Co-occurrence of decrease of generic drugs and increase of new drugs
It was introduced that supplementary applications of pharmaceutical product registration were under relatively balanced state in 2005-2013, while after the peak in 2005, the new applications fell back to level of below 5000 in these years after implementation of Measures for Administration of Drug Registration in 2007. The new applications were somewhat increased in 2013 and that in 2014 exceed 8000, meaning a higher expectation of the pharmaceutical industry for the registration and application.
The gradual decrease of the application of generic drug in recent years is largely associated with the revision of the Measures for Administration of Drug Registration in 2007, which increased the approval standards for generic drugs and required them to be completely consistent with the original products. The registration approval rate gradually declines due to the raise of the examination standards. Meanwhile, R&D of new drugs in China is under flourishing state, and the approval quantity of clinical research has been maintained under pretty good state: the approval quantity reached over 300 in 2013, especially for pharmaceutical products in some important therapeutic areas, such as anti-infectious agent, antineoplastic drug, circulatory system agent, digestive system agent, genitourinary system drug and endocrine system drug.
