-
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Provisions for Drug Registration
(SFDA Order No. 28)
Provisions for Drug Registration
Chapter I
General Provisions
Article 1 The Provisions are formulated
for the purposes of ensuring the safety, efficacy
and quality of drugs and
regulating
drug registration in accordance with the Drug
Administration Law of the People's Republic of
China
(hereinafter referred to as the
Drug Administration Law), Administrative
Permission Law of the People's Republic
of China (hereinafter referred to as
Administrative Permission Law) and the Regulations
for Implementation of the
Drug
Administration
Law
of
the
People's
Republic
of
China
(hereinafter
referred
to
as
the
Regulations
for
Implementation of the Drug
Administration Law).
Article 2 The
Provisions apply to the applications for drug
clinical trial, drug production or import, and
conducting
drug
approval,
relevant
testing
for
drug
registration,
or
regulation
thereof,
within
the
territory
of
the
People's
Republic of China.
Article
3
Drug
registration
refers
to
the
process
of
review
and
approval
on
which
the
State
Food
and
Drug
Administration, in accordance with the
official procedures, evaluates the safety,
efficacy and quality of the drugs
applied for marketing, and decides
whether or not to approve such an application.
Article
4
The
State
encourages
the
research
and
development
of
new
drugs
and
adopts
the
special
review
and
approval with respect to
innovative drugs, new drugs for serious and life-
threatening diseases and to address unmet
medical needs and drugs.
Article 5 The State Food and Drug
Administration is in charge of drug registration
nationwide, and responsible for
reviewing and approving the clinical
trial, production and importation of drugs.
Article 6 The drug registration shall
follow the principles of openness, fairness and
justice.
The State Food and Drug
Administration adopts the system of collective
responsibility of the chief reviewers, the
system
of
publicizing
and
challenging
relevant
persons,
and
the
system
of
responsibility
tracing,
with
social
supervision in such procedures as
acceptance, inspection, review and approval and
sending.
Article
7
In
the
process
of
drug
registration,
the
drug
regulatory
department
shall
make
known
to
the
general
public, and hold hearings on, the
matters which it deems of vital importance and
involving public interests for the
granting of permission.
Prior to making the decision of
administrative licensing that has a direct bearing
on the vital interest between the
applicant and the other party, the drug
regulatory department shall inform the applicant
and the interested party of
their
rights of requesting for hearings, making
statements and argues.
Article 8 The
drug regulatory department shall provide the
applicant with access to information on the status
of the
acceptance, examination,
inspection, review and approval of drug
registration application and the final resolution.
The drug regulatory department shall
publicize the following information on its
official websites or at the official
premises for accepting applications:
(1) the items, procedures, fees and
their basis, and timelines of the drug
registration, index of all the data needed to
be submitted and model text of the
application form;
(2) the name list and
other relevant information on the persons involved
in the acceptance, examination, inspection,
review and approval of drug
registration; and
(3) general
information about categories of approved drugs,
etc.
Article 9 The drug regulatory
department, relevant institutions and persons
involved in the drug registration have
an obligation to keep the technical
secrets and trial data submitted by the applicant
confidential.
Chapter II
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Application for Drug Registration
Article
10
An
applicant
for
drug
registration
(hereinafter
referred
to
as
applicant)
refers
to
the
institution
that
submits a drug registration application
and assumes corresponding legal liability.
A domestic applicant shall be an
institution legally registered within the
territory of People's Republic of China
that independently assumes civil
liability and an overseas applicant shall be a
legal overseas drug manufacturer.
Where
an overseas applicant applies for import drug
registration, it shall be done by its branch or
entrusted agency
within the territory
of People's Republic of China.
The
persons who handle the application for drug
registration shall have professional knowledge and
be familiar
with the laws and
regulations on, and the technical requirements
for, drug registration.
Article 11 Drug
registration applications include applications for
new drugs, generic drugs, import drugs and their
supplementary applications as well as
re-registration applications.
Applications of domestic applicants
shall be handled according to the procedures and
requirements for new drugs
or generic
drugs, whereas applications of overseas applicants
shall be handled according to those for import
drugs.
Article 12 Application for new
drugs refers to application for registration of
drugs that have not been marketed
within the territory of People's
Republic of China.
Application for changing dosage form or
route of administration, or claiming a new
indication for marketed drugs,
shall be
submitted as the process of new drug application.
Application
for
generic
drugs
refers
to
registration
application
for
producing
the
drugs
having
existing
national
drug
standard
which
is
approved
to
be
marketed
by
the
State
Food
and
Drug
Administration,
whereas
the
application for
biological products shall be submitted as the
process of new drug application.
Application
for
import
drugs
refers
to
registration
application
for
drugs
manufactured
abroad
to
be
marketed
within the territory of the People's
Republic of China.
Supplementary
application
refers
to
application
for
variation,
addition,
or
cancellation
of
the
items
or
contents
approved in the
original application for new drug, generic drug or
import drug.
