Recently，Reporters at & ldquo; Seminar and key issues of drug management law practice and key issues & rdquo;，After the State Council issued the reform of the examination and approval system of pharmaceutical medical equipment last year,，Many reform experiences need to be solidified by legislation。Where，The revision of My stake betting appthe stake online sports betting"Drug Management Law" is progressing rapidly，At present, the third draft has been formed，Recently will further demonstrate、Modify，Then solicit opinions widely for society，strive to send the revised draft as soon as possible to the review of the draft。

 

  Professor Wang Chenguang of Tsinghua University pointed out，stake online sports betting"Drug Management Law"、Production、Basic laws that circulate and use。It was implemented since 1985、After the revision in 2001，It does play an important role，but still traces of the planned economy。Especially since the new century, my country's pharmaceutical industry has entered a fast development stage，This method compares with the requirements of improving government governance methods and capabilities，Compared with the globalization and high -tech development requirements in the field of drugs，Still distance。

 

  He thinks，After the revision, My stake betting appthe stake online sports betting"Drug Management Law" should have four major functions: first，Create the common legal foundation and system maintenance of all participating subjects in the field of drugs，Give full play to the quality of drugs、The fundamental function of maintaining the legitimate rights and interests of citizens' medication; second，Reasonably determine the relationship between the government and the market in the field of drugs; third，Determine the status of all subjects in the drug field，Coordinate its interests，Standardize its behavior; fourth，Innovative regulatory concepts and systems，Promote the modernization of my country's drug safety governance system and ability。

 

  Safety Cooperation and Communist Governance

 

  2015 Global Pharmaceutical Market share distribution diagram，North America accounts for 48.7%，Europe accounts for 22.2%，Japan accounts for 8.1%，Latin America accounts for 4%，Africa、Asia and Australia accounted for 16.6%。From the perspective of drug innovation distribution of various countries，The United States ranked in the first echelon、EU，The second echelon is Japan，China has jumped to the third echelon，This is enough to reflect my country's rapid progress in drug innovation。

 

  Professor Shao Rong, a professor at the University of Pharmacy，During the formulation of the Drug Management Law，Be sure to remember that the pharmaceutical supervision department is the main law enforcement department of drug management，but not the only law enforcement department。The purpose of this law should be the national organs、All ministries and commissions collaborate，All for drug safety supervision、For the health of the public、For the development of the pharmaceutical industry。At the same time，We also need to solve the problem of the division of the right to the drug supervision system，Provincial and local、Provincial and local，Especially system reform two -in -one、After one after one，Be sure to take into account the stability of the law。

 

  Xi'an Yangsen Pharmaceutical Co., Ltd. government affairs and market access senior director Chen Jian admitted，stake sports betting appPharmaceutical My stake betting appcompanies are generally a heavy investment industry，It requires a stable predictable positive incentive environment，Multiple policy integration will lead to too many uncertain factors in this environment，thus affecting the rapid development of the entire industry。For example，Currently in & ldquo; Three Medical & RDQUO; The five major categories of policies faced by pharmaceutical companies in the reform are all moving，Including listing access、Bidding purchase、Product pricing、Medical insurance reimbursement, etc.，But the gratifying is，Most policy changes are marching towards the direction of incentive。

 

  Wang Chenguang pointed out，The revision of the Drug Management Law should have an institutional innovation orientation、Globalization vision and strategic vision、top -level design、Opening the door legislation and scientific legislation。First, it is necessary to jump out of the limitation of departmental interests and industrial interests，Not only the competent authority and manufacturer; the second is to jump out of simple & ldquo; supervision and supervision & rdquo; binary pattern，Introduction to the government -led、Industry self -discipline、Diversity participation、The new type of supervision system of social co -governance; the third is the limitation of jumping out of the region and national boundaries，It has a global vision; the fourth is the limit of jumping out of the pharmaceutical industry，Consider it with other systems (Health China、Social governance system、rule of law, etc.) coordinated supporting facilities，With global concept。

 

  Take into account the use link

 

  Some experts proposed，The current stake online sports betting"Drug Management Law" has less supervision of the use link，But 80%of medicines are sold in the hospital market，The newly revised "Drug Management Law" should appropriately increase the terms，Follow the lack of supervision in use。Chen Jian recognized，From the perspective of foreign experience，Drug supervision should be a department management to the end，Including use in the hospital，This can ensure the independence stake online sports bettingand stake sports betting appunity of the regulatory agency。

 

  The reporter learned，Questions that extend My stake betting appthe stake online sports betting"Drug Management Law" to the use link，Most experts in the industry are agreed。Some people in the industry have proposed，Administrative licenses should implement supervision，and the pharmacy department of the medical institution is also a unit for sales of drugs，We can turn the current business license management into a pharmaceutical sales license management，Incorporate the pharmacy of the medical institution into the scope of the administrative license of the sales license。

 

  will be on，也Some experts proposed，Although the number of research compounds in my country has increased rapidly，But most of them are gradual innovation，New drugs on the market are almost recognized by developed countries。Data displayed by the Foresight Data Research Institute，In 2015, the world's innovative pharmaceutical market is nearly 600 billion US dollars，Among them, the Chinese market accounts for less than $ 10 billion。The sales of 19 innovative products approved in China for the first time in China are less than $ 500 million，The sales of these products all come from the Chinese market。

 

  Chen Jian recognized，stake online sports betting"Drug Management Law" shall be managed in accordance with the drug life cycle，Can promote innovation more，Guarantee quality，Follow the basic laws of the medicine，Easy to be reasonable for supervision procedures、Clear、Transparent、Consistent，and ensure that each link is connected to each other，Fully guarantee the safety of the medicine、Effectability and quality controllability，Guarantee the availability of the patient's medication。Calibility should include three aspects: the early obtaining of innovative drugs、The quality assurance of generic drugs and sustainable supply chain and the use of supply chain，To reflect the country's basic positioning of drug management。

 

  In terms of production，Wang Yue, deputy director of the Food and Drug Administration of Jiangsu Province，Modify the listing license system，Establish a listing license system on the basis of summing up the pilot experience，Clarify the responsibility stake sports betting appof stake sports betting appthe production enterprise in response to the production process，Listing licensee's safety of medicines、Effectiveness and quality controlled responsibility，Quality problems can be recovered with the production enterprise in accordance with the contract of the production enterprise。

 

  At the same time，Implementation of the No. 1 Lifeline System that is compatible with the listing license system，The approval number of the listing license is not due to continuing application、Change the application and change。Drugs after listing，Approved Drug Registration and Approval Validity to continue，can be controlled according to its risk control，Approve its continuation period，The duration period is at least 5 years。For non -high -risk drugs，Continuing endlessly。Continuing the application for approval during the approval period，can continue to perform drug production and import。The approval number of the drug after continuing is unchanged。