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2016,This policy is the best policy,No one!
Release time: 2016-07-13 & nbsp & nbsp & nbsp Source: Anonymous
  The country takes the lead in the MAH pilot in ten provinces and cities,80%of new drug applications in recent years are concentrated in large enterprises and emerging companies operating with dual new models of commissioning and agency sales,Product listing license and production license authorization will no longer be bundled,Product R & D actual investor scientific research achievement property rights are effectively protected,Allowing self -selection entrusted processing enterprise,No need to build a production enterprise from scratch in order to ensure the ownership of the product,Passes various tedious certifications。
 
  This not only greatly saves the investment cost of hardware such as factory and production lines,Effective integration and improvement of industry production facilities and capacity utilization,Avoid repeated investment,inefficient operation,At the same time, it also effectively accelerates the transformation cycle of scientific research results,Policy loosening is to protect the property rights of scientific research results,Encourage industry innovation to bring a good head。
 
  stake sports betting stake betting appappThe holder needs to have the risk to bear ability
 
  But on the other hand,After the listing license is separated from the production permit,If the background of the listing licensee is not restrained and required,Drugs are special products directly used in the human body,Once serious quality and safety problems occur,Whether the safety of the product is indeed guaranteed and controllable.。The reason why my country's original drug approval system requires that only manufacturers are qualified to obtain drug approval.,Once quality risk occurs,Compulsory requires enterprises to bear and fulfill their responsibilities。
 
  If it is an individual or research and development unit,Both do not have the production and operation and sales capabilities of the entire industrial chain of the drug,Not to have enough risk bearing and compensation capabilities。Relying on insurance or guarantee,It seems too far away and deviates from the national conditions,At least far water does not solve the thirst。Drugs to stop medicine for severe adverse reactions,Death of the heavy person,Enterprise is out of home,Product suspension,Factory shutdown。The permission system can only let go of the institution with corresponding responsibility capabilities,Avoid risk accidents。
 
  It is recommended that the state should define the status of the listing permit,Be sure to bear the performance of drug safety responsibility。In addition,The pilot solution only mentioned that the identity of the listing licensee is a scientific research unit,Scientific researchers and manufacturers,Actually, a considerable number of product batch scientific research units have already transferred to marketing institutions or manufacturers,Those manufacturers that do not have their own,Grasp new products in one hand,Emerging enterprises that grab new products sold in one hand are the biggest beneficiary and the largest investment group of the MAH system,It should also be clearly stake sports betting appstake betting appincluded in the list of listing permit holders,It is reflected and protected to the latter's products and scientific research investment rights。and the consistency evaluation and clinical trial for investment,Whether individuals and R & D institutions have enough financial resources to bear the same question mark。
 
  Quality and Safety Guarantee needs to be deepened and refined
 
  Some countries are required to submit regular product safety reports for products during the monitoring period of new drugs,It is recommended that this policy country is best to classify and manage on the product category,Gradually transition to implementation,Monitoring period for new drugs,The product is verified and ensured that the product is tried first,New products during the monitoring period and some products with higher risk control requirements will not be implemented for a while。Compared to the property right protection problem of property owners,The lives and health of the people should be topped。
 
  The division and recovery subject of product quality problems should also be further clarified,Avoid manufacturing enterprises and listing permits to kick the ball with each other。Natural disasters and man -made disasters,How to define the technical and technical and technical problems of the holder of the listing permit,Or the production responsibility of the manufacturer? If it is not the responsibility of the manufacturer,While investigating the responsibility of the holder of the listing permit,Should it be held accountable for the release department of the drug approval?
 
  More focus and controversy
 
  For how to avoid commissioned processing enterprises, I cleverly obtain a listing license to hold the technical information of the holding person to declare itself,It is as good as the drug approval of some manufacturers to invade the commissioner in the past。80%of some enterprises from the commission processing,The past in the product property right My stake betting appis stake online sports bettingnot very clear,Sheep into the wolf mouth,Once became the target of the production enterprise and the capital market, and the pair of dates、Model play of the knife and tongue battle。
 
  Reporting the scientific research unit through different systems and names,How to ensure the sole transfer right of the product transferee,Avoid that a daughter of scientific research units marry more,Multi -party profit,Either the rights and interests of the transferee,Policy implementation refinement also needs to be considered。
 
  There is also a climax in the drama,How to perform pilot operations in the report and the approved products,Let those high -quality products and heavy products that send them in the production enterprise return to their personal parents,Is the manufacturer willing to release,Can it be Tanci,Wait and see。Whether many familiar brands are familiar with the public will change the manufacturer,Whether the biological mother and adoptive mother will wipe the gun to fire for their children,The story of the market watch while walking。
 
  Another dispute after the implementation of the new policy is,After implementing the listing license system of past products,By changing the manufacturer,Can a raccoon cat change prince,Avoid previous low -priced records,Fan decoration a new,Come again。Notice for product quality for some problems in the past,Whether there is a problem with whitewashing。
 
  Listing license holder system is a long -lost spring rain for the pharmaceutical market,It is also a consolation warm sun and good news that gives a series of unprecedented strict governance institutions and manufacturers,It is worthy of great praise。Divide in various policies for rigor、Professional、Clear and systematic,Balanced and perfect as possible,Avoid taking care of each other。
 
  The country can allow individuals to hold drug approval,Brotting all the risks and quality and safety responsibilities; stake sports betting appstake online sports bettingallowing the processing method through commissioning processing method,No longer required everyone to build factories,Caused the repetitive construction of social resources and great waste,On the basis of improving the benefits of clear property rights,How to truly promote and improve corporate marketing and operation,Unlock the various leg tie and load sandbags of the development of new drugs,To make the scientific and technological achievements of drug development to better realize market conversion,Serving the public is particularly key。
 
  With innovative soil and supporting policy support,The spring of medical innovation can really come。