CFDA recently issued the "Announcement on Carrying out the check -up work of drug production technology (draft for comments)" (hereinafter referred to as "Announcement")，Public comments from the society，Regardless of import or domestic，Chinese medicine、Chemical medicine、Biopharmaceutical，Self -examination of the production process of 160,000 drug approvals，It is undoubtedly from & ldquo; Consistency of the production process and registration process & rdquo;，Pharmaceutical companies faced once again with integrity torture。

 

  A large number of batches may be eliminated

 

  The first edition of the "Administrative Measures for the Registration of Drugs"，Pharmaceutical R & D registration management is extensive，The lack of protection awareness of the technical data of the enterprise，Some key production process technology leaked in the application process，Forced stake sports betting appstake sports betting appenterprises to deliberately hidden key technical content when submitting the application information，or modify the prescription、Craft、Parameters，To prevent core technology leak。

 

  Of course，The situation of the company's intentional fraud is also not to be ignored。The first edition of the "Administrative Measures for the Registration of Drugs" was implemented in 2002，The supervision power is still weak，Some enterprises in order，A large number of drug R & D units falsify，Transfer the work pressure of enlarging the process of commercial production to the manufacturer。

 

  The new version of the "Administrative Measures for the Registration of Drugs" is added to the new requirements of the production site inspection，But individual companies continue & ldquo; take shortcut & rdquo; research and development inertia，Significantly reduce R & D costs。An industry insider who has been engaged in drug research and development for a long time told the "Medical Economic News" reporter: & ldquo;，In fact, the company does not produce samples by itself，I just bought the original research sample to cope with on -site inspections。If industrial enterprises buy such a approval，Obviously unable to produce according to the registration process。& rdquo;

 

  Chen Qinghua from Guangzhou Haibote Pharmaceutical Technology Co., Ltd. has long been engaged in results transfer，She thinks，Whether there is any production process self -check -in, right，The production process is a key point that the buyer values ​​very much in the process of transfers。& ldquo; according to whether the registered production process route can make a qualified sample，It is necessary to focus on itself。If you buy the approval or results，Weighing the registered process and actual production process, there is no way stake betting appstake sports betting appto restore，Whether this approval still has market value needs to be cautious。& rdquo;

 

  & ldquo; 160,000 drug approval，Many approach of the original registration process is likely to be unlocked，Especially before a large number of landmarks transferred to the national standard。& rdquo;，& ldquo; Just as consistent evaluation，It is impossible for enterprises to do all the varieties，Must screen。Self -inspection of the company's production process also needs to sort out varieties，After comprehensively reviewing the value of the approval，Give up some，A large amount of accumulated pressure drugs are gradually eliminated, which is also in line with industrial upgrading、The spiritual reform spirit of eliminating backward production capacity。& rdquo;

 

  Approval of the market pressure

 

  Production process self -examination is essentially a question of corporate integrity，Because the enterprise declares the registration or filing of the regulatory department，No follow in actual production，and may not have a timely or intentional application or filing for changes to the production process。Some of the shortcomings existing in the previous check -up site inspection，It will also change with the new situation of regulatory situation from & ldquo; beforehand of supervision & rdquo; gradually transition to & ldquo; full process supervision & rdquo;。

 

  Chen Qinghua further said: & ldquo; Under the new policy situation，Upgrade with the regulatory environment，Enterprise will gradually calm down in terms of investment varieties，Some clinical and registered varieties are really not as easy to sell as in the past。More jobs that the company needs to do after getting the approval，Supervision pressure is also greater，It is bound to consider cost investment My stake betting appstake sports betting appand market conditions，Therefore, it will be more cautious in introducing varieties。& rdquo;

 

  Most pharmaceutical companies exist in process changes，Impact is large and small。Many companies do not deliberately produce inferior products，Instead, the pressure and cost control of the bidding price reduction。Enterprises also hope to not affect the quality of medicine、efficacy、Under the premise of security，By optimizing process，Improve production efficiency。

 

  Xie Mingyan, general manager of Guangzhou Guojian Medical Consulting Service Company, admits: & ldquo; Production enterprise is not willing to apply for process change，Instead, you have to wait 2 to 3 years in the past to apply for a process change，The production line can only be vacant，Time cost is too high。Recommended policy supporting，Rapid approval to enterprises that take the initiative to apply for the process。& rdquo;

 

  Dested，The Announcement has already improved the process of changing the process. Application for accelerated approval: the provincial food and drug supervision department will send the application information to the drug review center within 5 days after acceptance; Review，If necessary, you can ask the applicant to supplement the information，The required time is not included in the time limit of the technical review; the State Food and Drug Administration should complete administrative approval within 5 days。

 

  Opportunities under the pressure of compliance，Under the policy background of the drug listing license holder (MAH)，High -quality drug approval may not be transferred as in the past。Xie Mingyan said: & ldquo; The past pharmaceutical process in my country is relatively low。Take generic drugs as an example，In the past, we were imitation My stake betting appMy stake betting appstandards，How to produce the original medicine，The prescription process we have not improved。In the future, with industrial transformation and upgrading，Professional talents engaged in prescription process research have received greater attention，Enterprises that are truly committed to the research and improvement of pharmaceutical technology will also enjoy policy dividends，It will inevitably get a higher -quality commissioned production opportunity。& rdquo;