SFDA08 the admissibility of drug registration applications in 3413 than the 18 percent drop in 2007
At 19:23 on February 16, 2009 Source: Medicine Economic News
In the State Food and Drug Administration (SFDA) 2 on 11 news conference, Secretary for Registration of Pharmaceuticals for Zhang introduced the 2008 ratification of the drugs register. Zhang Wei in an analysis of the data register to declare that the drug registration tends to declare more rational drug development order gradually improved.

Register declaration normalized quantity

In 2008, SFDA received the application for Registration of Pharmaceuticals for 3413, with 2006 and 2007 compared to the same period decreased by 75% and 18%, largely due to generic drug applications and easy to form such a sharp drop in the number of applications due to generic drug application, respectively, which fell by 85% and 46%.
 
 
This reflects to some extent tend to register the beginning of the normal quantity declaration, register the applicant tends to be more rational, Drugs R & D order to improve gradually.

In addition, does not include raw material medicine, SFDA approved a total of 2008 clinical applications 434, which has 52 kinds of new compounds belonging; approved 165 applications for new drug production, involving 119 kinds of medicines, including a class of new drugs 5; the approval of generic drug production application for 1502, covering 614 kinds of drugs; approved 99 applications for import of medicines, involving 83 kinds of drugs.

Concerned about the major diseases of public health

Zhang said that in the drug registration work, for some treatment of AIDS, malignant tumors and other major diseases and public health crisis involving drugs, given the focus of attention.

In 2008, SFDA approved 37 domestic listed antineoplastic agents, of which 13 had not been in the domestic market for the sale of drugs; approved the import of 13 antineoplastic agents listed, 12 of them for the first time the approval of imports of antineoplastic agents; has also ratified 56 anti-tumor drugs to enter clinical trials.

In addition, SFDA also approved nevirapine lamivudine tablets and two generic anti-AIDS drugs in China application approved tenofovir fumarate tablets and马拉韦罗Second furostanol ester Topiramate tablets of two new anti-AIDS drugs import applications. In addition, the approval of six anti-AIDS drug to enter clinical trials, including an innovative anti-AIDS vaccine.

Hepatitis in our country the incidence rate has been high, has become a serious impact on the health of our people a major public health problem. In 2008, SFDA approved treatment for Hepatitis B, 12 kinds of domestic drug market. In addition, the treatment of six approved drugs for clinical hepatitis B, which is a new compound.

Zhang said that in order to deal with public health crises, SFDA has also taken some special measures for approval. "5.12" Wenchuan earthquake after the occurrence of earthquake relief in order to ensure the supply of urgently needed medicines, SFDA urgently needed medicines to the earthquake relief special examination and approval, in a very short time to complete the preservation solution of the red blood cells, blood preservation solution, such as the registration of drugs for approval.

In addition, the approval of the pandemic influenza virus vaccine for pandemic influenza outbreak at the time of the public to provide effective protection to prevent.

In 2009 to follow "strict, new, good" principle

At present, the transitional period the concentration of drugs basically completed the review process. Zhang said that the drug registration approval will be returned to normal work, the work of drug registration in 2009 followed the general principles are "strict", "new", "good" - strict control, strict standards; encourage innovation, based on innovation; good again fast, safe development.

Building in the regulations is to study the development of "natural drugs register management Supplementary Provisions," "standard management approach to drugs."

The sources of corruption in the safety aspects, on the one hand to strengthen risk management, strictly control market access drugs from the source to eliminate security risks, on the other hand, examining the introduction of DMF (drug master file quality of raw materials management) system, set up long-term mechanism, strengthen the raw materials, auxiliary materials, chemical intermediates and药包材management.

In addition, in phases, classification, step-by-step to comprehensively promote the "Plan of Action Drug Standards improve" the implementation of mechanisms to improve the survival of the fittest drugs.