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Monday, 16 November 2015

Imported Chemical Drugs Industry 2015 Market Size, Share, trends and Forecast 2015

This is the second guidebook of the China Pharmaceutical Guidebook Series. It will provide a detailed introduction of CFDAs 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.

This is the second guidebook of the China Pharmaceutical Guidebook Series. It will provide a detailed introduction of SFDAs 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 items ordinal numeral. Therefore, to understand the material items is the second step for application of chemical drug registration.

Scope

This is the second guidebook of the China Pharmaceutical Guidebook Series. It will provide a detailed introduction of CFDAs 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.

Reasons To Buy
Companies wishing to enter a lucrative drug market in China.
Companies interested in understanding the latest Chinese regulations on application and approval for imported drug registration.
Senior executive officers engaging regulatory and registration affairs for drugs.

Key Highlights
An overview of the classification of drug registration formulated by the SFDA (The State Food and Drug Administration in China).
The material items for application of drug registration.
The requirements of material items for application of drug registration.
The requirements of clinical trial for application of drug registration.
The material and clinical trial requirements for application of radioactive pharmaceuticals
The significant suggestions for overseas pharmaceutical manufacturers and producers looking to achieve a successful application for their chemical drug registration in China.
Many useful resources of law and regulations, including the Drug Administration Law of the Peoples Republic of China, the Regulations for Implementation of the Drug Administration Law of the Peoples Republic of China, the Chinese Good Clinical Practice of Pharmaceutical Products, the Form of Registration Application for Imported Drug, and so on.


Table Of Content

Table of Contents.1

Preface.2

Chapter 1. Introduction.5

Chapter 2. Classification of Drug Registration.7

Chapter 3. Material Items for Application of Drug Registration.9

3.1. Summary Materials.9
3.2. Research Materials of Pharmaceutics.12
3.3. Research Materials of Pharmacology and Toxicology.14
3.4. Materials of Clinical Investigation.16


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Chapter 4. Requirements of Material Items for Application of Drug Registration.17

4.1. The Form of Material Items.17
4.2. The Explanatory Notes of Material Items.20


Chapter 5. Requirements of Clinical Trial for Application of Drug Registration.25

5.1. General Requirements of Clinical Trial.25
5.2. Special Requirements of Clinical Trial for Imported Drugs.28


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