Since My stake betting appthe implementation of the "Administrative Measures for Drug Registration", the newly revised "Drug Registration Management Measures" on October 1, 2007，We build around regulations、review approval、On -site check、Registration test、Risk management and other aspects to strengthen the supervision of the entire process of drug registration，After nearly two years of hard work，Get a certain amount of results in work，Pharmaceutical registration has experienced hilarious changes: the number of declarations has decreased significantly，The quality of declaration continues to improve，The application agency is more rational，Drug research and development presents a new situation。

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   From October 1, 2007 to the end of June 2009，The State Food and Drug Administration accepts a total of 4403 applications for drug registration，The number of annual declarations decreases 2/3。Where，84 innovative medicines、1682 generic drugs。

 

   In addition，New "Administrative Measures for Registration of Drugs" is implemented to this day，The ratio of the same variety declaration also decreased from 1: 6 in 2006 to 1: 3 this year，Chinese medicine has almost no repeated declaration phenomenon。

 

   From the approval situation，From January to June 2009, the State Food and Drug Administration approved 173 clinical applications for new drugs; 238 applications for new drug production，8 of them 8 new medicines; 1074 applications for generic drugs; 388 applications for imported drugs。

 

   To sum up，The total amount of drug registration is decreased，Repeat declaration reduction，The quality is significantly improved，Structure changes，This fully illustrates that the registration of drugs is gradually returning to normal，Drug research and development is increasingly in line with national conditions，My stake betting appthe implementation of the new "Administrative Measures for the Registration of Drugs" is correct，Reached the expected goal。

 

 

   In recent years，The State Food and Drug Administration has continuously deepened the review and approval system reform，The institutional system formed a complete laws and regulations and departmental rules and regulations，Set up a reasonable review procedure，Established an authoritative expert technical resource，Realized scientific review and approval of scientific review，Passive situation of completely reversing the approval of drug review and approval，The level of protection of drug safety has been improved from the source。

 

To solve the problem of outstanding problems in the management of drug registration，The National Food and Drug Administration actively and steadily carried out special rectification work in the development of drug development in accordance with the deployment of the State Council。Revisked 7,999 drug registration applications through the registration site inspection of 33,000 drugs; 4,337 approval numbers were canceled by conducting a drug approval number inspection;，Among them, 15,000 varieties are not approved (most of them are chemicals 5/6 category、Chinese medicine 8/9 category)，No approval Stake Sports Bettingstake betting apprate reaches 61%，These effective work，To a large extent standardized the order of drug registration，Purified the drug research and development environment，Remove the historical burden，Also clearly clear the obstacles for My stake betting appthe implementation of the "Administrative Measures for the Registration of Drugs"，Lile the foundation。
　　
   3. Take a number of policy measures to encourage drug research and development innovation

 

   Register for regulating drug technology for regulating drug technology，Guarantee drug safety、Effective and controllable quality，According to the relevant provisions of the Administrative Measures for the Registration of Drugs，Recently，The State Food and Drug Administration issued My stake betting appthe implementation of the "Regulations on the Management Regulations on Registration of Drug Technology Transfer"。It is the following "Supplementary Provisions of Chinese Medicine Registration Management"、"Regulations on the Management Regulations of Drug Registration site"、The fourth supporting document released after the "Special Administrative Regulations on the New Drug Registration"，Since then，my country's pharmaceutical registration management regulatory regulations system with the "Administrative Measures for Drug Registration" is initially formed，my country's drug registration has entered an encouragement innovation、Time to guide innovation。

 

   Encourage innovation、Guidance Innovation，This is reflected in multiple regulations documents and cooperates with each other to form a joint force，First，The newly revised "Administrative Measures for Drug Registration" strictly strictly the scope of the new drug certificate，Further increase the gold content of the new drug certificate。Second，In the "Regulations on the Management of Special Approval of New Drug Registration", early intervention、Preferred review、Multi -channel communication、Dynamic supplementary information and other measures encouragement、Support innovative drug research and development。third，The "Regulations on the Management Regulations of Drug Registration site inspection" stipulates strict registration on -site inspection and inspection requirements，It guarantees the authenticity of the application information，Maintenance of the fairness and seriousness of registration approval，Makes various encouragement and innovation policies can really be implemented。Fourth，In the "Supplementary Provisions of Chinese Medicine Registration Management" to encourage the development of new drugs in the field of new functions，also increases the connotation of "new drugs that have no effective treatment for treatment"，New medicines that are not collected in "The Indications' Certificate of NPMP [Functional Indications]"，The scope of special approval，Give full play to the treatment role of traditional Chinese medicine in terms of incurable diseases and new diseases。and take specific measures to broaden the formula of the composite Chinese medicine compound agent,Encourage Chinese medicine innovation and development。

