration recognition of united states and EU countries
• Various forms of foreign layout, including mergers and acquisitions and IPO
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.
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.
Root causes of problems in pharmaceutical industry
have not been resolved
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Large number of small businesses and low
industrial concentration
Insufficient R&D 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
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%
Conclusion
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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.
International Exchanges in 2009
International Cooperation Programs related
to Drug Registration in 2009
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
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)
Progress on the AntiCounterfeiting Drugs in 2009
The effectiveness of the joint fight against
counterfeit medicines of china’s 13 ministries
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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 yuan;16,000 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
Joint Mechanism on Anti-Counterfeiting
Activities among 13 Ministries in China
Objective: to solve the difficult problem that one
Ministry of Information
single agency cannot deal with counterfeiting
Ministry of Public Security,
Industry:
alone.
to strengthen the
supervision

of cases by referring the
Jurisdiction Explanations
Combat on internet sale of
Counterfeiting Drugs
Combat on major and
serious criminal cases
To supervise the information
on the internet
Standardize the release
of pharmaceutical ads
SAIC:
to strengthen the
regulation on drug
advertisement
SFDA,
to make full use of
the joint mechanism
Develop combined effects,
strengthen supervision, ，
use associative
mechanism appropriately
Combat on distributing
counterfeiting drugs
through post system
State Post Office:
To strengthen the
regulation on mailbox
rent and posted drugs
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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.
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
Documents Issued by
Members of the Joint Mechanism
Ministry of Industry and Information
Technology
Ministry of Health
Food and Drug Administration
•Notice of the Specific Rectification Campaigns on the services of national internet
health care and medicine information
•Notice of establishing the management system of domestic illegal internet blacklist
Ministry of Public Security
Food and Drug Administration
•Combined to publish “the interpretation of specific law application to handle with
criminal cases of production , sale of counterfeiting drugs and drugs of inferior
quality” on the “two high” to train public security organs and drug sector—to
establish closer handling relationships and improve the investigation quality of
counterfeit
Ministry of Commerce
Food and Drug Administration
•“Strengthening the administration of the pharmaceutical distribution industry”
required commercial departments at all levels actively cooperated with relevant
departments to make the drug safety rectification work of drug circulation well
Ministry of Commerce associated with Food
and Drug Administration、
Ministry of foreign affairs、General
Administration of Customs、Administration
of Quality Supervision, Inspection and
Quarantine
•“The report on the export of non-drug” was submitted to the State Council , “study on
the establishment of drug export management system” was the focus to be
undertaken
Thank you very much!