July 25，The State Food and Drug Administration officially released the "Measures for Drug Registration (Revised Draft)" (hereinafter referred to as revised drafts)，and asking for comments on the revised draft。The deadline for soliciting opinions is August 26, 2018，One month's time。

 

  Revised drafts have been circulated in the WeChat friends circle.，This time finally revealed the true face of Lushan。The following is the focus of attention summarized from the document:

 

  1, pharmaceutical registration, clinical needs will become oriented

 

  First of all, priority review。Chinese drug registration stake online sports bettingis slowly spit out too many times，Although the State Administration has a trick to draw salary at the bottom of，Clinical experimental verification，Life reduces N multi -workload，It will be impossible to become possible。but，Pharmaceutical companies want to develop，The speed of drug registration is still important，Speed ​​is money and market。So the priority review is particularly worthy of attention。

 

  What are the regulations in the revised manuscript?

 

  Article 16 stipulates that the State Administration of Food and Drug Administration establishes a priority review system based on clinical needs and drug characteristics。

 

  Second，Clinical orientation is reflected in，Article 70 of the Revised Draft stipulates: Before the application of listing，The applicant shall fully evaluate its application，Innovative drugs should have clear clinical value; improved new drugs should have obvious clinical advantages than the original varieties; generic drugs should be consistent with the quality and efficacy of the original drugs。

 

  The quality and efficacy of generic drugs and the original research are consistent，This is still clinically determined whether generic drugs can be available。For innovative drugs，Clinical is also a gold standard for judging，After this regulation,，Enterprise can be listed in the previous dosage and specifications，The road to becoming a new medicine can no longer be available。

 

  stake online sports betting2, two major advantages in Chinese medicine.

 

  Revised Draft Article 72: Chinese Medicine New Drugs obtained by the listing permit，Stop accepting the listing of the same variety。

 

  So as long as you will be a new Chinese medicine for Chinese medicine，No need to apply for Chinese medicine varieties alone，Directly obtained，and not accept the listing of the same variety。This clause is for Chinese medicine innovative drugs，It is a good good news，Proper market protection，For Chinese medicine innovation，The strong support。

 

  but，To become a Chinese medicine innovative medicine，Chinese medicine companies must also do my homework。The number of approval of Chinese medicine innovative drugs in the past two years has always been relatively small，Among them, there may be a reason why Chinese medicine innovation needs to work harder，On the other hand, it is also the result of the tense approval of Chinese medicine innovation drugs。

 

  On the review of Chinese medicine innovative drugs，As mentioned above，Clinical will be an important orientation，In addition，The file is still clear，Chinese medicine new medicine prescription medicine contains endangered medicinal materials，Unable to guarantee the sustainable resource，Decision to make no approval。Application for registration of traditional Chinese medicine varieties，This point should be avoided。

 

  3, will return to the General Administration after the drug registration?

 

  Article 71: The applicant My stake betting appintends to apply for a drug listing，The application information shall be submitted to the State Administration of Food and Drug Administration。Food and Drug Administration shall be within the prescribed time limit，Formation of the application information，Meeting the requirements，issue a notice of acceptance;，Failure not to accept notice，Explain the reason。

 

  105 Article 105 Food and Drug Administration for the effectiveness of drugs、Safety and quality controllability such as no effect，Implementation filing management。

 

  The filing of this drug registration application to the unsatisfactory changes is responsible for the General Administration，Expected future，​​Drug registration must be returned to the General Administration，It has nothing to do with the Provincial Bureau。

 

  4, Pharmaceutical Listing Reviews focused on:

 

  Article 77 The review of the application of drug listing，Should focus on:

 

  (1) The clinical value of innovative drugs;

 

  (2) The technical innovation and clinical advantages of improved new drugs;

 

  (3) The consistency of the quality and efficacy of generic drugs is consistent with the quality and efficacy of the original drug;

 

  (4) Similar biological drugs are similar to the quality and efficacy of the original drug;

 

  (5)、Drug pathway、The consistency of functional and traditional applications，and non -clinical safety;

 

  (6) The stability and quality controllability of the product of the listed scale;

 

  (7) The scientific, standardized and readability of the manual.