July 25，CFDA Office Office for "Drug Registration Management Measures (Revised Draft)" is extensively solicited from the society。Compared with the Order No. 28 released in July 2007，The revised draft has changed greatly，It is worth studying for related professionals。

 

  As professionals who have been engaged in related industries for many years，The author believes that this revised draft is a continuation and summary of the preliminary policy。With the successful implementation of a series of heavy policies in 2015，The introduction of the new version of the "Administrative Measures for the Registration of Drugs" is inevitable。

 

  Read the revised draft in detail，First of all, it was the general goal spirit of the State Council "Opinions of the State Council on the Reform of the Reform Drug Medical Devices Review and Approval System" last August last year.、Solve the backlog of registration application、Improve the quality of generic drugs、Encourage research and creation of new drugs and improve the transparency of review and approval。

 

  Second，Localist System、Consistency evaluation of generic drugs、Clinical trial data and institutional stake online sports bettingstake online sports bettingself -inspection and other documents also run through it。Around the above goals，The revised draft has made a lot of adjustments。

 

  1. System of listing permit，Drug registration system is centered on the holder system of drug listing permits

 

  Drug listing license system refers to the management mode of separating listing licenses from production permits。Under this mechanism，Listing license and production license independent，Listing license holders can produce themselves，You can also entrust other manufacturers to produce。Listing license holder's safety of drugs in accordance with the law、Effectiveness and quality controllability is fully responsible。As a more popular system，The meaning of encouraging innovation is strong，And can inhibit the low level of pharmaceutical companies from the source，Then promote the rapid development of my country's pharmaceutical industry。

 

  For the list of people & ldquo; applicant & rdquo;，The revised draft was redefined，from the original & ldquo; domestic institution & rdquo; replaced by & ldquo; domestic subject & rdquo;，Echo the system of listing licensee; and based on the beneficiary，The responsibility of the applicant worsen，If the responsibility for the development and application process、Drug research and sample trial production can be traced back to the whole process。

 

  2. Rebate the innovation of drugs，Clear & ldquo; Encourage clinical value -oriented drug innovation & rdquo;

 

  Article 70 stipulates & ldquo; Innovative drugs shall have clear clinical value; improved new drugs should have obvious clinical advantages than the original variety。& rdquo; This can avoid some unnecessary & ldquo; pseudo innovation & rdquo;，Second, it can also reduce the application of simple dosage type and the base alkaline base of registered backlog。

 

  Convenience for bidding for many years，Enterprises do full effort on simple modifications and increase specifications，The result is the severe backlog of CDE、The main body of stake online sports bettingstake sports betting appthe real innovative spirit exit the market，so that & ldquo;、Sovaldi & rdquo; Innovative drugs such as it are difficult to appear in China。This time with clinical value and advantages, it is a benchmark，It is expected to completely stimulate the enthusiasm of research and development with the main body of innovation。

 

  3. Evaluation criteria for generic drugs and biological drugs，Clear & ldquo; consistent with the quality and efficacy of the original drug or the efficacy or similar & rdquo;

 

  This reform is in line with international standard，The orange book system of the United States and Japan has been implemented for many years，Its core content is to encourage drug price competition by accelerating the approval of general -purpose drugs，At the same time, extend the patent period of the drug to make up for the effective patent time lost due to drug development。

 

  Orange Book is an alternative drug information for patent prescription drugs recommended by FDA and other FDAs，Selection of reference preparations is extremely strict。my country is a major generician country，Due to historical reasons，There is no strict regulation of the choice of reference preparations，Some generic drugs that have been listed are serious in terms of quality and efficacy，New standards this time，It is expected to stimulate the market to provide high -quality generic drugs，​​Change & ldquo; phenomenon of bad coins & rdquo;。

 

  4. Formulate a priority review system

 

  Revised in the revised draft，Establish a priority review system based on clinical needs and drug characteristics，The most direct role of this system is the qualifications of priority review through rewards，Time to shorten the drug into the market，Fast recovery cost。

 

  This system has implemented this system for many years，From historical data，Drugs identified by priority review are indeed better than non -preferred drugs in terms of efficacy or side effects。my country's implementation of this system will make the drugs that meet the above requirements.stake sports betting appMy stake betting app，so as to save more patients' lives or improve their quality of life。

 

  5. The Provincial Bureau will play a greater role

 

  Article 5 of the Revised Draft，Provincial、Autonomous Region、The food and drug supervision department of the municipality directly under the Central Government undertakes the supervision and management of drug registration related matters in the administrative area，and undertake the drug registration items entrusted by CFDA。The daily supervision of the provincial pharmaceutical regulatory department in the administrative area will become its focus。Here reflects & ldquo; Prevention of prevalence & rdquo; is the highest state of risk management。

 

  6. Emphasize communication and establish a communication mechanism

 

  Communication of the drug review institution and the applicant，The clinical stage regulatory authorities and applicants、Researchers and other communication; pre -clinical、During the clinical trial process and the communication before listing, the communication runs through the revised draft。

 

  Actually，Communication work is very common during the FDA review process，Through full communication, you can speed up your understanding of the application project，It is helpful to improve the efficiency of review。In fact，Domestic applicants and drug review agencies also communicated when applying for projects，but，It is the first time in the form of posting a post。

 

  7.

 

  Just like communicating with a post to become a regulation in the manuscript，There are many places in the text that the original agreement becomes a provision。Such as the establishment of an expert consultation system for the drug review institution，The opinions of earlier experts became CDE or the reference of the provincial bureau.，Appearing in a post -post，Disposition of the importance of this system。

 

  but，Some agreed vulgaris becomes a provision，I have reservations。For example，It is well known that corporate recruitment registration commissioner，is to approve your product as soon as possible，In My stake betting appthe recruitment session, My stake betting appit has defined its duties，and restricted related majors。

 

  8. Clinical trial arrangement is more flexible

 

  Article 30 The arrangement of clinical trials is new，The stipulated in the text stipulated that clinical trials can be according to Ⅰ、Ⅱ、Phase III order implementation or cross overlap，You can also conduct corresponding clinical trials on the basis of existing clinical trial data。

 

  Of course，Except the above 8 aspects，And the state for drugs and medicinal packages、The listing application of medicinal auxiliary materials to implement some important changes such as related review and approval，The purpose is to ensure the safety of drugs、Effective、Principles of controlling quality。