1、What is the positive significance of the pilot system of the Pharmaceutical Listing License held?

 

  The stake sports betting appstake betting appholder system of the drug listing license is Europe、The United States、Pharmaceuticals such as Japan and other developed countries and regions in the field of pharmaceutical supervision，This system adopts the management mode of the separation of drug listing permits to the separation of production permits，Allowing the holder of the drug listing license (holder of the drug listing license certificate，That is a pharmaceutical manufacturer、R & D institution or scientific researcher) Self -producing drugs，or entrust other manufacturers to produce drugs。

 

  Current，The management model of implementing listing licenses and production licenses in my country，Only allowing drug manufacturers to obtain the drug approval number，After certification by the quality management of drug production，Fang can produce this medicine。In practice，Drug research and development institutions and researchers cannot obtain the drug approval number，New drug research and development institutions can only transfer relevant drug technology to drug production enterprises after obtaining the new drug certificate。This drug registration and production license & ldquo; binding & rdquo; mode，Not conducive to encouraging innovation，Is not conducive to ensuring drug supply，Is not conducive to suppressing low -level duplicate construction。Piloting the pilot work of the holder system of the pharmaceutical listing permit，For encouragement of drug innovation、It is important to improve the quality of medicines。

 

  August 2015，The State Council issued the "Opinions on Reforming the Approval Stake Sports Bettingstake online sports bettingSystem for Reforming Drugs Medical Devices" (Guofa [2015] No. 44，Documents No. 44 of the State Council)，Pilot the pilot of the holder system for listing permits。Carry out pilot work，It is conducive to drug research and development institutions and researchers actively creating new drugs; conducive to industrial structure adjustment and resource optimization allocation，Promote professional division of labor，Improve industrial concentration，Avoid repeated investment and construction。

 

  2. The legal basis for pilot work?

 

  November 4, 2015，The Seventeenth Meeting of the Standing Committee of the Twelfth National People's Congress review and approve the "Decision on the Pilot and Related Issues of the State Council to carry out the Pharmaceutical Located Pharmaceutical Ownership System" (hereinafter referred to as "Decision")，Authorized the State Council to carry out the pilot of the holder of the drug listing license holder，Allowing drug research and development institutions and researchers to obtain the drug approval number，Affordable to the quality of drugs。

 

  3、What is the area range of the pilot area，How to determine it?

 

  The pilot area is Beijing、Tianjin、Hebei、Fujian、Shandong、Zhejiang、Fujian、Shandong、Guangdong、Ten provinces in Sichuan、Municipality directly under the Central Government。The relevant provisions authorized by specific matters based on the newly revised "Legislative Law"，The pilot of the stake sports betting appstake betting appholder system of the drug listing permit shall be limited to in some areas。Careful research，Comprehensive consideration of the distribution of the development of the pharmaceutical industry、Free Trade Pilot Zone、Beijing -Tianjin -Hebei coordinated development and the number of Chinese drug registration applications in the past three years，Form the pilot area as the above ten provinces、Municipality directly under the Central Government。

 

  4. How is the scope of pilot drugs stipulated?

 

  The scope of the pilot drug mainly includes new drugs approved after the implementation of the pilot solution、Some medicines approved by the new standards and some medicines that have been approved before the implementation of the pilot plan。excluding anesthesia drugs、Psychiatric drugs、Medical toxic drugs、radioactive medicine、Prevention of biological products、Blood Products。

 

  5、How is the implementation period of the "Pilot Plan for the Pharmaceutical License of the Pharmaceutical Listing Permit"?

 

  "Pilot Plan for the Pharmaceutical License of the Pharmaceutical Listing License" (hereinafter referred to as the "Pilot Plan")，Implementing to November 4, 2018。

 

  6、What is the main difference between the pilot of the stake sports betting appstake betting appholder system of the drug listing license and the current management system?

 

  Carry out the pilot of the holder system for listing permit，The most important difference between the current management system is，Allow R & D institutions and researchers to hold drug approval number，Becoming a Pharmaceutical License held by holder，and the safety of the drug、Effective and controllability of quality and controllability with comprehensive responsibility。

 

  Seven、What are the requirements for the holders of the drug listing license?