 

   "Regulations on the Registration of Drug Technology Transfer Registration，Further encourage innovation，Promoting the reasonable allocation of resources to play an important role。

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   First, the number of approved numbers effectively controlled。After approval of technical transfer，The approval number that had been obtained at the same time was canceled at the same time，Avoid one transfer to multiple，Guide drug manufacturers to reduce the number of simplicity changes and quantity of dosage forms and imitation drugs，Fundamentally solve the problem of low level repetition。

 

   The second is to promote the degree of professionalization。Establishment of new policy for drug technology，It is conducive to changing product structure between enterprises or enterprises，Reasonable allocation and adjustment of production resources，Realize the reorganization and key My stake betting appstake betting appdevelopment of superior product products，Reduce low level duplication and homogeneity。With the improvement of product production，The level of professional production and supervision around the product will be promoted，Promote My stake betting appthe implementation of CGMP with products -core，Further guarantee product quality。

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   Third is to use technical means，Improve the technical threshold，Strengthen risk control。Regulations on the technical information required by the transfer and production technology transfer of new drugs，Basic reference to the requirements of generic drugs，made a significant increase，and emphasized the technical comparison before and after transfer。Added technical review procedures，Refer to the basic technical characteristics of changing the place of origin，Relative to the review of imitation drugs has improved the contrast and evaluation of technical review。The review of the review requires clinical trials or biological equivalent tests，Also complete the specified test，completely changed the status of the past new drug technology transfer without technical review and clinical trials，greatly improved technical requirements。Regulations also set up "not to be approved": For medicines that have confirmed safety issues by the State Food and Drug Administration，Its technical transfer registration application will not be accepted，Not approved if it has been accepted，to further strengthen risk control。

 

   Fourth, variety management has changed from "static" to "dynamic"。It is understood，At present, more than half of the approval number of many pharmaceutical manufacturers is idle，The variety produced all year round accounts for less than one -quarter of the proportion of the total approval number of the enterprise。On the one hand, a large number of approval number is idle，On the other hand, there are still a large number of pharmaceutical manufacturers apply for new registration approval number。The production technology caused by the approved number is not just a waste of social resources，And supervision of drug production、The re -evaluation and adverse reactions monitoring of the listing drugs are very unfavorable。High -quality drug supervision must be based on the normal production and normal sales of drugs，that is, on the basis of dynamic。Drug technology transfer，Especially production technology transfer，Drug production technology that the company does not use is transferred to other companies that need this variety，Optimized combination of product resources，Healthy development of the pharmaceutical industry。
　　
   The State Food and Drug Administration issued this regulation，It is to make technology as a product，Orderly circulate in the market，Encourage some technologies to transfer to the outside。Allow new medicine、Pharmaceuticals for many years、Imported drugs perform technical transfer under certain conditions，Encourage the application and promotion of advanced scientific research achievements and mature production technology，Let foreign advanced production technology be settled in China; it is conducive to the role of market allocation resources，It is conducive to the reorganization of product and resource advantages，bigger and stronger pharmaceutical industry。

    Fourth, improve the combination of elimination, improve the level of safety and quality

 

   (1) Accelerate My stake betting appthe implementation of stake betting appthe National Drug Standard Action Plan

 

   Party Central Committee、The State Council attaches great importance to the work of drug standards，and use it as an important livelihood project to catch。Central Finance arranged 1 billion funds in 2008 to increase the standards of 1,000 medicines，In 2009, it plans to arrange nearly 200 million fund support standards to improve the work，This is unprecedented。

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   The National Food and Drug Administration accelerated My stake betting appthe implementation of stake betting appthe National Drug Standard Action Plan in 2009，and formulated informative plans and arrangements，This standard is raised to varieties with high security risks such as injections、Ethnic medicine and the varieties listed in the national basic drug catalog。For varieties listed in the basic drug directory，Arrange standards to increase the standard，Ensure the quality of basic drugs and the safety of the public;，Especially the standard of traditional Chinese medicine injection，Increasing human and capital investment，It is planned to arrange 24.5 million yuan to increase the standard for ethnic medicines，Arrange 21 million yuan for the standards for the variety of traditional Chinese medicine injections。In addition to the country's enhanced capital investment，It also guides and encourages enterprises to actively participate in standards to improve the work through policy measures。For the active improvement of drug standards，Preferred to enter the National Pharmacopoeia，Evaluation of Classics，Standard cannot control quality，Use the standard elimination mechanism to gradually eliminate。Strive for a few years of hard work，Gradually achieve "biological product standards are in line with developed countries，Chemical drug standards have basically reached international standards，The quality of traditional Chinese medicine is safer、controllable "target。

