"Administrative Measures for Registration of Drugs" (Revised Edition) issued a solicitation draft on July 25, 2016。

 

  The scope of applicable to the version 8 years ago was & ldquo; applying for clinical trials of drug clinical trials in the People's Republic of China、Drug production and drug imports，and drug approval、Registration inspection and supervision & rdquo;，"Measures for the Registration of Drugs" (Revised Draft) Solicitation Draft (referred to as & ldquo; revised draft & rdquo;，Same) is defined as & ldquo;，The scope of application is more appropriate to the file name & ldquo; Drug registration management & rdquo;。This means & ldquo; Revised draft & rdquo; Pay more attention to the essence of drug registration management，That is, starting from the functionality of the medicine，Guide drug registration applicants and food and drug regulatory departments in the drug registration process.、Effective and controllable quality。

 

  As a domestic subject or an overseas legal pharmaceutical manufacturer that has the ability to apply for drug registration and be able to assume civil liability in accordance with the law，Drug registration is the most important admission link for drugs to enter my country's market。This time & ldquo; revised draft & rdquo;，The author focuses on the influence of the future of drug establishment and the applicant's response angle.。

 

  1. Drug safety, effectiveness and quality controllers

 

  How should the drug be innovative? Everything is about to return to the manifestation of clinical value，Innovative drugs should have a clear clinical value。Improved new drugs also value clinical value，It should have obvious clinical advantages than the original variety。The pursuit of clinical value of drugs is in the final analysis that is the pursuit of the effectiveness of the drug，And this pursuit not only stays in the stage of registration and listing，& ldquo; Revised stake betting appdraft stake betting app& rdquo; I believe that the applicant obtains the drug listing permit，Research work after the listing should be actively carried out。

 

  In addition，& ldquo; Revised draft & rdquo; also gives Chinese medicine、Natural drug innovation drugs are good，Chinese medicine、Natural Drug Innovation Pharmaceuticals are obtained while listing，You can automatically obtain the protection of Chinese medicine according to the application。Chinese Medicine New Drugs, which obtained the listing license, applied for the protection of Chinese medicine varieties，Stop accepting the listing of the same variety。According to Xianda Data V3.2，The application for the production of new Chinese medicine new drugs from 42 acceptance numbers in 2013，Fall to 15 acceptance numbers in 2015，2016 acceptance number 0，This means Chinese medicine、Domestic research and development passion of natural drug innovation drugs has fallen to the trough。

 

  The requirements of safety are mainly reflected in the verification of the safety of drugs in clinical trials，Follow the safety and rights of protecting subjects。In addition，Listing license system has higher requirements for listing safety，Each year, you need to summarize the changes in the previous annual medicine and the safety information after listing, etc.。

 

  In terms of quality controlling，Prescription technology before and after the listing of drugs、Quality requirements are consistent。& ldquo; Modify the draft & rdquo;，and produce after the first time after listing、Change of changes in quality control and use conditions。This means that the production supervision of drugs becomes tight，The approved products are not just the registration batch pass。but the quality between the batch of each batch of products is controllable。

 

  Links of the material and drug preparations to ensure drug safety、Effective and controllable compromise。Application of the raw and drug application for listing，Application or supplementary application for application or supplementary application for drug preparation，Application for listing without accepting separate raw materials。This will start from the demand side to control the number of bitt of the raw medicine，Avoid unnecessary declarations to avoid excessive repetition of raw materials。

 

  Applying for the listing of drug preparations alone，Research raw materials must have drug registration approval，and must be obtained through legal channels。From this，Regulatory authorities can better manage the source of chemicals source and pharmaceutical manufacturers，Once you find the monopoly or quality problems of the material and drug，You can track the question along the line。

 

  Only the data is true，can be judged whether Stake Sports Bettingthe stake sports betting appmedicine is safe、Effective and controllable quality。Penalties for the registration of false drug registrations and samples increase & ldquo;，For it & ldquo; Revisit the drug approval document，It does not accept its application within 5 years，Putting fines of 10,000 yuan and 30,000 yuan & rdquo;。

 

  To sum up，The risk of drug research and development will allow the enterprise to bear it alone，Enterprises must bear the corresponding quality and R & D risk when they want to obtain the profit of drugs。When the enterprise is projecting,，Should avoid safety and invalid medicines; for the clinical efficacy, innovative projects that are not better than existing drugs，Also give up early to give up。

 

  2、Corporate follow & ldquo; review time limit & rdquo;

 

