Recently，The State Drug Administration officially issued the "Notice of Exemption or Simplifying the Equivability (BE) Test Variety (No. 32, 2018)，It is determined that the 48 varieties of varieties that can be exempted or simplified in the category of the variety of generic drugs that need to be completed by the end of 2018 can be eliminated.，Where，It can be exempted from 15，Can apply for exemption from 17，It can simplify human BE varieties (including exempting empty stomach BE and exempt meals) 13，Carrying for human PK Stake Sports Bettingcomparative research and evaluation of safety varieties。

 

Available or simplified human biological equivalent (BE) test varieties

Not relaxing standards

    According to the "Principles of Exeminating Guidance of Human Bio Equal Test Examination"，Drugs are divided into four categories，Including: "High solubility、High permeability "BCS1 category，"Low solubility、High permeability "BCS2 category，"High solubility、Low permeability "BCS3 category and" low solubility、Low permeability "BCS4 category。Among them, type 1 and 3 drugs，As long as the other auxiliary materials in the prescription does not significantly affect the API absorption，No need to prove the possibility of biological utilization and biological equivalent in the body。

It is reported，BCS1 drugs need to prove that the drug is high -soluble and high permeability，Only to obtain biological equivalent exemption，Imitation drugs and RLD must be quickly dissolved，and the preparation does not contain any auxiliary materials that affect the absorption rate of the main medicine component and the degree of absorption; drugs in BCS3 claims to prove that the drug is highly dissolved，Both generic drugs and RLD can dissolve very quickly，and the two prescriptions are exactly the same，Similar amount of composition of composition，Process amplification、When changing Stake Sports Bettingafter production and listing，The prescription of the preparation should also be exactly the same。

Consistency Evaluation Office of the Consistency Evaluation Office of the Quality and Effect of the Photos and Consistency，The industry does not mean that the consistency evaluation criteria already have consensus on exemption BE or simplified BE。"Recommended exemption or simplified BE variety is based on BCS classification principles，Reflect that the standards of consistency evaluation in my country are in line with international standards，Reasonable exemption or simplified scientific regulatory attributes that conform to the medicine itself。"The person in charge of the R & D department of an enterprise said，The company already has variety acceptance consistency evaluation applications，Apply for simplification in accordance with the BCS classification principle。

Enterprise actively speed up

CDE issued the "Notice on Soliciting or Simplified Variety Tests (BE) Variety Variety Variety" in November 2017，A total of 57 products involved，More than 6,000 batches，Divided into two categories: "Exemption BE" and "Simplified BE"，Among them, 44 BE varieties can be exempted; in December of the same year, CDE issued a notice again，Formally exempt the consistency evaluation clinical trials of polyethylene diol 4000 related products。

To further Stake Sports Bettingspeed up the consistency evaluation of generic drugs，At present, the country has released consistency evaluation of various supporting documents，and combing a comprehensive and in -depth specification around the reference preparation，Multiple batch reference preparation directory has been announced one after another。The self -review system has been changed since the filing system，The consistency evaluation of the entire chain of the industry and supervision is significantly accelerated。

In terms of variety，The list of 48 varieties officially released this time，The number of approved number of Renididine capsules、metronidazole tablets、For acetylphenol tablets、Different tobacco slices、Vitamin B6 tablets、Vitamin B2 tablets and other varieties are all listed.，Polyetteritic glycol 4000 scattered、Potassium chloride particles、Amber sarcasis ferrous tablet、Left Vinkin Tablets, etc. with a small number of quantities, including the small number of quantities, also includes inside。

Enterprise aspect，Many consistency evaluation applicants have carried out related research and declaration in accordance with the path of exemption or simplifying BE，For example: the application for the consistency evaluation application of the Mengshou Shishisan of Xianyin Pharmaceutical has been accepted; China Resources Shuangheli Min stake online sports bettingPharmaceutical (Jinan) has carried out postpinnazole tablet meals for meals; Existing Evaluation of Stone Medicine Group Ouyi Pharmaceutical Declaration，Changzhou Pharmaceutical Factory、Shandong Xinhua Pharmaceutical and Shandong Luo Xin Pharmaceutical have also started Catopoli empty stomach。