Regulatory highlights and
drug development in
China
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SUBMITTED TO :
DR. ARUN NANDA AND
DR.VIKAS BUDHWAR
ASSISTANT PROFESSOR
SUBMITTED BY:
SONALI MISHRA
M.PHARM (DRA)
7007
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CONTENTS

INTRODUCTION

CHINESE REGULATORY AUTHORITY

HIGHLIGHTS OF CHINA’S NEW PROVISION & OPPURTUNITIES FOR
DRUG REGISTRATION

DRUG REGISTRATION IN CHINA

CLINICAL TRIAL APPLICATION

CHINA IMPORT DRUGS LICENSE (CFDA) CERTIFICATE
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
REQUIREMENTS FOR APPROVAL OF IMPORTED DRUGS IN CHINA

REVIEW PROCESS FOR DRUG MARKETING AUTHORIZATIONS

DRUG REGISTRATION CERTIFICATE VALIDITY AND REREGISTRATION

ACCELERATED APPROVALS FOR DRUG REGISTRATION
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INTRODUCTION
CHINA - Growing and Distinctive Pharmaceutical market
China is one of the largest pharmaceutical markets in the world, but
the status is arguably due to the size of its population, as the market
is not yet mature. The combined forces of economic and
demographic development, government stimulus, and enhanced
health awareness among the public, market consolidation, and
improving R&D capability may help the country to grow into a more
sophisticated market within the next decade.
 China’s pharmaceutical drug market is constantly growing and is the
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second-largest
pharmaceutical industry in the world, after the United
States. It is estimated to reach $161.8 billion by 2023, with an
average growth rate of 5% in the coming years, taking a 30% share
of the global market.
 The acceleration of new drug access, changing regulatory
landscape of individual categories, the rapidly aging Chinese
society, and subsequently increasing medical needs provide a range
of opportunities for the pharmaceutical market.
 After 13 years, the Chinese regulatory has made several changes in
the rules and guidelines for registering drugs. These changes made
are to reduce the complexity and match up with the other global
regulators
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Chinese Regulatory Authority
The Regulatory Authority of People Republic of China is State Food and Drug
Administration (CFDA)former it is termed as (SFDA). In March 2013, the regulatory
body was re branded and restructured as the China Food and Drug Administration,
elevating it to a ministerial-level agency. The CFDA replaced a large group of
overlapping regulators with an entity similar to the Food and Drug Administration of
the United States, streamlining regulation processes for food and drug safety. The
China Food and Drug Administration is directly under the State Council of the
People's Republic of China, which is in charge of comprehensive supervision on the
safety management of food, health food and cosmetics and is the competent
authority of drug regulation in mainland China.
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SFDA
The State Food and Drug Administration (SFDA) (Chinese: 国家食
品药品监督管理局) is founded on the basis of the State Drug
Administration. The State Food and Drug Administration is directly
under the State Council of the People’s Republic of China, which is
in charge of comprehensive supervision on the safety management
of food, health food and cosmetics and is the competent authority of
drug regulation in mainland China.
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cFDA to NMPA
The China Food & Drug Administration (CFDA), now called the National Medical
Products Administration (NMPA), is responsible for medical devices, drugs, and
healthcare services. The organization is headquartered in Beijing, with offices in each
province.
The Center for Medical Device Evaluation (CMDE) is responsible for conducting the
dossier review during the medical device registration process.
The General Administration of Quality Supervision, Inspection, and Quarantine
(AQSIQ) conducts mandatory safety registration, certification, and inspection for
certain devices.
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
The National Medical Products Administration (NMPA) is the main
regulatory authority responsible for drug registration management,
formulating drug registration specifications, and organizing drug
registration review and approval.

NMPA’s Drug Evaluation Center (CDE) is responsible for the review of
drug clinical trial applications, drug marketing authorization applications,
supplementary applications, and drug re-registration applications for
overseas manufactured drugs.
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Highlights
of China’s new provisions and
opportunities for drug registration
 The 60 days of timeframe for CTA approval following
the global regulations.
 Clear timelines for review and approval for different
types of drug registration applications.
 Streamline processes between drug registration and
manufacturing authorization to ensure GMP.
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 Improvement of communications between the applicant and
Center for Drug Evaluation (CDE) for effective CTA process.
 The introduction of parallel risk-based site inspections and
lab tests registration conduction with the technical review.
 Breakthrough and the conditional approval during the clinical
trial stage, and the priority review during marketing approval
expediting drug registration and satisfying unmet medical
needs in China.
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Drug registration in China

The Marketing Authorization Holder (MAH) can submit
applications for drug clinical trials, drug marketing authorization,
re-registration, and supplementary applications. Along with these
duties, MAH can also handle various other duties.
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Medicinal product registration categories in China
The requirements to develop and register a medicinal product in
China depend on further classification:

Chemical medicine

Biological products

Traditional chinese medicine.
Each type is then classified into three registration categories, which
determine the materials that the applicant must provide as part of its
registration application example clinical trial application, marketing
authorization application, etc.
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For chemical medicines, registration categories are as
follows

Innovative drugs

Improved new drugs

Generics
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For biologics, registration categories are as follows

Innovative biological products

Improved new biological products

Marketed biological products (including biosimilars)
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The corresponding application materials
requirements are based on the product
characteristics, degree of innovation, and
review management needs of the registered
medicines.
The drug category in which an applicant
chooses to register decides the clinical trial
application review and approval process.
NMPA manages the clinical trial application.
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Steps involved in Registration of
Imported Drugs in China
Generic product registration can be carried out by an
agent in China. Overseas manufacturers of
pharmaceutical products without legal representation
in China are thus required to apply for product
registration through agent services. An application is
submitted to the CFDA, there by the review process
is done by CDE (Center for Drug Evaluation)
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General requirements for application
dossiers

The first page of the dossiers shall be a directory for application
items, which shall be arranged in order as per the “Provisions for
Drug Registration” (SFDA Order No. 28). Each dossier shall
indicate on its cover: the name of the drug and application item,
document item number, and the name, phone number and
address of contact person and the applicant.