Re-registration
application
refers
to
application
for
continued
production
or
importation
of
a
drug
after
the
expiration of the valid term of the
drug approval document.
Article 13 The
applicant shall provide sufficient and reliable
research data to prove the safety, efficacy and
quality
of the drug, and be liable for
the authenticity of all the dossiers submitted.
Article
14
The
cited
literature
of
the
dossier
of
drug
registration
shall
indicate
the
title
of
works
or
the
name,
volume number, issue and page of the
journal. Where the cited references are not
published, an author's permission
shall
be provided. For foreign literatures, Chinese
translation shall be provided as required.
Article
15
The
State
Food
and
Drug
Administration
shall
obey
the
development
plan
and
policies
on
the
pharmaceutical industry
constituted by the State, and may conduct
assessment to the market value of drugs.
Article 16 In the process of drug
registration, the drug regulatory department shall
conduct on-site inspection and
causal
inspection
to
the
non-clinical
studies
and
clinical
trials,
as
well
as
production
site
inspection
for
the
pre-
marketing approval to confirm the authenticity,
precision and integrity of the dossier submitted.
Article 17 Where two or more
institutions jointly apply for drugs, the
application shall be submitted to the drug
regulatory department of the province,
autonomous region, or municipality directly under
the Central Government,
in which the
drug manufacturer is located; where the applicants
are all drug manufacturers, the application shall
be
submitted to the drug regulatory
department of the province, autonomous region, or
municipality directly under the
Central
Government,
in
which
the
manufacturer
of
pharmaceutical
preparations
is
located;
where
none
of
the
applicants
is
a
drug
manufacturer,
the
application
shall
be
submitted
to
the
drug
regulatory
department
of
the
province, autonomous region, or
municipality directly under the Central
Government, in which the site for pilot
production of drug samples is located.
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Article 18 An applicant shall provide
the information on patent and its ownership of the
applicant or other parties
in
China,
in
respect
of
the
drug
applied
for
registration,
its
formula,
manufacturing
processes
and/or
uses,
etc.
Where
another party owns the patent in China, the
applicant shall provide a statement of non-
infringement. The
drug regulatory
department shall publish the information or the
statement submitted by the applicant on its
official
website.
Where a
patent dispute occurs in the process of drug
registration, it shall be settled in accordance
with relevant
laws and regulations on
patent.
Article
19
For
a
drug
patented
in
China,
applicants
other
than
the
patentee
may
submit
the
application
for
registration two years prior to the
expiry date of the patent. The State Food and Drug
Administration shall review
the drug
application in accordance with the Provisions, and
after the expiry date of the patent, check and
issue the
drug approval number, Import
Drug License or a Pharmaceutical Product License
if the application conforms with
the
provisions.
Article
20
In
accordance
with
the
provisions
in
Article
35
of
the
Regulations
for
Implementation
of
the
Drug
Administration
Law,
where
a
manufacturer
or
distributor
submits
undisclosed drug
experimental
and other data
which are independently acquired in
order to obtain approval for production or
marketing of the drug in question
which
contains any new chemical entity, the State Food
and Drug Administration shall, within six years
from the
approval date of the drug,
reject any application made by any other
applicants by using the undisclosed data of the
drug in question without permission of
the original applicant who has obtained the drug
approval, unless the data
submitted are
independently acquired by the applicants other
than the original one.
Article
21
Pre-clinical
drug
study
for
drug
registration
application
includes
drug
synthetic
processes,
extraction
methods,
physical
and
chemical
properties,
purity,
selection
of
dosage
form,
screening
of
formula,
preparing
processes,
testing
methods,
quality
specifications,
stability,
pharmacology,
toxicology
and
animal
pharmacokinetics,
etc.
For
traditional
Chinese
medicine
preparations,
in
addition
to
the
above-mentioned
items,
pre-clinical
drug
study
also
includes
the
study
in
the
source
of
the
crude
drugs,
and
of
their
pre-
treatment
and
processing,
etc.
For
biological
products,
it
also
includes
study
on
the
source,
quality
specifications,
storage
conditions,
biological
characteristics
and
genetic
stability
of
the
starting
materials
such
as
bacterial
and
viral
seeds/strains, cell
lines, bio-tissues, and immunological study, etc.
Article
22
A
pre-clinical
drug
study
shall
be
in
conformity
with
relevant
requirements,
among
which
the
Good
Laboratory Practice for Non-Clinical
Laboratory Studies shall be implemented in the
study of safety evaluation.
Article
23
The
drug
research
institution
shall
have
relevant
staff,
premises,
equipment,
instruments
and
management system, which are
appropriate to the research project, and ensure
the authenticity of all experimental
data. Experimental animals, reagents
and raw materials used in the study shall conform
with the provisions of the
State.
Article 24 An applicant who entrusts
other institutions with a drug research,
individual experiment, testing, or pilot
production, etc. shall conclude a
contract with the trustee, and state it clearly in
the registration application. The
applicant shall be responsible for the
authenticity of the research data in the
application dossier.
