Party Central Committee、The State Council attaches great importance to drug safety supervision，In recent years, a series of major reform measures have been launched，Dedicated to improve the unified and authoritative food and drug safety regulatory agency，Establish the most stringent regulatory system for the entire process，Deepening the Reform of the Approval System of Drug Review，Improve the level of drug quality and safety，Promote the sustainable and healthy development of the pharmaceutical industry，Laying a solid foundation to ensure and promote public health。These reform measures，In the final analysis, drug supervision is required to follow the law、Drug research and development and production is more scientific。Food and Drug Supervision Department must implement the central decision -making deployment，Continuously improve the level of scientific supervision，Strive to ensure the safety of drugs and effective。

 

  Ensuring safety and effectiveness is the core essential of drug science supervision

 

  Drugs are special products for disease prevention and disease，Must ensure safety and have exact effects。Whether it is a producer or a regulator，Nothing can forget to ensure that the safety of drug safety is effective。In order to ensure the safety of drugs and effective，Drug supervision has made a series of strict regulations on the listing of new drugs。For example，A drug application and launching clinical trials，First of all, it is necessary to confirm the chemical structure of the drug; secondly, test on animals，stake betting appstake online sports bettingResearch's metabolic process of drugs in animals、Action target and effect; we must perform again Ⅰ again、Ⅱ、Phase III clinical trial，Confirmation of its safety and effectiveness。Then，can the laboratory products be converted into industrial products，Establishing drug quality control standards，Make sure the quality of the drug is stable and controllable。During the development of medicine，Drug safety Effective is the basic premise。Meet this basic premise，It must rely on solid scientific research、Reliable clinical trials、Effective supervision and management。The entire drug research and development process must adhere to the scientific and rigorous attitude，There must be no false fake; regulators must strictly review and inspect with a highly responsible attitude towards life，Can't have a little bit of tiger。

 

  Strict follow -up specification is the basic requirements of drug science supervision

 

  Drugs have become the strictest products in the supervision of governments due to their particularity，Research and development、Production、circulation、Use strict specifications in each link。Drug clinical trials require that each data must be truthful、Timely record，Make sure the data is complete、can be traced back。If this data has problems，It will not only bring hidden dangers to the safety of the masses，It will also seriously affect the healthy development of the pharmaceutical industry。So，For data counterfeit problems，The attitude that must be & ldquo; zero tolerance & rdquo;，Strictly follow the provisions of the Drug Management Law，Punishment and accountability of relevant institutions and responsible persons。Drug production process must comply with GMP specifications (production quality management specifications)，Make sure that quality control continues compliance。For this，You need to further improve the regulatory system，Construction of a professional chemical inspector team that is compatible with the innovation and development of my country's pharmaceutical industry，Strict on -site inspection，Strict investigation and punishment of illegal violations，Purifying the industry ecological environment，Promote the formation of advocating science、Respect science、Conscience to do medicine、Social atmosphere of abide by the law，Effectively guarantee the safety of the masses for medication。

 

  Consistency evaluation Stake Sports BettingMy stake betting appof generic drugs is an inevitable choice for drug science supervision

 

  New medicine must & ldquo; New & rdquo;，Imitation drugs must & ldquo; same & rdquo;。This requirement can be replaced with the original research drugs in clinical practice，Imitation drugs that cannot reach the quality and efficacy of the original drug cannot be approved for listing。my country's generic drugs enter the 21st century before being approved by the country，Limited to the conditions at that time，Approval standards according to national standards，No comparison with the original medicine。2012 State Council issued "National Drug Safety & LDQUO; Twelve Five -Year Plan"，Mission to propose the consistency evaluation of generic drugs。2015 The State Council issued the "Opinions on Reforming the Approval System of Reform of the Medical Devices for Medical Device"，Reconstruction of the requirements for the consistency evaluation of generic drugs。February this year，The General Office of the State Council also issued a special post，Specific deployment of the consistency evaluation of generic drugs。Promote the consistency evaluation of generic drugs，It is a major progress in the scientific supervision of drugs in my country，For the improvement of the development quality and international competitiveness of my country's pharmaceutical industry、Reduce the burden of social medical expenses、It is very important to promote healthy Chinese construction。This is a lesson for history，This kind of supplementary lesson United States、Japan and other countries have experienced。

 

  Reform drug review approval system is to promote drug supervision more scientific

 

  According to the Party Central Committee、requirements of the State Council，We launched a series of reform measures in drug supervision: simplifying the approval procedures for clinical trials of new drugs，Postermodel management of clinical trials of generic drugs，Conducting drug clinical trial data self -examination inspection，Accelerate the approval of the market urgently need medicine。These measures have reduced the quantity of the accumulation of drug reviews。Although the reform has achieved results，But there is still a large gap compared with the expectations of the enterprise and the requirements of industrial innovation development。We will further speed up the pace of reform of the drug review approval system，Reconstruction of the drug technology review system。1 is to highlight clinical lead。Judges with clinical medical stake sports betting appbackground and experience stake betting appas the team leader，Organization Pharmacy、Toxicology、Statistics experts conduct collective reviews。Second, the implementation of the project administrator system。Organization and coordination of the administrator is responsible for applying for project review，Let the reviewers focus on the technical review，Reduce transactional work interference。Third, establish a conference communication system for the review team and the applicant。Important nodes in clinical trials，Communicate and discuss the important matters in the review by the reviewer and the applicant，Improve review efficiency。Fourth, the establishment of an expert consulting committee system。For some major technical issues and major differences in both parties，Publicly demonstrated by the Expert Consultation Committee，Put forward opinions for decision -making reference。Five is the establishment of review and approval information disclosure system。Standards for drug review and approval、Program、Disclosure to the society，Accept social supervision。Create these systems，It will allow us to take a big step on the scientific road of drug supervision。

 

  Enhancing service awareness is an important manifestation of drug science supervision

 

  For the regulatory authorities，Enterprise is both supervisory object，It is also a service object。With the in -depth implementation of the innovation -driven development strategy and the steady advancement of supply -side structural reforms，The R & D production capacity of Chinese pharmaceutical companies has increased significantly。This higher requirements for drug science supervision。We must adhere to the supervision in the service，Further innovative drug review mechanism，Optimized review process。First, the guidance specifications are first。Accelerate the formulation and improvement of technical guidelines for drug review，On the one hand for corporate drug research and development reference，Let the enterprise take less detours;，Unified reviewers and corporate drug R & D personnel。The second is to communicate in China。Strengthen the exchange between reviewers and corporate R & D personnel，Make a meeting at an important point，You can also arrange temporary meetings according to the proposal of the enterprise or reviewer。Reviewers should learn new medicine knowledge，A study with an enterprise stake betting appsolve the problem in the Stake Sports Bettingreview of new drugs。Third is to make the approval decision after。As long as you are doing a good job of guidance、Consensus based on communication、Decisions made，You can get understanding and support。

 

  No matter what job，Respecting science is a big premise。Current，Innovation of the pharmaceutical industry innovation driver development is in the ascendant，The people of the people are getting higher and higher for the effectiveness of ensuring drug safety。Enterprises must implement the main responsibility，Strictly control the product quality and safety，Let the people share the benefits brought by scientific and technological innovation to human health。Food and Drug Supervision Department must seize the opportunity、Make the difficulties and go up，Earnestly implement the decision -making deployment of the Party Central Committee with Comrade Xi Jinping as the core，persistently promoting the reform of the drug review and approval system and the reform of the drug circulation system，Constantly improving the scientific level of supervision，To promote national health、Comprehensively well -offly made a contribution。