  & ldquo; Revised draft & rdquo;、On -site inspection time limit and registered inspection time limit requirements，Change to & ldquo; The drug review agency announced to the society at the beginning of each year in the previous year's various drug registration applications、On -site inspection and the statistical report of the progress of drug registration inspection and the time limit for use，and the time limit of the various pharmaceutical registration application technical reviews of this year & rdquo;，That is to say，This time limit depends on the annual budget。

 

  The period of technical review from the "Administrative Measures for the Registration of Drugs" (Trial) to the Order 28 (2007)，Most of the review time limit has been extended，For example, the technical approval of the new drug production is in the trial version，It is scheduled to be completed within 120 days。However, it has been extended to 150 days in the 2007 version of the order.。This time & ldquo; Revised draft & rdquo; No relevant time limit time form，Even the priority review，Nor did the "Opinions on Resolving the Perception of Pharmaceutical Registration Application for the Revolutionary Approval and Approval" mentioned in the review and approval of the review and approval of the review and approval of the review and approval of the review and approval of the review and approval of the review and approval of the review and approval of the review and approval.。

 

  If there is no review time limit，It is difficult to choose correctly when making a project judgment，Enterprises will not be able to evaluate the time cost of the entire project to register the entire project。

 

  3. The status of the registration department is becoming more and more important

 

  In the environment where the cost of pharmaceutical research and development and registration cost is increasing，Domestic subjects or overseas legal pharmaceutical manufacturers will become more and more cautious about the application of drugs。Compliance and risk assessment of drug registration is expected to be more and more dependent on the applicant's ability to understand drug registration regulations and the ability to analyze。

 

  First，The registration department must make a stake sports betting appinitial My stake betting appjudgment on the correctness of the project registration classification。It is worth noting is，During the review and approval of the listing application，Drug registration classification and technical requirements are not changed at home and abroad because of the preparations of the same active ingredients。

 

  Second，The registration department shall make specific suggestions on the project in accordance with the current registered laws and regulations。For example, does the project conform to the general direction of drug innovation that is guided by the country's encouragement & ldquo; guided & rdquo;? Whether it belongs to the medicine that needs to be accelerated in accordance with the law，As a result, it is expected to get priority review and approval? Registered commissioners must also analyze their registration points and risks based on different categories of drug projects。

 

  Last，The registration department often participates in projects that cross -departmental communication。When evaluating the cost of the project，The registered department and the R & D department need to preliminarily design the project research content based on the nature of the project，and evaluate the cost before listing of the overall project，The production department evaluates production costs，Marketing department provides market scale data，Finally estimated the investment feasibility of the entire project。

 

  4、& ldquo; Registered specialist & rdquo;，Comprehensive ability requirements are high

 

  & ldquo; Revised draft & rdquo;。As a representative applicant, responsible for registering and communicating with the food and drug regulatory authorities，Assisting the applicant to carry out the drug specialist developed compliantly，It is a job with very strong comprehensive ability，Need to have corresponding professional knowledge，Also familiar with the law of drug registration、Regulations and technical requirements。

 

  In view of Chinese medicine and natural medicine、Chemical Drugs、Clinical trial applications such as biological products、Listing application、Application materials and requirements for supplementary applications，Pharmaceutical registration subsequent clinical trial plan and major changes、Refining application after clinical trials are suspended、Regular evaluation reports and information submitted by the annual report，and biological equivalent test、The filing regulations and requirements of the instructions and labels belong to the formation part of the formation，Registration specialist also needs to clarify the interconnected and differences between increasingly complicated regulatory documents。

 

  From the perspective of the labor cost and stake sports betting appmanagement stake betting appof the company，Registration specialist selected by the company，It is more likely that the company's original person who is responsible for registered as concurrently served。But，& ldquo; Revised draft & rdquo; registered commissioner's ability required，far higher than the general level of the existing registered personnel，& ldquo; Revised draft & rdquo; The responsibility of the registration commissioner required by the company is higher than the company's current authorization，So，Enterprises will change the change of laws and regulations through modifying job duties and related processes。

 

  According to & ldquo; revised draft & rdquo;，Food and Drug Regulatory Department Establish a bad behavior record for applicants and registered commissioners who submitted false information and samples，and announced。Registered commissioner is considered by career，will choose a large -compliant company，This will further accelerate the survival of the fittest。Many of the problems were exposed in GMP flight inspection, which were reports of internal personnel，Therefore, how to manage the registered commissioner is also required by the enterprise。