Article 25 Where
the application is only for registration of
pharmaceutical preparations, any drug substance
used
for the study shall have a drug
approval number, an Import Drug License or a
Pharmaceutical Product License, and
be
acquired through legitimated means. Where a drug
substance used for the study has no drug approval
number,
Import Drug License or
Pharmaceutical Product License, the use of drug
substance in study shall be approved by
the State Food and Drug Administration.
Article
26
The
research
data
in
application
dossier
for
drug
registration
provided
by
an
overseas
drug
research
institution shall be attached with the
items and pages of the information, and with
notarized documents proving
that the
said drug research institution is legally
registered overseas. The State Food and Drug
Administration may
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send staff to conduct on-site
inspection in needs of drug review.
Article 27 The drug regulatory
department may request the applicant or the drug
research institution responsible
for
testing to repeat the test based on the items,
methods and data specified in the application
documents, and may
also
authorize
a
drug
testing
institute
or
another
drug
research
institution
to
repeat
the
test
or
conduct
methodological verification.
Article
28
The
drug
study
shall
be
conducted
according
to
the
relevant
technical
guidelines issued
by
the
State
Food
and Drug Administration. Where an applicant
conducts the study by adopting other evaluation
methods and
techniques, supporting data
proving the scientific feasibility of such methods
and techniques shall be provided.
Article 29 An applicant who obtains the
drug approval number shall manufacture according
to the manufacturing
processes approved
by the State Food and Drug Administration.
The
drug
regulatory
department
shall
supervise
and
inspect
the
applicant's
manufacture
in
accordance
with
the
approved
manufacturing processes and quality
specifications.
Chapter III
Drug Clinical Trials
Article
30 Any drug clinical trial, including
bioequivalence study, shall be approved by the
State Food and Drug
Administration, and
shall be in compliance with the Good Clinical
Practice.
Drug regulatory department
shall supervise and inspect the approved clinical
trials.
Article 31 Clinical trials
shall be conducted for new drug registration
applications. As for generic drug registration
applications and supplementary
applications, clinical trials shall be conducted
in accordance with the requirements
in
the Annex of the Provisions.
A clinical
trial consists of phases I, II, III and IV.
Phase
I
Clinical
Trial:
initial
clinical
pharmacology
and
safety
evaluation
studies
in
humans.
These
studies
are
designed to observe tolerability of
humans to and pharmacokinetics of a new drug, in
order to provide basis for
establishing
the administration regimen.
Phase
II
Clinical
Trial:
preliminary
evaluation
of
therapeutic
effectiveness
of
a
drug.
The
purposes
are
to
preliminarily evaluate
the therapeutic effectiveness and safety of the
drug for particular indication(s) in patients,
and
provide
evidence
for
design
of
Phase
III
clinical
trial
and
settlement
of
administrative
dose
regimen.
According
to
specific
trial
objectives,
this
phase
of
trial
may
be
designed
in
various
forms,
including
the
randomized blind controlled clinical
trial.
Phase III Clinical Trial:
confirmation of therapeutic effectiveness of a
drug. The purposes are to further verify drug
therapeutic effectiveness and safety on
eligible patients with target indication(s), to
evaluate overall benefit-risk
relationships
of
the
drug,
and
to
ultimately
provide
sufficient
evidence
for
the
review
of
drug
registration
application.
The study, in general, shall be a randomized blind
controlled trial with an adequate sample size.
Phase IV Clinical Trial: a new drug
post-marketing study. The purposes are to assess
therapeutic effectiveness and
adverse
reactions when a drug is widely used, to evaluate
overall benefit-risk relationships of the drug
when used
among general population or
specific groups, and to adjust the administration
dose, etc.
Bioequivalence study refers
to a human study, which applies bioavailability
study methods with pharmacokinetic
parameters as indicators to compare
active ingredient absorption rate and extent of
the preparations in the same or
different dosage forms of a drug in
terms of statistical differences under the same
experimental condition.
Article 32 The
sample size of a drug clinical trial shall conform
to the objectives of the clinical trial and
fulfill
statistical requirements, and
shall be no smaller than the minimum number of
subjects required by the Annex of
the
Provisions.
Where
there
are
circumstances,
regarding
rare
or
special
diseases,
etc.,
which
request
clinical
sample size
reduction or clinical trial exemption, a request
shall be made
with the clinical trial
application, and
reviewed and approved
by the State Food and Drug Administration.
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Article 33 As for vaccines prepared
during bacterial or viral strain screening or
other special drugs, if confirmed
without any suitable animal
model and laboratory
measurement in terms of curative
effectiveness, clinical trials
may be
applied for to the State Food and Drug
Administration, subject to ensuring the safety of
trial subjects.
Article 34
When a drug clinical trial is approved, the
applicant shall select institutions for the
clinical trial from
those certified for
conducting drug clinical trials.
