China is expected to be the fourth largest pharmaceutical market by 2010 as the average annual growth rate of China market has been above 15% since 1978. In 2008, the total pharmaceutical market size (including Active Pharmaceutical Ingredients-API, chemical finished product, biological product, and Traditional Chinese Medicine) in China was around USD 100 billion, and the chemical finished product market size was around USD 30 billion. More and more overseas pharmaceutical manufacturers and producers expect to enter such drug market. The first obstacle faced is how to file the application for their imported drug registration with Chinese pharmaceutical authorities. Since the drug registration implemented by the Chinese pharmaceutical authorities on December 1, 2002, its regulatory regime has experienced countless changes, and has become increasingly compatible with international standards. In turn, its ongoing consolidation will eventually contribute to a healthier market environment. In July 2007, the Chinese pharmaceutical authorities promulgated the latest ""Measures for the Administration of Drug Registration"", and the latest ""Measures"" that entered into force since October 1, 2007. These ""Measures"" provide the latest detailed requirements and procedures of application and approval for imported drug registration.

In China, the process of application and approval for imported drug registration is very complex, because of  the exorbitant way the Chinese pharmaceutical authorities administer and control the process. These variable administrative measures and regulations lack transparency. Therefore, a reliable consulting firm with solid experiences and a comprehensive and thorough knowledge of the latest Chinese regulations for imported drug registration is an essential prerequisite to achieving  a successful application for the products entry into the Chinese drug market.

Jyton Consulting has developed to be a leading firm expertise on SFDA drug registration in China since 1997. We provide an efficent and  total solution for international companies to obtain both API (active pharmaceutical ingredients) and pharmaceuticals through procedures in efficient manner. With interdisciplinary teams and extensive internal resources, Jyton's regulatory affairs staff is flexible and responsive in helping API, chemical finished products, biological products, and Traditional Chinese Medicine companies prepare the necessary documentation, conduct clinical trial and SFDA submission to achieve SFDA certification for their products.

Let Jyton help you with these China Drug regulatory issues:

-      Information collection and intelligence property checking

-      Classification of the drug

-      Compile the technical file and registration dossier.

-      Professional translation

-      Register the packaging material

-      Determine applicable standards.

-      Instruct and optimize preclinical research

-      Conduct clinical research and testing

-      Clinical evaluation reporting

-      SFDA submission and communication.

Procedure for clinical trial approval

Procedure for SFDA import certification approval

Please contact us for more information on obtaining SFDA approval for your drugs in China.