The official website of the Pharmacopoeia released the "China Pharmacopoeia 2015 (three parts) to increase the renovation content to be added"。This time the publicity involves vaccines。Added content types are mainly: immunogenicity、Differential、Virus activation verification。

 

  Nothing strange to add repair，What attracted the attention of the little demon is that there is a sentence in the original content of immunogenicity & ldquo.

 

  1. Unified method and self -evidence

 

  Always，Pharmacopoeia is for me，The biggest role should be a unified method。Every time I declare a new product，We will read the Pharmacopoeia the first time，Find this variety or similar variety、Guidelines for verification methods or analysis methods。Stake Sports BettingEach Stake Sports Bettingone has done medicine research and development，Analysis method development，Analysis method verification，Registered employees know the meaning of the Pharmacopoeia for us。Aponement of the Pharmacopoeia，We will definitely use the medicine method，Because for us，This saves a lot of things。Even said，This is also the regulatory authority unwritten regulations，Not using the pharmacopoeia method, it will cause a lot of & ldquo; self -evidence & rdquo; trouble。Although we say that the main responsibility of the drug is the company itself。The main responsibility here，Including the development method of developing products in the research and development process、Verification method，But the pharmacopoeia method is a pointer method。Pharmacopoeia make the method unified，During supervision、During the review，It has also achieved relatively unified standardization。It is mainly reflected in the process of registration inspection，Unified use of the pills method，The work of the drug inspection office is also relatively standardized。Under the same method，The differences between different products seem to be reflected。

 

  2、For the first time I saw & ldquo; Register & rdquo;

 

  The third part of the Pharmacopoeia is planned to add content，Change some immunogenic content into self -verification，Clinical according to the requirements of the registration management。Verification method is still a guide，It can be understood that the verification method is still uniform，But this seems to be the My stake betting appstake online sports bettingfirst time that the registration management requirement & hellip; & rdquo; Pharmacopoeia has always been formulated based on the general situation of the listed products，It is also often criticized for too high or too low，Some people have questioned that the pharmacopoeia standard has been used as a commercial barriers。This time I mentioned the MCB change verification in immunogenicity，If necessary, it should be clinical & hellip; this sentence is more like the technical guidance principle from CDE，Administrative Measures issued by the Registration Division 2 -level document & hellip;

 

  3. How to write the new registration management measures?

 

  Requirements for changing declarations，It seems that the administrative process needs to refer to the registration management method，Requirements need to refer to the principles of technical guidance，Analysis method Follow the Pharmacopoeia & Hellip;，I am afraid that many changes will be loaded into the Pharmacopoeia，But the acceptance review is CDE，Approval is the registered department，I hope that many parties will be consistent。Look at the current text，Pharmacopoeia requirements seem to be based on registered management measures，It is also a good thing for pharmaceutical companies，At least the pharmacopoeia and registration management measures are theoretically consistent。But the & ldquo; when necessary & rdquo;，Who said it? When is it & ldquo; Necessary & rdquo;?。Pharmacopoeia's additional time for this time，I do n’t know if it will appear stake sports betting appstake betting appbefore the new registration management measures.，We really don't know how the new registered management measures will stipulate the main seed change part，Clinical requirements for immunogenic testing。It looks like，Registration management measures must be clearly stipulated，Otherwise, from Pharmacopoe & ldquo; Link & rdquo;

 

  4. Who will use the medicine?

 

  In the chat with friends，We suddenly mention this topic。Doctor? patient?。Then the pharmacopoeia is for pharmaceutical people (maybe the only population of Pharmacopoeia)，Except a unified method，Provide basic market standards，Does it also limit the personalized research and development and discovery of the method? If there is no pill，Will we find more targeted according to the specific product，Slightly different personalized analysis method，Is this analysis method a more refined、Science、Methods that are conducive to product research? If the pharmacopoeia is a method that must be followed，Will the company still find more accurate analysis methods? Pharmacopoeia added，Can I keep up with the speed of R & D and development? At present, domestic R & D personnel use more about foreign relevant standards、Guidance principles or Chinese Pharmacopoeia? Daily analysis and release method，It should follow the registration approval method，If the pharmaceutical method is changed，All registration standards and methods used to use this method need to be changed，Is this suitable for all products?

 

  This time I ’m proposed Stake Sports Bettingstake online sports bettingto be repaired and publicized，From the perspective of the little demon。From the perspective of the little demon，But it's not a trivial matter。One sentence，Posted directly for clinical，I proposed to follow the registration management measures，Also soliciting opinions when the new version of the registration management measures are not introduced & hellip;，Please think about it，Make opinions in time，Feedback information。