Article
35
Drugs
used
for
clinical
trials
shall
be
manufactured
in
facilities
in
compliance
with
the
Good
Manufacturing
Practice
for
Pharmaceutical
Products
(GMP).
The
manufacturing
process
shall
strictly
meet
the
requirements of the GMP.
The
applicant shall be responsible for the quality of
the drugs used for clinical trials.
Article 36 The applicant may conduct
the testing for clinical trial drugs by itself, or
entrust a drug testing institute
specified
in
the
Provisions
to
conduct
such
testing,
according
to
its
proposed
specifications.
Vaccines,
blood
products and other
biological products specified by the State Food
and Drug Administration shall be tested by drug
testing institutes designated by the
State Food and Drug Administration.
A
drug can be used for a clinical trial only after
tested as qualified.
Drug regulatory
departments may conduct sampling and testing on
drugs used for clinical trials.
Article
37 Prior to conducting a clinical trial, the
applicant shall report to the State Food and Drug
Administration
for record while copying
to the drug regulatory department of the seat of
the clinical trial institution and that of the
province, autonomous region or
municipality directly under the Central Government
to receive the application a
confirmed
clinical trial protocol, the name of the principal
investigator at the institution in charge of the
clinical
trial, a list of participating
institutions and names of investigators wherefrom,
an ethic committee approval letter,
and
a template of the informed consent form, etc.
Article 38 Where the applicant finds a
clinical trial institution violating relevant
regulations or failing to implement
the
clinical
trial
protocol,
it
shall
urge
the
institution
to
make
corrections;
if
the
circumstances
are
serious,
the
applicant may demand suspension or
termination of the clinical trial, and shall
report the matter to the State Food
and
Drug Administration and the drug regulatory
departments of the relevant provinces, autonomous
regions or
municipalities directly
under the Central Government.
Article
39
After completion of a clinical
trial, the applicant shall submit a clinical trial
final report, a statistical
analysis
report and its database to the State Food and Drug
Administration.
Article 40 A clinical
trial shall be conducted within three years after
approval. If overdue, the original approval
documents shall be invalid. If the
clinical trial is still needed, the application
shall be reapplied for.
Article 41 If
any serious adverse event occurs during the
clinical trial, the investigators shall report to
the drug
regulatory departments of the
relevant provinces, autonomous regions or
municipalities directly under the Central
Government and the State Food and Drug
Administration and notify the applicant within 24
hours, and report to
the ethic
committee in time.
Article 42 In any of
the following circumstances during a clinical
trial, the State Food and Drug Administration
may order the applicant to modify the
protocol, suspend or terminate the clinical
trial,:
(1) the ethic committee fails
to perform its duty;
(2) safety of the
subjects cannot be adequately ensured;
(3) a serious adverse event is not
reported within the specified timeline;
(4) there is evidence to
prove that the drug used for the clinical trial is
not effective;
(5) a quality problem of
the drug used for the clinical trial occurs;
(6) there is a fraud in the clinical
trial; or
(7) there is any
other case violating the Good Clinical Practice.
Article 43 Where there is any large-
scale of and unexpected adverse reaction or
serious adverse event, or there is
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evidence
to
prove
any
serious
quality
problem
of
the
drug
used
for
a
clinical
trial,
the
State
Food
and
Drug
Administration
or
the
drug
regulatory
department
of
the
province,
autonomous
region
or
municipality
directly
under the Central
Government may take emergency control measures and
order to suspend or terminate the clinical
trial. The applicant and clinical trial
institution must stop the clinical trial
immediately.
Article
44
An
overseas
applicant
intending
to
conduct
an
international
multi-center
clinical
trial
in
China
shall
submit an application to the State Food
and Drug Administration in accordance with the
Provisions, and fulfill the
following
requirements:
(1) the drugs used for
clinical trials shall be already approved or in
phase II or III clinical trial overseas. The State
Food
and
Drug
Administration
does
not
accept
any
overseas
applicant’s
international
multi
-center
clinical
trial
application for any preventive vaccine
not being registered overseas yet;
(2)
while approving to conduct an international multi-
center clinical trial, the State Food and Drug
Administration
may require the
applicant to conduct phase I clinical trial first
in China;
(3) when conducting an
international multi-center clinical trial in
China, if there are any observed serious adverse
reaction
and
unexpected
adverse
reaction
associated
with
the
drug
in
any
country,
the
applicant
shall,
in
accordance with relevant regulations,
report to the State Food and Drug Administration
in time;
(4) the applicant shall submit
a complete clinical trial report to the State Food
and Drug Administration after the
completion of a clinical trial; and
(5) the data obtained from an
international multi-center clinical trial for drug
registration application in China shall
be
in
conformity
with
the
requirements
on
clinical
trial
in
the
Provisions.
All
the
study
materials
of
the
international multi-center clinical
trial shall be submitted.
