Synopsis
This
is the second guidebook of the China Pharmaceutical Guidebook Series. It will
provide a detailed introduction of CFDA’s requirements for materials and
clinical trials of application and approval for imported chemical drug
registration, including radioactive pharmaceuticals.
Summary
In
China, like in other Western countries, the pharmaceutical authority ----- the
State Food and Drug Administration (hereinafter called as SFDA) requests
applicant to submit complicate and reliable materials for application of drug
registration. The SFDA stipulated the classification of drug registration in
order to administer the application of chemical drug registration. At the same
time, the SFDA collected the materials for application of chemical drug
registration into four categories and 32 items in accordance with various
chemical drug categories. When an application of chemical drug registration is
filed, the SFDA will request applicant to not only submit designated material
items in accordance with prescribed category of chemical drug to apply for registration,
but also conduct the clinical trials for certain categorical chemical drugs.
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This
is the second guidebook of the China Pharmaceutical Guidebook Series. It will
provide a detailed introduction of SFDA’s requirements for materials and
clinical trials of application and approval for imported chemical drug
registration, including radioactive pharmaceuticals.
Chapter
2 provides an overview of the classification of drug registration that is
formulated by the SFDA. To understand this classification of drug registration
only is the first step for an application of chemical drug registration,
because applicant must file the application in accordance with this
classification of drug registration.
Chapter
3 addresses the material items for application of chemical drug registration.
The SFDA collected all materials for application of chemical drug registration
into four categories and 32 items. There are the summary materials, the
research materials of pharmaceutics, the research materials of pharmacology and
toxicology, and the materials of clinical investigation. For administrative
requirement of chemical drug registration, the SFDA provides the detailed
explanations for many material items and precedes the ordinal numeral for each
material item. When an application is filed, the SFDA will request applicant to
submit the materials for application of chemical drug registration of various
categories in accordance with the material item’s ordinal numeral. Therefore,
to understand the material items is the second step for application of chemical
drug registration.
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Chapter
4 introduces the requirements of material items for application of chemical
drug registration in terms of the form of material items and their explanatory
notes. The form of material items represents the current requirements of
material items for application of chemical drug registration stipulated by the
SFDA. The explanatory notes further explain the requirements of material items
for various categorical chemical drugs. To understand the contents of this
section is a core for application of chemical drug registration. The
application of imported chemical drug registration must accord with the
material items prescribed by the form of material Items and the explanatory
notes to submit materials.
Chapter
5 addresses the requirements of clinical trial for application of chemical drug
registration. There are two parts, i.e. the general requirements of clinical
trial and the special requirements of clinical trial for imported chemical
drug.
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Chapter
6 introduces the material and clinical trial requirements for application of
radioactive pharmaceuticals, from the definitions, the requirements of material
items, the explanatory notes of material items to the requirements of clinical
trial.
The
guidebook concludes in chapter 7 by highlighting the significant suggestions
for overseas pharmaceutical manufacturers and producers looking to achieve a
successful application for their chemical drug registration in China. Last, the
appendices in chapter 8 include the Drug Administration Law of the People’s
Republic of China, the Regulations for Implementation of Drug Administration
Law of the People’s Republic of China, the Chinese Good Clinical Practice of
Pharmaceutical Products, the Application Form of Imported Drug Registration,
references, and description of Access China Management Consulting Ltd. After
have skimmed through this guidebook, audience can be clearly aware of the
latest Chinese regulations on requirements of the materials and the clinical
trials for application of imported chemical drug registration. For the detailed
pathway and procedure for application and approval of imported drug
registration, audience can learn from the first guidebook of the China
Pharmaceutical Guidebook Series (2013 Edition) ---- Latest Chinese Regulations
for Imported Drug Registration: A Comprehensive Guidebook for Foreign
Pharmaceutical Companies.
Scope
This
is the second guidebook of the China Pharmaceutical Guidebook Series. It will
provide a detailed introduction of CFDA’s requirements for materials and
clinical trials of application and approval for imported chemical drug
registration, including radioactive pharmaceuticals, from the classification of
drug registration, the material items for application of chemical drug
registration, the requirements of clinical trial for application of chemical
drug registration to the material and clinical trial requirements for
application of radioactive pharmaceuticals.
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