 

 

   The Implementation Regulations of the Drug Administration Law stipulates that "the pharmaceutical approval number issued by the drug supervision and management department of the State Council、"Import Drug Registration Certificate"、"Medical Product Registration Certificate" is valid for 5 years。Validity period expires，You need to continue production or imported，It should be applied for re -registration at 6 months before the validity period expires。When the medicine is registered，It shall submit relevant information in accordance with the regulations of the State Council's Drug Supervision and Administration。Re -registration of drugs is one of the means of regulating the regulatory drugs established by relevant laws and regulations，It is the legal responsibility of the food and drug supervision department。

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   It should be said，Drug re -registration is a conventional work for drug registration and management。But because this re -registration is one of the special work in the "Notice of the General Office of the State Council on the National Rectification and Standardize the Drug Market Order Plan"，and the re -registration of the medicine must be checked with the drug approval number、Pharmaceutical production technology and prescription verification work combined，Therefore, it can be said，The re -registration of the medicine is the in -depth and continuation of the special rectification work。

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   In August this year, the State Food and Drug Administration issued the "Notice on Doing a Good Drug Reconstruction Examination and Approval"，Clarified the "Key points for the re -registration of medicines"，Started the drug re -registered review and approval work。
　　
   Drug re -registration is the production condition for re -registered varieties、Production enterprise performs the review of statutory duties and the requirements of drug approval documents to continue to complete the task。As long as the approval number is completed within the validity period，Products that have not occurred during the period，Theoretically, you can pass the re -registration approval。But for the re -registration conditions of the medicine，Resolutely not register again，and cancel its approval number after the validity period of the approval certificate is expired。

 

   Register this medicine for this time，Set 12 review points，Clarified the review and approval requirements，For any of the existence My stake betting appof no one,，Not registered My stake betting appagain。Re -registered work through the development of drugs，It will eliminate those who do not have production conditions、The quality is not guaranteed、Various varieties with high safety risks。As required until September 30 next year，The variety of all approval certification documents must be completed and registered，The varieties that are not approved will not be available for sale。Drug re -registration is mainly borne by provincial drug supervision and management departments。

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   Major illness and the registration approval of major illnesses and involving public health crisis drugs in the first half of this year

 

   While doing a good job of registering and approval of common diseases of drugs，The State Food and Drug Administration actively treats AIDS、Tumor and other major illnesses and registered approval of drugs involving drugs involving public health crises。

   1、Anti -AIDS drugs: In the first half of 2009, on the basis of existing anti -AIDS drugs，It also approved the import registration of the two drugs of Lateraville and according to his two drugs; approved a domestic compound preparation of Navavira Pinrami Divoff and a clinical trial of a Lamif fixed tablet. (Biological equivalent test)。

 

   2、Alzheimer's disease treatment drug: The current disease is a hot spot for research in the field of international drug development，It is also a medical problem that has not yet been solved。In the first half of 2009, a domestic Dana Hydrochloride Qiqi was approved to treat the clinical research application for the treatment of "severe Alzheimer's disease" to increase indications。

 

   3、Anti -tumor drug: To ensure that tumor patients get safe and effective drugs as soon as possible，Sorafini tablets that meet the conditions of clinical trials，apple acid Schunitinib capsule，Injecting land, Silibin, etc., and several varieties such as Xishebin reduced clinical research，and made clear requirements for research after listing。

 

   4、Anti -A -type H1N1 influenza drug and vaccine: Facing the severe epidemic situation，We will prevent the review and approval of the new type A1N1 influenza drug as the top priority of the work，Timely adjusted the review approval strategy，Take advance intervention、Actively follow -up research production progress、Strengthen communication with the applicant to accelerate the review and approval work，According to the relevant provisions of the State Food and Drug Administration's Drug Special Approval Procedures，Approved a phosphate Oasiwei to improve the production process、Zanamwe inhaled pink fog imports、type A H1N1 influenza vaccine production and listing。