Chapter IV
Application and Approval of New Drugs
Article 45 The State Food and Drug
Administration may implement special review and
approval in cases of the
following
applications:
(1) active ingredients
extracted from plants, animals and minerals, etc.
and their preparations not yet marketed in
China, and newly discovered Chinese
crude drugs and their preparations;
(2)
chemical
drug
substances
and
their
preparations
and
biological
products
not
yet
approved
for
marketing
in
China or abroad;
(3) new
drugs for the treatment of diseases such as AIDS,
malignant tumors and rare diseases, etc. with
significant
clinical advantage; and
(4) new drugs for the treatment of
diseases, for which effective therapeutic methods
are not available.
For drugs specified
in the previous clause, applicants may apply for
special review and approval in the process of
drug registration. The Center for Drug
Evaluation of the State Food and Drug
Administration shall organize expert
meetings to discuss and determine
whether or not to conduct special review and
approval for the drugs.
Specified
measures for special review and approval shall be
formulated separately.
Article 46 Where
a new drug is co-developed by several
institutions, the registration can be applied for
by one of
the institutions, and its
duplicate application shall not be made by the
others. If a joint application for registration is
needed,
the
institutions
shall
co-sign
as
the
applicant
of
the
new
drug.
Each
approved
new
drug,
including
its
different strengths
shall be produced by only one institution.
Article 47 For the registration
application to change the dosage form without
changing administration route of a
marketed drug, new techniques shall be
employed to improve the drug quality and safety,
and the changed dosage
form shall have
significant clinical advantage compared with the
previous dosage form.
Registration
applications to change the dosage form without
changing the route of administration or to claim
any
new
indication
shall
be
submitted
by
certified
manufacturers,
with
exceptions
for
special
dosage
forms
such
as
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targeting delivery, sustained release
and controlled release preparations, etc.
Article 48 In the process of the review
and approval of a new drug, the registration
classification and technical
requirements
thereof
shall
not
be
changed,
even
though
the
preparations
of
the
same
active
ingredients
are
approved for marketing abroad.
In the process of the review and
approval of a new drug, the registration
classification and technical requirements
thereof shall not be changed, even
though the preparations of the same active
ingredients applied for by domestic
manufacturers are approved for
marketing in China.
Article 49 The
dossier for drug registration application shall be
submitted at one time. No other technical
materials
should
be
added
by
the
applicant
after
a
drug
registration
application
is
accepted,
with
the
exceptions
for
applications
of
special
review
and
approval,
new
finding
regarding
drug
safety,
or
supplementary
materials
as
required. Where an
applicant deems it integrant for any new technical
material to be supplemented, the submitted
application shall be withdrawn. Only if
no same product is in the new drug observation
period, the applicant may
re-apply in
compliance with the relevant requirements in the
Provisions.
Section 1
Clinical Trials for New Drugs
Article
50
After
completing
the
pre-clinical
study,
the
applicant
shall
fill
the
Application
Form
for
Drug
Registration,
and
report
authentically
relevant
materials
to
the
drug
regulatory
department
of
the
province,
autonomous region or municipality
directly under the Central Government where the
applicant is located.
Article
51
Drug
regulatory
departments
of
provinces,
autonomous
regions,
or
municipalities
directly
under
the
Central Government shall
conduct the preliminary review of the application
dossiers, and issue a acceptance notice
of drug registration application if
requirements are met, or issue a non-acceptance
notice, in which reasons shall be
given, of drug registration application
if requirements are not met.
Article
52
Drug
regulatory
departments
of
provinces,
autonomous
regions,
or
municipalities
directly
under
the
Central Government shall
organize to conduct on-site inspections of the
drug research and development conditions
and raw data, make preliminary review
of the submitted dossiers, and provide review
opinions within five days
from the date
it accepts an application. Where the drug for
which the registration is applied is a biological
product,
samples from three production
batches thereof shall also be collected for
testing, and a notice for the testing for
registration shall be issued to the
drug testing institute.
Article
53
Drug
regulatory
departments
of
provinces,
autonomous
regions,
or
municipalities
directly
under
the
Central Government shall
deliver the review opinions, inspection reports
and the application dossiers to the Center
for
Drug
Evaluation
of
the
State
Food
and
Drug
Administration
within
the
specified
timeline,
and
notice
the
applicants.
Article
54
The
drug
testing
institute
that
receives
a
notice
for
the
testing
for
registration
shall
test
the
samples
according
to
the
drug
specifications
submitted
by
the
applicant,
verify
the
submitted
drug
specifications,
and
submit a certificate of
analysis for drug registration to the Center for
Drug Evaluation of the State Food and Drug
Administration within the specified
timeline, and copy to the applicant.
Article
55
After
receiving
submitted
dossiers,
the
Center
for
Drug
Evaluation
of
the
State
Food
and
Drug
Administration shall
organize pharmaceutical, medical and other
technical personnel to conduct technical review
of
the
submitted
dossiers
within
the
specified
timeline,
and
may
request,
with
reasons,
applicants
to
provide
supplementary materials when necessary.
