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、Listing license system (MAH) is the three major policies of 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。

 

  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 the CFDA specified date of CFDA is 317，Application for reduction of clinical trials, etc. 193 registration applications that do not need to be submitted，Announcement does not approve 40，Announcement withdrew 876，CFDA database has listed product approval number。

 

  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 unprocessed 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 on stake sports betting appthe 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 My stake betting appof stake sports betting appthe General Administration of Printing the Pharmaceutical Clinical Test Data Checkup (Interim) Notice (Interim) (Food and Drug Administration 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 supervision department on -site inspection date，No longer accepting the withdrawal application of drug registration applicants。

 

  April 1, 2016，"Announcement My stake betting appof stake sports betting appthe General Administration on the Application of the Registration Application of the Pharmaceutical Clinical Test Data Research (2016 No. 81)" decided that the newly received clinical trial declaration or imported by the 256 newly received after the announcement of the announcement will be announced after the announcement Drug registration application，Remove 75 registration applications that the applicant for the registered pharmaceutical registered applicant has withdrawn，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 for the Reporting Self -Reporting System of Open Drug Clinical Test Data"，Requires announcement of 181 drugs No. 81 of 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 application 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 pharmaceutical company's drug is established，Products with clear clinical efficacy will be more favored。

 

  It is reported，CFDA intends to check the production process，It is mainly aimed at the inconsistent actual production process and approval production process，and drug safety、Products that have an impactful effect。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。

 

  stake online sports bettingStake Sports BettingFrom 2007 and 2010 CFDA, the experience of verifying the production process of injections and basic drugs, respectively，The author believes that the adverse reaction rate is higher、Sales price, especially products with the bid price lower than the average market 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。

 

  New classification and consistency evaluation policies of chemical drugs clear?

 

  New classification reform work plan for chemical drugs finally settled in March 2016，Detailed rules for the implementation of the information of the application information。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 and generic drugs must be evaluated through consistency。

 

  In the first half of 2016，CFDA specifically evaluates the consistency evaluation of generic drugs & rdquo;。As the project，A total of 28 related documents released by CFDA，Among them, there are 14 announcements issued in 2016，excluding such documents in one -time control drugs。But，Information released from the current clinical trial，and CFDA in the Conference on the Consistency Evaluation Work Conference held by CFDA on June 24 encouraged enterprises to carry out the consistency evaluation test 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 is also the final evaluation of "Catalog of Catalog of Consistency Evaluation of Make Drugs before the end of 2018"。

 

  Second，Project price，Consistency Evaluation of CROs from 500,000 yuan to 15 million yuan, there are，It is only 2 years before 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 dissolving tests & rdquo; with & ldquo; Biological equivalent in the body & rdquo; tangled for more than half a year，and the four dissolved curves should be completely consistent with the original research! Most domestic companies who are accustomed to stake online sports bettingstake sports betting appfollowing are looking forward to & ldquo; those who eat crabs & rdquo; then make up the relevant information。

 

  Consistency 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，The success rate can refer to the current clinical verification project。In view of this，I think，Consistency test short -term beneficial，It is a domestic company related products that have already exported to Europe, America and Japan，and the production enterprise authorized by Europe, America and Japanese production in domestic real estate。

 

  MAH is the 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 range of pilot drugs includes: new drugs approved after the implementation of the plan、Make -making drugs that are approved 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 medicines。

 

  The pilot scheme allows clinical trial application or listing permit application to be approved to change the holder and manufacturer，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 transformation of the listing permit，It is an important manifestation of simplifying administrative license。And changing the application for production enterprises is the range of changes 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 Stake Sports Bettingentrust the production stake betting appenterprise to produce drugs without a new drug certificate。This means that the drug approval of the factory that did not get the 2010 GMP certificate in the pilot area can be extended through the listing of the drug life 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 credibility、Pharmaceutical manufacturers focusing on the production of production。

 

  In addition，The phenomenon of repeated construction of resources in the past is expected to be solved。In the state of force in the state of pharmaceutical manufacturers and the growth rate of the drug market,，The price of the drug production approval will return to rationalization，In the past, a large number of research and development enterprises who declared a large number of old chemical categories 3.1 drugs will also reduce the listing application of duplicate drugs。Repeated applications in the pilot area will be reduced。For the development of new drugs，The holder is no longer limited by its own production qualification，You can industrialize the drug by commissioning the 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。