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China Pharmaceutical Guidebook: Latest Chinese Regulations for Imported Drug Registration

MUMBAI, India, June 17, 2013 /PRNewswire/ --

Bharat Book Bureau presents China Pharmaceutical Guidebook: Latest Chinese Regulations for Imported Drug Registration (


China possesses a fourth population in the world and has one of the largest drug markets round the world. By 2012, sales on the Chinese drug market have reached RMB 926.1 billion (about US$147 billion) reported by the end of 2012. A series of factors, such as an increasingly ageing population, accelerating growth of the urban population as well as expansion of healthcare covering urban and rural, will grow the Chinese drug market with a growth rate over 20 percent per annum in the next three years. China is expected to become the second largest drug market in the world by 2015.

Since the reform and open door policy implemented by the Chinese authorities in the late 1970s, the door of the Chinese drug market began opening up to the world step by step, which gave a fillip to the imported drugs from overseas pharmaceutical manufacturers and producers. By 2012, sales of imported drugs have shared one fourth on the Chinese drug market. As China joins the World Trade Organization (WTO) and integrates more completely into the global economy, it will further open the door of a lucrative drug market for overseas pharmaceutical companies. More and more overseas pharmaceutical manufacturers and producers expect to enter such drug market and seize a larger part of it.

In China, the process of application and approval for imported drug registration is very complex, because the Chinese pharmaceutical authorities administer and control this process by exorbitant administrative measures and regulations. Moreover, these exorbitant administrative regulations are variable and lack transparency. Therefore, a comprehensive and thorough knowledge of the latest Chinese regulations for imported drug registration has become an essential prerequisite for overseas pharmaceutical manufacturers and producers to achieve a successful application for their product entry into the Chinese drug market.

The aim of this guidebook is to guide overseas pharmaceutical manufacturers and producers to achieve a successful application and approval for their imported drug registration.

Report Highlights

- A Comprehensive Guidance of Imported Drug Registration

The first segment provides a comprehensive guidance of imported drug registration, which introduces an overview of the main responsibilities and organization structure of the Chinese pharmaceutical authority. China Food and Drug Administration (CFDA). CFDA requests the applicant to submit complicate and reliable materials for application of imported drug registration.

- A Guidance of Registration Application for Imported Chemical Drug

The second segment provides a guidance of registration application for imported chemical drugs, which addresses CFDA's requirements for materials and clinical trials of application and approval for imported chemical drug registration, including radioactive pharmaceuticals.

- A Guidance of Registration Application for Imported Biological Products

The third segment provides provides a guidance of registration application for imported biological products. The biopharmaceutical industry is one of the burgeoning industries. In the field of biopharmaceuticals, vast knowledge awaits people to explore. The Biopharmaceuticals are diversified and complex

- A Guidance of Registration Application for Imported Natural Medicines and Traditional Chinese Medicines

The fourth segment provides a guidance of registration application for imported natural medicines and traditional Chinese medicines. 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 be expressed by a precise chemical structural formula, but also the indications of the majority of traditional Chinese medicines still cannot be clearly described by the modern medical terminologies.

Who should buy this report?

- 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.

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Category - Pharmaceutical

About Bharat Book Bureau

Bharat Book Bureau is the leading market research information aggregator that provides market research reports, industry analysis, company profiles, business reports, country reports, newsletters and online databases. Our clients include Corporate, Consulting firms, and Academic Institutions and Government departments across the globe. Bharat Book Bureau provides over a million reports from more than 400 publishers around the globe. The market research reports we provide, help global companies examine the different markets before setting up a business or expanding into different countries across the world. They give a complete perspective on the current market scenario, trends, segments and future outlook.

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