After completing technical reviews, the Center for
Drug Evaluation shall
give
technical
review
opinions
and
report
together
with
relevant
documents
to
the
State
Food
and
Drug
Administration.
The State Food and Drug Administration
shall make review and approval decisions based on
the technical review
opinions.
Where
the
regulations
are
conformed
to,
a
Drug
Clinical
Trial
Approval
shall
be
issued;
where
the
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regulations are not conformed to, a
Disapproval Notice shall be issued with reasons
provided.
Section 2
Production of New Drugs
Article 56 After completing drug
clinical trials, applicants shall fill the
Application Form for Drug Registration,
submit production application dossiers
to the drug regulatory departments of the
provinces, autonomous regions,
or
municipalities
directly
under
the
Central
Government
where
the
applicant
is
located,
and
at
the
same
time
provide the raw materials and research
information for preparing reference standards to
the National Institute for
the Control
of Pharmaceutical and Biological Products.
Article
57
Drug
regulatory
departments
of
provinces,
autonomous
regions,
or
municipalities
directly
under
the
Central
Government
shall
conduct
the
preliminary
review
of
the
application
dossiers,
and
issue
an
acceptance
notice of drug
registration application if requirements are met,
or issue a non-acceptance notice, in which reasons
shall be given, of drug registration
application if requirements are not met.
Article
58
Drug
regulatory
departments
of
provinces,
autonomous
regions,
or
municipalities
directly
under
the
Central Government shall
organize to conduct on-site inspections of the
drug research and development conditions
and raw data, make preliminary review
of the submitted dossiers, and provide review
opinions within five days
from the date
it accepts an application. For the other drugs
except biological products, samples of three
production
batches
shall
also be
collected
for
testing,
and
a
notice
of
specifications verification
shall be
issued
to
the drug
testing institute.
Drug
regulatory
departments
of
provinces,
autonomous
regions,
or
municipalities
directly
under
the
Central
Government
shall
deliver
the
review
opinions,
inspection
reports
and
the
application
dossiers
to
the
Center
for
Drug
Evaluation
of
the
State
Food
and
Drug
Administration
within
the
specified
timeline,
and
notice
the
applicants.
Article 59 Drug
testing institutes shall verify the submitted drug
specifications and give the verification opinions
to
the Center for Drug Evaluation of
the State Food and Drug Administration within the
specified timeline, and at the
same
time
copy
to
the
drug
regulatory
departments
of
the
provinces,
autonomous
regions,
or
municipalities
directly under the Central Government
that notify them to conduct the verification, and
the applicants.
Article
60
After
receiving
submitted
dossiers,
the
Center
for
Drug
Evaluation
of
the
State
Food
and
Drug
Administration shall organize
pharmaceutical, medical and other technical
personnel to conduct technical review
of
the
submitted
dossiers
within
the
specified
timeline,
and
may
request,
with
reasons,
applicants
to
provide
supplementary materials when necessary.
Where the regulations are conformed to
as reviewed, the Center for Drug Evaluation of the
State Food and Drug
Administration
shall notice the applicant to apply for production
site inspection and inform the Center for Drug
Certification of the State Food and
Drug Administration. Where the regulations are not
conformed to as reviewed,
the Center
for Drug Evaluation of the State Food and Drug
Administration shall report the review opinions
and
relevant
documents
to
the
State
Food
and
Drug
Administration;
the
State
Food
and
Drug
Administration
shall
make a disapproval
decision to the application based on the technical
review opinions, and issue a Disapproval
Notice with reasons.
Article
61 The applicant shall apply for on-site
inspection to the Center for Drug Certification of
the State Food
and Drug Administration
within six months from the date it receives the
notice of production site inspection.
Article 62 The Center for Drug
Certification of the State Food and Drug
Administration shall, within 30 days from
the date it receives the application
for production site inspection, organize on-site
inspection of large-scale samples
production, verify the applicability of
the manufacturing processes and at the same time
take samples of one batch
of products
(samples of three batches of products for
biological products), and provide production site
inspection
report to the Center for
Drug Evaluation of the State Food and Drug
Administration within ten days after the site
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inspection.
Article
63
Samples
shall
be
produced
at
a
plant
with
the
GMP
Certificate.
As
for
a
new
manufacturer,
a
new
workshop established or
the production of a dosage form added at an
existing manufacturer, the sample production
shall meet the GMP requirements.
Article 64 Drug testing institutes
shall conduct sample testing according to the
verified specifications, and within
the
specified
timeline,
provide
testing
reports
to
the
Center
for
Drug
Evaluation
of
the
State
Food
and
Drug
Administration,
and
copy
to
the
relevant
drug
regulatory
departments
of
the
provinces,
autonomous
regions,
or
municipalities directly
under the Central Government and the applicants.