All documents in the dossier shall be printed or copied in A4
size paper. The content shall be complete, standardized, clear,
without alteration, and the data must be real and reliable.
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
The documents shall be put in portfolio envelope(s), on which the application
classification, registration category, drug name, the envelope number of set X,
the total number of envelopes in the set, original or copy, the contact person,
phone number and the name of registration application agent shall be indicated.

Two sets of complete application dossiers (at least one set is in the original) and
one set of review documents in hard copy shall be submitted for registration
application. Four application forms (1 in the original and 3 in hard copy) shall be
separately put into each set of dossier (the original application form and a hard
copy shall be put in the set of the dossier in the original).
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
"Import Drug Registration Application Form": the drug registration application
form submission program could be downloaded from CFDA website
(www.cfda.gov.cn); the application form shall be filled in as required, printed and
saved, and shall be signed by the overseas applicant, and signed & sealed by its
domestic agent.

When mailing or submitting the application dossiers, the electronic version of the
application form shall be sent to the following e-mail address dedicated for drug
registration: slzx@cfda.gov.cn.
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 The data checking code on the electronic and
paper application form should be identical.
 Foreign language materials shall be
translated into Chinese.
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CLINICAL TRIAL APPLICATION
If your products nned not to be conducted
clinical trials and Application dossier are
appropriate ,you shall obtain IDL within 9-12
months after submission. If clinical trials must
be conducted ,the general procedure is :
Step 1 - Submitting an application and if
application dossier are appropriate ,you shall
obtain Clinical Trials Permission (CTP ) within
about 10-12 months after submission .
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 Step 2 - Conducting the clinical
trials ,if just carry out
bioequivalence trials ,it might be
take 3 to 6 months ,but other
clinical trials might be take more
than 1-1.5 yr to complete.
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 Step 3 - Submitting the Application
Dossier (include the reports of clinical
trials ) and if the applicatiom dossier are
appropriate ,you shall obtain IDL within
about 12 -18 months after submission.
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CHINA IMPORT DRUGS LICENSE (CFDA) CERTIFICATE
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Imported drug
registration process (after clinical
study)
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
The first step in this process is to submit an application to the
CFDA for a Clinical Trial Application (CTA). The CFDA will
conduct a preliminary review of the submission package and then
transfer the dossier to the Center for Drug Evaluation (CDE).

Reviewers with background in pharmaceuticals, pharmacology
and clinical study will run a technical review, while local
sample testing will also be conducted in parallel.
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
Few CTAs would pass through the CDE review in
one single round. However, most applications will
receive supplement notice(s) in writing to request
additional information for further assessment. In such
case, CDE will allow a 4-month period for applicant to
gather and submit additional requested information to
CDE. This entire CTA step usually takes at least 125
working days.
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 The second step in drug registration is
Production Application (or Imported Drug
License Application), which involves
submitting a clinical report and other relevant
dossiers to obtain an imported drug license.
The process itself is basically the same as the
CTA step. This second step will take
approximately 145 days.
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REQUIREMENTS FOR APPROVAL OF
IMPORTED DRUGS IN CHINA
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The review process for drug
marketing authorization

After completing the pre-clinical studies and clinical studies supporting the drug
registration, the applicant should submit the drug marketing authorization application
according to the requirements.

After the formal examination of the application materials, acceptance will be given if
they meet the requirements.

The Drug Evaluation Center (CDE) organizes pharmacy, medical, and other technical
personnel to review the accepted drug marketing authorization applications.

After the conclusion of the comprehensive review, issues a registration certificate for
drugs. If the conclusion of the comprehensive review is not passed, the application is
disapproved
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Drug registration certificate validity
and re-registration

The validity period of the drug registration certificate of drug
Marketing Authorization Holder is five years. During the validity
period, the MAH must take responsibility of the safety,
effectiveness and quality controllability of the listed drugs and
apply for drug re-registration six months prior the expiration of
the validity period.
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Accelerated approvals for drugs
registration
According to the regulation, NMPA initiated new drug review process and has
divided the approval process into the following four categories


Breakthrough approval
Priority review

Conditional approval

Special approval
The applicant needs to know for which category of drugs do these review
processes apply at which stage of drug development may apply.
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REFERENCES
 https://www.sfdachina.com/
 https://globalforum.diaglobal.org/issue/may-2020/revised-drug-
registration-regulation-brings-new-challenges-and-opportunitiesto-new-drug-clinical-trials-in-china/
 https://clinregs.niaid.nih.gov/country/china#timeline_of_review
 http://english.nmpa.gov.cn/2019-07/25/c_390615.htm
 https://credevo.com/articles/2021/02/25/china-drug-registration-
process/
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
https://www.researchgate.net/publication/303278910_Regulatory_requirements_
and_registration_process_of_Generic_Drugs_in_China

https://pharmaboardroom.com/legal-articles/amended-drug-registrationregulation-aims-to-strengthen-and-streamline-regulation-of-new-drugs/

http://www.sfdachina.com/infosort/11_1.htm

https://www.pacificbridgemedical.com/regulatoryservices/pharmaceutical/product-registration/china/
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