It has ended in the first half。For the pharmaceutical research and development industry，This half of the year is a more frequent year of policy introduction。One after another policy release，Is a challenge and opportunity。Self -check check、Chemistry registration、The listing license system is the three major policies in the first half of the year，and the approval is difficult to get、Registration application is less、New changes in technical transfer are three key points。

 

  1. From clinical verification to craft verification?

 

  July 22, 2015，CFDA's announcement on self -examination of clinical trial data of drugs，A total of 1622 drug acceptance numbers。This is just a beginning，In the first half of 2016，The withdrawal announcement of related drugs is still issued one after another。As of June 2016，A total of 317 acceptance numbers that the company actively withdraws through self -inspection during the CFDA specified date，Application for reduction of clinical trials, etc. No registration applications need to be submitted at 193，Announcement does not approve 40，Announcement withdrew 876，CFDA database has listed product approval number 17。

 

  2016，In order to promote the application for import registration related applications as soon as possible，CFDA releases two big moves。

 

  1 is to promote long -term unpacking of drug registration inspection reports and related information、Samples and drug registrations related to standard substances make up for information as soon as possible。that is, "Announcement of the General Administration on Drug Registration Inspection (No. 36, 2016)"，The announcement was released on February 5，CFDA has no further information disclosure。

 

  Second, the on -site verification process。According to the "General Administration of the General Administration My stake betting appstake online sports bettingof Printing the Pharmaceutical Clinical Test Data Checkup (Interim) Notice (Interim) (Food and Drug Administrative Pharmaceutical [2016] No. 34)，CFDA Food and Drug Review and Inspection Center will announce the on -site inspection plan to publicize 10 working days on its website，Drug registration applicants have not submitted the withdrawal application within 10 working days after their publicity.。After the online publicity period is over，For varieties that have not been submitted for withdrawal，The Inspection Center will notify the drug registered applicant、Clinical trial institutions and its local provincial food and drug regulatory department on -site inspection date，No application for the withdrawal of the applicant of the drug registered applicant。

 

  April 1, 2016，Announcement of the General Administration of the General Administration on the Application of the Application for the Application of the Data Review of the Drug Clinical Test (No. 81, 2016) decided that the 256 newly received clinical trial application or imported by the 256 newly received after the announcement will be announced after the announcement Drug registration application，Except 75 registered applications that the applicant for the registered drug registered applicant has taken the initiative to withdraw，Check the clinical trial data of drug clinical trials one by one for the remaining 181 registration applications。June 13, 2016，"Announcement on the Reporting System of Reporting Self -Reporting Reporting System on Opening Drug Clinical Test Data"，Requires announcement of 181 drugs on the 81st 2016, reporting the clinical trial data self -examination report of the drug clinical trial data from June 13th to 27th。

 

  Comments

 

  This means that clinical self -examination verification is about to enter the process，Future drug declaration after production and registration，Anyone who has a clinical trial must submit a self -examination report，Accept clinical verification。I think，Self -examination of clinical trial processing process will promote the success probability of the effectiveness and safety of clinical trials when the drug is established，Products with clear clinical efficacy will be more favored。

 

  It is reported，CFDA intends to check stake sports betting appthe production process，It is mainly aimed at the inconsistency of the actual production process is inconsistent with the approval production process，and drug safety、Products that are affected by validity。CFDA will take this opportunity to standardize the supplementary application process of process changes，This is also conducive to enterprises to propose process changes according to the actual situation in consistency evaluation research。

 

  From 2007 and 2010 CFDA, the experience of verifying stake sports betting appthe production process Stake Sports Bettingof injections and basic drugs, respectively，The author believes that the adverse reaction rate is higher、Sales price, especially the product, especially the bid price is lower than the market average cost，It is the product that is most likely to be subject to a strict flight inspection，Biochemical drugs、Sterile drug injection and proprietary patent medicine are categories of CFDA's focus。

 

  2. The new classification and consistency evaluation policy of chemical drugs is clear?

 

  New classification reform work plan for chemical drugs finally landed in March 2016，Detailed rules for the implementation of the application information in May。This is expected to improve the status quo of drug registration in the first half of 2016，Especially the declaration of generic drugs faced & ldquo; cliff -type & rdquo; decline。Declaration of chemical drug generic drugs is also related to consistency evaluation，Because the future of chemicals generic drugs must be evaluated through consistency。

 