Article
65
The
Center
for
Drug
Evaluation
of
the
State
Food
and
Drug
Administration
shall
make
a
general
opinion based on the
technical review opinions, production site
inspection reports and sample testing results, and
report the general opinion together
with relevant documents to the State Food and Drug
Administration. The State
Food and Drug
Administration shall make a review and approval
decision based on the general opinion. Where the
regulations
are
conformed
to,
a
New
Drug
Certificate
shall
be
issued;
if
the
applicant
already
has
a
Drug
Manufacturing
Certificate and possesses the production
conditions, a drug approval number shall be issued
at the
same time; where the regulations
are not conformed to, a Disapproval Notice shall
be issued with reasons.
A New Drug
Certificate shall not be issued to the approved
registration applications for changing dosage
forms
without changing route of
administration or claiming for new indications,
with exceptions for special dosage forms
such as targeting delivery, sustained
release and controlled release preparations, etc.
Section 3
New Drug
Observation Period
Article 66 In order
to protect the public health, the State Food and
Drug Administration may set an observation
period for any new drug approved for
production. The observation period of a new drug
shall be no longer than
five years from
the date the drug is approved for production.
During
the
observation
period
of
a
new
drug,
the
State
Food
and
Drug
Administration
shall
not
approve
other
manufacturers to produce, change dosage
form of or import the drug.
Article 67 A drug manufacturer shall
investigate the manufacturing processes, quality,
stability, therapeutic effect
and
adverse
reactions,
etc.
of
a
new
drug
in
the
observation
period,
and
report
annually
to
the
drug
regulatory
department of the
province, autonomous region, or municipality
directly under the Central Government, where it is
located.
Where
a
drug
manufacturer
fails
to
perform
its
duties
in
the
observation
period,
the
drug
regulatory
department of the
province, autonomous region, or municipality
directly under the Central Government shall order
it to make rectifications.
Article
68
Where
institutions
for
drug
manufacturing,
distribution,
use,
testing
or
supervision
find
any
critical
quality
problem,
serious
or unexpected
adverse
reaction
of
a
new
drug,
they
shall
report
to
the
drug
regulatory
department of the province, autonomous
region, or municipality directly under the Central
Government in time.
Once
receiving
the
report,
the
drug
regulatory
department
of
a
province,
autonomous
region,
or
municipality
directly under the Central Government
shall organize prompt investigation, and report to
the State Food and Drug
Administration.
Article
69
Where
a
drug
manufacturer
does
not
conduct
production
of
the
new
drug,
for
which
an
observation
period is set,
within two years from the date of the approval,
the State Food and Drug Administration may approve
the application of another drug
manufacturer to produce the new drug and reset the
observation period of the drug.
Article
70 Starting from the date a new drug enters the
observation period, any other application for the
clinical
trial
of
the
same
drug
already
approved
by
the
State
Food
and
Drug
Administration
may
proceed
along
drug
registration
application, review and approval procedures; where
regulations are conformed to, the State Food and
Drug Administration shall approve the
production or importation of the same drug. The
observations of the drugs
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produced by the domestic
manufacturers should be conducted
together with the drug already in the observation
period.
Article 71 Starting
from the date a new drug enters the observation
period, other registration applications for the
same drug shall no longer be accepted.
The other applicants’ applications for the same
drug already accepted but
not yet
approved for clinical trials shall be returned;
upon the expiration of the observation period of
the drug, the
registration of a generic
or import drug may be applied for.
Article 72 Where an application for an
import drug registration is approved first, the
domestic application already
approved
for
clinical
trial
of
the
drug
may
proceed
along
drug
registration
application,
review
and
approval
procedures;
where
regulations
are
conformed
to,
the
State
Food
and
Drug
Administration
shall
approve
the
production of the drug; or, the
applicant may withdraw the application, and submit
a generic drug application. The
other
applications for the same drugs already accepted
but not yet approved for clinical trials shall be
returned; the
registration of a generic
drug may be applied for.
Chapter V
Application and Approval of Generic
Drugs
Article 73 The applicant applying
for registration of a generic drug shall be a drug
manufacturer. The applied drug
shall be
within the production scope specified in the Drug
Manufacturing Certificate.
Article
74
The
generic
drug
shall
have
the
identical
active
ingredients,
route
of
administration,
dosage
form,
strength
and
therapeutic
effects
with
the
registered
drug.
Where
a
drug
has
been
produced
by
more
than
one
manufacturer, the
selection of registered drugs for comparative
study shall be in accordance with relevant
technical
guidelines.
Article 75 To apply for the
registration of a generic drug, the applicant
shall fill the Application Form for Drug
Registration, submit relevant dossiers
and apply for production site inspection to the
drug regulatory department of
the
province,
autonomous
region,
or
municipality
directly
under
the
Central
Government
where
the
applicant
is
located.
Article
76
Drug
regulatory
departments
of
provinces,
autonomous
regions,
or
municipalities
directly
under
the
Central
Government
shall
conduct
the
preliminary
review
of
the
application
dossiers,
and
issue
an
acceptance
notice of drug
registration application if requirements are met,
or issue a non-acceptance notice, in which reasons
shall be given, of drug registration
application if requirements are not met.
