Business Club November 22 The revision of the "Administrative Measures for the Registration of Drug Registration" issued by CFDA (draft) for comments，It has attracted widespread concern and heated discussion in the industry。Starting from this issue，This newspaper will invite the government、Association、Learn to discuss this with business people，Collect and analyze related suggestions，For the reference of all parties for all parties，Please pay attention to readers。
 
Recently，The State Food and Drug Administration (CFDA) issued a revision of the "Measures for Registration of Drugs" (draft)，Amended on the relevant terms of the preliminary management measures of drug registration。
 
According to reporters' observation，This revision mainly adds clauses to adapting and encouraging drug innovation，Emphasize the connection with the patent law，Improve the relevant terms of the Stake Sports Bettingmonitoring stake betting appperiod management，and adjust the requirements for the inspection procedures for the registration production site of generic drugs。
 
From the perspective of the interview，"Draft for Consultation" has aroused great attention in the industry。Generally speaking，Entrepreneurs and relevant scientific research experts generally recognize the content of the "Draft for Soliciting Opinions"，and think，On the one hand, CFDA regulatory work continues to connect with international regulatory concepts and systems，More open and scientific，For example, a revision instructions issued with the "Draft for Soliciting Opinions"，and some reasonable calls of the enterprise are adopted; on the other hand, it has more substantial adjustment of the encouragement policy of drug innovation。
 
but，In two batches of & rdquo; and adjustment of the approved on -site inspection procedures for the reporting of generic drugs & rdquo;，Enterprises and industries are still discussing fiercely。
 
Encourage innovation to speed up
 
& ldquo; The scientific research community is very concerned about the "Draft for Soliciting Opinions"，Overall，I feel that regulatory authorities follow the overall situation of the development of national political and economic development，On the basis of adhering to scientific supervision，Continuously optimize the supervision method, etc.，I think the "Draft for Soliciting Opinions" generally affects more。& rdquo; Fan Xiaohui, deputy director of the Zhejiang University Drug Information Research Institute, who had worked at the FDA, said in an interview with this newspaper.。
 
Director of the Registration Department of Green Leaf Pharmaceutical Group in China Yu Chun Na said，Overall，"Draft for Solicitation of Opinions" has not changed much，Green leaves are most concerned about the newly added clauses about adapting and encouraging stake betting appnew drug stake online sports bettinginnovation，and the actual review time of the current Drug Review Center is different from the "Draft for Soliciting Opinions"，How to solve the problem of reviewing timeout after the revised "Drug Registration Management Measures"。

The reporter learned，The specific content of encouraging innovation is mainly three aspects: First, the "Draft for Soliciting Opinions" emphasizes the connection with the Patent Law，Delete the relevant clauses that can be declared within two years before the patent expires of the patent due to the patent -expired drug;，Emphasized during the monitoring period of the new drug，The State General Administration will no longer accept the same variety、Modified dosage type、Application for registration of imported drugs，But for the registration application of other applicants，You can continue to apply for the application in accordance with the drug registration application and approval procedures; the third is to add clauses such as applicants and processes such as clinical clinicals。
 
& ldquo; Amendment to these clauses，Accelerate my country's imitation drug development and listing speed，Enhanced drugs and sex have important functions，and to some extent，It will continue to expand the international vision of China's new drug innovation and the global strategic vision of the company。& rdquo; R & D people in a pharmaceutical company in Guangdong, as analyzed。
 
Amendment to the monitoring period，Analysis of the person thinks，According to the current drug research and development situation，It is normal for a number of companies to declare a certain product at the same time at the same time，New clauses if it is implemented，It means that the pressure of corporate competition will be even more prominent，But full competition、It is good to improve the quality of medicines。
 
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Drug registration management stake betting apprelated content，It is a major problem that is related to my country's pharmaceutical innovation and corporate pharmaceutical research and development capabilities and achievements，"Draft for Consultation", it has also attracted great attention from the business community，And actively put forward revision opinions and suggestions。
 
From the perspective of the reporter's interview，The revision of the relevant provisions related to the examination and approval of generic drugs is the more intense content of the current industry: First, the "Draft for Consultation" is adjusted to the inspection of the generic drug production site to the completion of clinical trials and technical reviews，Before the listing permit; the second is to use & ldquo; two batches of & rdquo;。
 
In terms of on -site inspection，CFDA emphasizes the adjustment of the link，To ensure the quality of generic drugs，Reduce the investment in corporate resource investment in the approval of generic drugs，Improve the efficiency and quality of on -site inspection more effective，But the company is generally worried that the application will be more complicated; the terms of the two batches of & rdquo;，is generally lower than the industry's expectations。
 
Green Leaf Group has completed written materials for comments on "Draft for Solicitation Opinions"，Prepare to submit to the relevant departments。On the specific content，The company recommends that in the "Draft for Soliciting Opinions"，1 is to clear the rapid approval process of generic drugs，The national list of imitation drugs that enter the fast approval channel regularly; the second is to make special preparations such as lipids、Micro balloon、micro -milk, etc. Innovative drug My stake betting appprocedures，For detailed regulations，and shorten the review stake betting apptime of the special preparation; the third is to clearly declare the imitation and non -prescription medicine、Prescription drug conversion non -prescription medicine、Prescription drug conversion dual -cross variety、Declars to the process of imitation dual -cross varieties; the fourth is to increase the acceptance of the drug supervision and management department in accordance with the prescribed time limit、review、penalties for approval, etc.。