 

  Drug listing permit The holder shall be a drug research and development institution that can be established in the pilot area and can be responsible independently，or scientific researchers who work in the pilot area and have Chinese nationality。Pharmaceutical manufacturers in the pilot administrative area shall be implemented with reference to the relevant regulations of the holder in the Pilot Plan。

 

  eight、What are the obligations and responsibilities of drug listing permits?

 

  Performing the "Pharmaceutical Management Law of the People's Republic of China" (hereinafter referred to as the "Drug Management Law") and other relevant drug registration applicants、Drug production enterprises register for drug development、Production、circulation、Corresponding obligations in monitoring and evaluation，and bear the corresponding legal liability，Specifically includes signing a written contract and quality agreement with the trustee manufacturer、In accordance with the requirements of relevant national drug circulation laws and regulations, etc., or other enterprises that comply with qualification requirements to sell drugs、Establish a website to actively disclose drug information、Compensation obligations that perform the public damage caused by the performance of the listing drugs。

 

  Nine、What are the requirements for entrusted production enterprises of actual production drugs?

 

  The trustees of actual production drugs shall be established in accordance with the law in the pilot area，"Drug Production License" holding the corresponding scope of drug production and the "Specifications for the Management of Drug Production Quality" (hereinafter referred to as the drug GMP) of the drug production enterprise。

 

  10. What are the obligations and responsibilities of the trustees?

 

  The entrusted production enterprise shall fulfill the obligations of the drug production enterprise stipulated in the "Drug Management Law" and other regulations，and bear the corresponding legal liability。In addition，It should also fulfill the relevant obligations agreed with the holder，and bear the corresponding legal liability。

 

  eleven、Trusted production Stake Sports Bettingenterprises cross -testing points stake betting appof the provincial (city) administrative area，How does the provincial drug supervision and management department where the holder is located to carry out supervision?

 

  The provincial drug supervision and management department where the holder is located is responsible for the supervision and management of holders and approval of listing drugs，Supervise holders guarantee product quality、Entrusted production management、Listing sales and service、Dispined reaction monitoring、Product Recall、Obligations and other obligations after listing and other obligations will be supervised and managed。Trust -production enterprises across trial points of the provincial and municipal administrative area，The provincial pharmaceutical supervision and management department where the holder is located jointly the provincial pharmaceutical supervision and management department where the trustee is located for extension supervision，Supervisor Listing License held by holders to perform responsibilities、Responsibility implementation，Urgent strict management of trusted production enterprises、Standardized production。The provincial regulatory department where the entrusted production enterprise is located is responsible for the daily supervision of related enterprises，Urges relevant companies to continue compliance。The provincial pharmaceutical supervision and management department of the holder and the provincial pharmaceutical supervision and management department where the trustee is located to strengthen the connection and cooperation，Tongli collaboration，Ensure that regulatory tasks are implemented in place。

 

  Twelve、What are the specific requirements for the investigation and punishment of pilot drugs?

 

  The holders and trustee manufacturers who violate the laws and regulations such as the "Drug Management Law" and the relevant provisions of the "Pilot Plan"，The provincial drug supervision and management department of the local area shall organize the investigation and punishment in accordance with the law。

 

  The hidden safety hazards caused by the quality and safety of drugs，Provincial drug supervision and management department shall take emergency risk control measures on related products，and organize the case to investigate and deal with it in accordance with the law，Hold the responsibility of the holder and the person directly responsible。

 

  Illegal behavior of drug production links，The provincial pharmaceutical supervision and management department where the holder is located organizes the responsibility of the holder (or the trustee)。

 

  Thirteen、What is the effectiveness of the drug approval number issued during the pilot work?

 

  Pharmaceutical approval number issued during the pilot work，After the pilot period expires，Continue to be valid during the validity period of the certification document of the drug approval。

 

  14、After the pilot work Stake Sports Bettingis stake online sports bettingover，What are the corresponding work measures?

 

  After the pilot work is over，Food and Drug Administration will summarize the pilot experience in time，For practices proved to practice，Timely proposes to modify and improve the laws of the "Drug Management Law" and "Regulations on the Implementation of the Drug Management Law"、Suggestions of regulations，and modify and improve relevant departments regulations，To fully implement the pharmaceutical listing license holder system for all drug varieties in a timely manner。