As for a drug for which the protection
of traditional Chinese medicine preparations has
been applied, from the date
the
application for the protection is accepted through
the date an administrative decision is made, the
acceptance of
the application of its
generic drug shall be suspended.
Article
77
Drug
regulatory
departments
of
provinces,
autonomous
regions,
or
municipalities
directly
under
the
Central Government shall
organize to conduct on-site inspections of the
drug research and development conditions
as
well
as
raw
data,
and
production
site
inspections
according
to
the
manufacturing
processes
and
quality
specifications provided by the
applicant, and take samples of three consecutive
batches of products, and send to the
drug testing institutes for testing
within five days starting from the date they
accept an application.
The production
of samples shall be in conformity with the
requirements in Article 63 in the Provisions.
Article 78 Drug regulatory departments
of the provinces, autonomous regions, or
municipalities directly under the
Central Government shall review the
submitted dossiers within the specified timeline
and give review opinions.
Where the
regulations are conformed to, they shall provide
for the Center for Drug Evaluation of the State
Food
and Drug Administration with the
review opinions, the check report, the production
site inspection report and the
application
dossiers,
and
inform
the
applicant.
Where
the
regulations
are
not
conformed
to,
they
shall
issue
a
Disapproval Notice with reasons, and
notify the drug testing institute to terminate the
testing for registration.
Article
79
Drug
testing
institutes
shall
conduct
sample
testing,
provide
testing
reports
to
the
Center
for
Drug
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Evaluation
of
the
State
Food
and
Drug
Administration
within
the
specified
timeline,
and
copy
to
the
drug
regulatory
departments
of
the
provinces,
autonomous
regions,
or
municipalities
directly
under
the
Central
Government that notify them to conduct
the verification, and the applicants.
Article
80
The
Center
for
Drug
Evaluation
of
the
State
Food
and
Drug
Administration
shall
organize
pharmaceutical, medical and other
technical personnel to conduct technical review of
the submitted dossiers within
the
specified
timeline,
and
may
request,
with
reasons,
applicants
to
provide
supplementary
materials
when
necessary.
Article
81
The
Center
for
Drug
Evaluation
of
the
State
Food
and
Drug
Administration
shall
make
a
general
opinion based on the
technical review opinions, production site
inspection reports and sample testing results, and
report the general opinion together
with relevant documents to the State Food and Drug
Administration. The State
Food and Drug
Administration shall make a review and approval
decision based on the general opinion. Where the
regulations are conformed to, it shall
issue a drug approval number or a Drug Clinical
Trial Approval; where the
regulations
are not conformed to, it shall issue a Disapproval
Notice with reasons.
Article 82 After
completing drug clinical trials, applicants shall
submit clinical trial data to the Center for Drug
Evaluation of the State Food and Drug
Administration. The State Food and Drug
Administration shall issue a drug
approval number or a Disapproval Notice
based on the technical review opinions.
Article 83 As for a marketed drug with
confirmed safety problems, the State Food and Drug
Administration may
decide to suspend
the acceptance or review and approval of the
application of its generic drugs.
Chapter VI
Application and
Approval of Import Drugs
Section 1
Registration of Import Drugs
Article 84 A drug being applied for
importation shall have already obtained the drug
marketing authorization in the
producing
country
or
region
where
the
overseas pharmaceutical
manufacturer
is
located;
those
not
yet
obtained
marketing authorization in the
producing country or region, however confirmed
with safety, efficacy and clinical
needs by the State Food and Drug
Administration may be approved for importation.
The production of a drug applied for
importation shall comply with the GMP requirements
of both the producing
country or region
where the drug manufacturer is located and China.
Article 85 To apply for import drug
registration, the applicant shall fill the
Application Form for Drug Registration,
submit relevant dossiers and samples,
provide relevant approval documents, and submit
the application to the State
Food and
Drug Administration.
Article
86
The
State
Food
and
Drug
Administration
shall
conduct
the
preliminary
review
of
the
application
dossiers, and
issue an acceptance notice of drug registration
application and notify the National Institute for
the
Control
of
Pharmaceutical
and
Biological
Products
to
conduct
testing
for
registration
of
samples
from
three
batches if
requirements are met; or issue a non-acceptance
notice of drug registration application with
reasons if
requirements are not met.
The
State
Food
and
Drug
Administration
may
organize
to
conduct
on-site
inspection
of
development
and
production conditions, and take
samples.
Article
87
The
National
Institute
for
the
Control
of
Pharmaceutical
and
Biological
Products
shall
organize
to
conduct the testing for drug
registration within five days from the date it
receives the dossiers and samples.
Article 88 The drug testing institutes
undertaking the import drug testing shall complete
the testing for registration
and
submit
the
certificate
of
analysis
for
drug
registration
to
the
National
Institute
for
the
Control
of
Pharmaceutical
and
Biological Products
within
60
days
from
the
date
they
receive
the
documents,
samples
and
relevant reference
standards.
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