A few days ago，Shanghai Food and Drug Administration issued the "Implementation Plan for the Pilot Work of the Reform of the Reform of the Pharmaceutical License of Drugs"。At present, more than 10 pharmaceutical companies have begun to prepare in the early stage and actively apply for a pilot。Subsequent，Sichuan Food and Drug Administration also arranges to try first，Determined Chengdu High -tech Zone、Wenjiang District, Chengdu、Luzhou Pharmaceutical Industrial Park, including 5 pharmaceutical listing permit holders, holder stake online sports bettingsystem My stake betting apppilot work demonstration area。This means，Following the "Pilot Plan of the Pharmaceutical Located Permits held by the State Council"、Shanghai、Sichuan and other 10 provinces and cities will be included in the pilot，Pharmaceutical listing permits and production licenses & ldquo; double separation & rdquo; policies are officially implemented，Drug research and development and production will no longer & ldquo; bundle & rdquo;。

 

  Specifically，There are three main aspects of the reform of the drug listing license system: First, expansion，Allow drug research and development institutions、Scientific researchers as applicants for drug registration，Submit a drug listing application，After obtaining the drug listing license and the approval number of the drug，Become a licensee to be a drug listing; the second is the foundry，Approve the production of listed drugs，Allows holders to entrust the pilot pharmaceutical manufacturer with qualifications and capabilities in the administrative area; the third is to replace，Applicants or holders have been accepted by the applicant or holder on the pharmaceutical listing permit、Not approved or approved yet，can all submit supplementary applications，Change the applicant、Holders and trusted production enterprises。

 

  & ldquo; The current pharmaceutical registration system in my country is a management mode for stake sports betting applisting stake betting applicenses and production permits，Only drug manufacturers can apply for drug registration，Get the drug approval number。& rdquo; Xu Jinghe, director of the Legal Department of the State Food and Drug Administration, said。With the continuous development of the research and development capabilities of the pharmaceutical industry，The disadvantage of this management method is increasingly prominent。Some manufacturers are pursuing market benefits，Constantly expand the variety of pharmaceutical production or build a new production line，False & ldquo; prosperity & rdquo;。

 

   & ldquo; It takes 10 years for a new drug to go public，Investment exceeds 1 billion yuan，R & D staff pressure mountains。& rdquo; Chen Li, general manager of Huagong Pharmaceutical Technology (Shanghai) Co., Ltd., said，The implementation of the drug listing license holder system will save one -third of the R & D expenses for enterprises，Let some new drugs be available for at least two years in advance。It is understood，Production of a biological medicine，From the construction of the plant to the equipment investment，International standards at about 500 million yuan，If limited resources are scattered in two links in R & D and production，Fund will be very nervous。& ldquo; Outsourcing & rdquo;，Pharmaceutical companies will greatly save fixed asset investment。As of My stake betting appnow，stake betting appShanghai Zhangjiang area has been paired with 3 biomedical companies，Investment in fixed assets in the early stage saved more than 1 billion yuan。

 

  According to the requirements of the pilot，Pharmaceutical research institutions in the future、Personnel can apply for a drug listing permit independently，and can cooperate with qualified enterprises to produce。At the same time，The subjects responsible for the quality of the medicine are also clearer，Once there is a problem with the medicine，Consumers can at the same time to R & D staff、Production enterprise claim。& ldquo; The pilot solution strengthens the main responsibility of the applicant and holder，The interest chain of the interest and safety responsibility of drug quality and safety。This also prompted the applicant to choose to develop、Production、Sales and other partners will be more cautious，To avoid disputes on legal and safety legal liability for drug quality and safety in the future。& rdquo; Yang Yue, an expert from the Senior Training College of the State Food and Drug Administration, said。

 

  In addition，Insufficient utilization rate for some pharmaceutical companies，Questions that cause huge waste，Industry insiders also said，With the gradual landing of the pilot solution，Some pharmaceutical manufacturers will turn off factories with low utilization rates，stake betting appEven stake online sports bettingthe production outsourcing，Eliminate backward production capacity，to avoid waste of production capacity，To maximize the interests of corporate interests。