  In the first half of 2016，CFDA specifically evaluate the consistency evaluation of generic drugs & rdquo; set column。As a project，A total of 28 related documents released by CFDA，Among them, there are 14 announcements issued in 2016，Among them, it does not include such files in one -time control drugs。But，Information released from the current clinical trial，and CFDA In the Impropon Medical Consistence Evaluation Work Conference held by CFDA on June 24, encourage enterprises to conduct consistency evaluation tests as soon as possible，Enterprises that truly launch consistency evaluation tests are very limited。

 

  Comments

 

  Most companies are still watching，I believe that there are three reasons:

 

  First，Which products do companies choose to make consistency evaluation，It can also be finally evaluated after the introduction of the Catalog of the Catalog of Consortium of Make Drugs before the end of 2018。

 

  2，Project price，Consistency Evaluation of CROs from 500,000 yuan to 15 million yuan, there are，and only 2 years from the time node in 2018，How to choose a reliable success rate and high cost -effective third -party enterprise for consistency evaluation，No conclusion。

 

  Third，Project method aspect，Although the policy documents have been promulgated a lot，But really execute，Enterprise will feel that consistency evaluation items are still in the stage of touching the river and crossing the river。& ldquo; In vitro dissolution test school & rdquo; and & ldquo; Biological equivalent in the body & rdquo;，and the four dissolved curves should be completely consistent with the original research! Most domestic companies who are accustomed to following are looking forward to & ldquo; those who eat crabs & rdquo; stake sports betting appthen make up the relevant information。

 

  stake sports betting appConsistency Test CFDA intends to adopt a centralized review and approval, horizontal comparison scheme，If the strict standards of the existing clinical verification are reviewed, the project is reviewed，The success rate can refer to the current clinical verification project。In view of this，I think，Consistency Test of the short -term benefits，It is a domestic company related products that have long been exported to Europe, America and Japan，and the production enterprise authorized by Europe, America, and Japanese production in China。

 

  3、Listing licensee is a pilot to reduce technical transfer steps?

 

  June 2016，The pilot area is Beijing、Tianjin、Hebei、Shanghai、Jiangsu、Zhejiang、Fujian、Shandong、Guangdong、The listing license system of ten provinces and cities in Sichuan was approved，The scope of pilot drugs includes: new drugs approved after the implementation of the plan、Consissed by the new standards consistent with the quality and efficacy of the original drugs，and some medicines that have been approved before the implementation of the plan。

 

  The holder system of the drug listing license is Europe、United States、Pharmaceuticals such as Japan and other developed countries and regions in the field of pharmaceutical supervision，This system adopts the management mode of the separation of drug listing licenses from production permit，Allowing the holder of the drug listing permit (holder of the drug listing license certificate，It can be a pharmaceutical manufacturer、R & D institution or scientific researcher) Self -producing drugs，or entrust other manufacturers to produce drugs。

 

  The pilot scheme allows clinical trial application or listing permit application to be approved to change the holder and production enterprise before and after，and formulated the corresponding change application procedure。The pilot plan stipulates to handle the holder to change the holder，Equivalent to the technical transfer approval of the original regulations，from the original independent administrative license，A supplementary application for the transition to the listing permit，It is an important manifestation of simplifying administrative license。and changing the application for the production enterprise supplementation is the scope of change in production venues，Equivalent to the original commissioned production approval。

 

  Comments

 

  I think，Allowing the production of across pilot areas is a highlight。The pilot scheme clearly allows the application holder to optimize the configuration of production resource in 10 pilot areas，Allowable holders can entrust the production enterprise to produce drugs without a new drug certificate，This means that the drug approval of the factory stake sports betting appthat did not obtain the stake sports betting app2010 GMP certificate in the pilot area can extend the life of the drug through the listing license system，No need to rush to take off the relevant drug approval of the drug before the second half of 2016。This will help cultivate some improvement of some quality system、Social reputation is good、Pharmaceutical manufacturers focusing on the production of production。

 

  In addition，The phenomenon of duplicate construction of resources in the past is expected to be solved。In the state of a state of limited pharmaceutical manufacturers and a limited increase in pharmaceutical market scale，The price of the drug production approval will return to rationalization，In the past, a large number of research and development enterprises that applied for the classification of old chemicals 3.1 drugs will also reduce the listing application of duplicate drugs。Repeated applications for drug registration in the pilot area will be reduced。For the development of new drugs，The holder is no longer limited by its own production qualification，It can be industrialized by the commissioning production method as soon as possible。So，Listing license system is more conducive to new drug research and development institutions that have experience in the past in Europe and the United States。