Summary
The
traditional medicines in Orient, especially, the traditional Chinese medicines
are always regarded by occidental as mysterious medicines. Until today not only
the chemical composition of traditional Chinese medicines almost can not been
expressed by a precise chemical structural formula, but also the indications of
the majority of traditional Chinese medicines still can not been clearly
described by the modern medical terminologies. How the Chinese drug authorities
to administer the registration application for such mysterious traditional
Chinese medicines? This is the fourth guidebook of the China Pharmaceutical
Guidebook Series. It will provide a detailed introduction of the Chinese
pharmaceutical authorities’ requirements for materials and clinical trials of
application and approval for imported traditional Chinese medicine. The Chinese
pharmaceutical authorities collect the traditional Chinese medicines and the
natural medicines into a category for registration application. Therefore, this
guidebook will provide not only the introduction for registration application
of imported traditional Chinese medicines but for the natural medicines.
In
China, like in other Western countries, the pharmaceutical authority -----
China Food and Drug Administration (hereafter called CFDA) requests applicant
to submit complicate and reliable materials for application of medicine
registration. The CFDA stipulated the classification of medicine registration
in order to administer the application of traditional Chinese medicine and
natural medicine registration. At the same time, the CFDA collected the
materials for application of traditional Chinese medicine and natural medicine
registration into four categories and 33 items in accordance with various
medicine categories. When an application of traditional Chinese medicine and
natural medicine registration is filed, the CFDA will request applicant to not
only submit designated material items in accordance with prescribed category of
traditional Chinese medicines and natural medicines to apply for registration,
but also conduct the clinical trials for certain categorical traditional
Chinese medicines and natural medicines.
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Chapter
2 provides an overview of the classification of medicine registration that is
formulated by the CFDA. To understand this classification of medicine
registration only is the first step for an application of traditional Chinese
medicine and natural medicine registration, because applicant must file the
application in accordance with this classification of medicine registration.
Chapter 3 addresses the material items for application of traditional Chinese
medicine and natural medicine registration. The CFDA collected all materials
for application of traditional Chinese medicine and natural medicine registration
into four categories and 33 items, i.e. 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 traditional Chinese medicine and natural medicine registration,
the CFDA provides the detailed explanations for many material items and
precedes the ordinal numeral for each material item. When an application is
filed, the CFDA will request applicant to submit the materials for application
of traditional Chinese medicine and natural medicine 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 traditional
Chinese medicine and natural medicine registration. Chapter 4 introduces the
requirements of material items for application of traditional Chinese medicine
and natural medicine registration in terms of the form of material items and
their explanatory notes.
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The
form of material items represents the current requirements of material items
for application of traditional Chinese medicine and natural medicine
registration stipulated by the CFDA. The explanatory notes further explain the
requirements of material items for various categorical traditional Chinese
medicines and natural medicines. To understand the contents of this section is
a core for application of traditional Chinese medicine and natural medicine
registration. The application of imported traditional Chinese medicine and
natural medicine 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
traditional Chinese medicine and natural medicine registration. There are two
parts, i.e. the general requirements of clinical trial and the special
requirements of clinical trial for imported traditional Chinese medicines and
natural medicines. The guidebook concludes in chapter 6 by highlighting the
significant suggestions for overseas pharmaceutical manufacturers and producers
looking to achieve a successful application for their traditional Chinese
medicine and natural medicine registration in China. Last, the appendices in
chapter 7 include the Drug Administration Law of the People’s Republic of
China, the Regulations for Implementation of the Drug Administration Law of the
People’s Republic of China, the Chinese Good Clinical Practice of Pharmaceutical
Products, the Form of Registration Application for Imported Drug, 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 traditional Chinese medicine and natural medicine
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 ---- Latest Chinese
Regulations for Imported Drug Registration: A Comprehensive Guidebook for
Foreign Pharmaceutical Companies.
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