Compared to the current version of "Administrative Measures for Drug Registration"，The revised draft that is about to cut off coming off will be registered and supervised by the drug registration.，Supervision is better clinical、Serving the society，New requirements in multiple notices or opinions to improve registration efficiency、New measures、New ideas include。

 

  Changes in various details

 

  such as clinical research、Dynamic supervision of the entire process of pharmacy research，Record System Management，The whole process of research information can be traceable，& ldquo; Quality consistency (chemical) or similar (biopharmaceutical) requirements of & rdquo;，& ldquo; The clinical value and demand orientation of the best & rdquo;，Related reviews of accessories and packaging materials，Review approval of the preparations for the listing of the listing of the raw drugs and the drug drugs alone，Registration license system，Encourage the research and development of children's medicine，The clinical value of innovative drugs，Evaluation stake online sports bettingof the quality of drugs according to the listing scale，Pharmaceutical pre -clinical safety evaluation research must be carried out in the laboratory of GLP, etc.。

 

  Details change also include: & ldquo; Clinical verification samples should be as prescription process after listing、The consistency of quality control & rdquo; requirements，The requirements for communication collaborative mechanism and the requirements of communication time guarantee，Mechanism of strengthening information on information，The requirements for sustainable guarantee of traditional Chinese medicine development resources，Three original principles of the research and development of classic Chinese medicine classic recipes，Study on the change of approved products，Third -party detection participation and effectiveness，Requirements for registering payment & hellip; & hellip;, etc.。

 

  The above changes make administrative supervision more laws to rely on。Not only that，Revised drafts are registered management of drugs、The understanding of drug research and development reflects the rigor and science of this field。

 

  For example, Article 7 of the revised draft: & ldquo; The State Administration of Food and Drug Administration Establishs scientific specifications、Perfect and efficient review and approval system，Timely evaluation and improve the relevant system、specification、Standards and Management Measures，Effective operation of the drug registration system。& rdquo; Article 21: & ldquo; Pharmaceutical listing permit shall be based on the evaluation conclusion based on the level of technology and scientific cognition，Make an administrative decision，The applicant shall for the safety of the available medicines、Effective、Quality controllability, etc. For continuous research。& rdquo; Article 30 indicates: stake betting app& ldquo; clinical trials can be according to i、Ⅱ、Phase III order implementation or cross overlap，Corresponding clinical trials can also be carried out on the basis of existing clinical trial data。& rdquo; It clearly points out that the review should be developed with the development of science and technology，Changes with the environment、Dynamic adaptability requirements for understanding，Policies should be introduced at any time in time。

 

  Research endless，Once a medicine is born，and have clinical value，So，Study on it should not stop，Questions about drugs & ldquo; product force & rdquo;，is the subject of its eternal life cycle。Studies can also be repeated，Compulsory requirements without fixed format order。

 

  Based on this understanding，Also adopt a mode of permanent ID card management for drug registration。For example, Article 19 of the revised draft: & ldquo; The State Administration of Food and Drug Administration implemented the original number management of drug registration。The applicant gets the original number after the drug clinical trial application or the drug listing application is accepted，All drug registered materials submitted in the future must indicate the original number。In principle, all the indications involved in clinical trials are managed by the same original number。& rdquo; Article 24 & ldquo; The applicant shall follow the opinions formed by the specific implementation mechanism，Submit supplementary information & hellip; & hellip; & rdquo;，It will be an identity coding for any registered submission (including filing) in its life cycle，is the corresponding identity recognition，It is guaranteed that product registration information can be traced on a lifetime，Regulatory significance is significant。

 

  Another，Definition of drug registration，Reflecting the progress of the policy。The current version of stake online sports bettingthe "Administrative Measures for the Registration of Drugs" believes，& ldquo; Drug registration is a decisive process of administrative review & rdquo;，Revised the manuscript humblely pointed out，& ldquo; Drug registration is a process of administrative decision based on comprehensive evaluation of technology。& rdquo; Here，It also proposes a point that needs to be perfected in the definition of drug registration: It is recommended、Article 64 & ldquo; & hellip; & hellip; make the process of administrative license decision & rdquo; change to & ldquo; & hellip; & hellip;。

 

  Excellent Chinese medicine varieties have preferential treatment

 

  Revised draft Article 72: & ldquo; The new Chinese medicine new medicine that obtained the listing of the listing license is also protected by the Chinese medicine variety，Stop accepting the listing application of the same variety。& rdquo; Article 82: & ldquo;，The new name of the new medicine shall be approved by the National Pharmacopoeia Commission。Food and Drug Administration's pharmaceutical review agency shall submit the new drug approved name approval suggestion to the Pharmacopoeia Commission within 7 days of the technical review，The Pharmaceutical Code should make a decision to approve the general name of the new drug within 30 days，and notify the drug review agency。& rdquo; This reflects the streamlined institutional、Coordination in the registration of drugs after adjustment、Collaborative，Reduce the specific implementation of the workflow in actual business、Land。

 

  Chinese medicine is the original of China，But its real status is still embarrassing。Revised draft Article 122 points out: & ldquo; Chinese medicine、Natural drug innovation drugs can automatically obtain Chinese medicine varieties protection & rdquo; while applying for listing permits，Although the preferential treatment of Chinese medicine innovative stake online sports bettingdrugs is given to Chinese medicine innovative drugs，But at the same time, it is also clearly conceptual as an innovative drug of & ldquo; natural drugs & rdquo; special rights that can be given & ldquo; Zhongbao & RDQUO;，Sexual tangled selection，In fact, it reflects the encouragement and support of the policy to develop traditional Chinese medicine in the policy。

 

  Another，Compared with current regulations，The establishment of the revised draft in the monitoring period of the new drug、Application in drug registration control、Application for registration of drugs that others have obtained by Chinese patent rights，There are more reasonable revisions，You need to follow。