Recently，The official website of Shanghai Food and Drug Administration issued the "Shanghai Food and Drug Administration on the Implementation Opinions of Deepening the Reform of" Deepening the Management "Reform and Optimization of Administrative Approval，Persistence insists on the framework of laws and regulations，Prerequisites that do not decrease based on approval standards，Promote various reform measures scientifically，Resolutely follow the "four most strictest" requirements，Implement the main responsibility of the enterprise，Strengthen the supervision responsibility for the entire process of regulatory authorities，Further optimize the biomedical industry environment，Specifically sorted on 53 administrative approval items one by one，Put forward system integration reform measures and strengthen the regulatory plan for post -incidents。
It is worth noting is，stake online sports bettingIn stake online sports bettingthe "Drug Re -Register" matters，Clarified "Strengthening and Registered Drugs and Post -event Supervision" "" Oral preparations for oral preparations in the basic drug catalog in the country's basic drugs will not be registered again "" Give to eliminate "。
289 variety of time urgency
Current，The 5 batches of the 5 batches of the drug list passed by the State Drug Administration，"289 varieties" only have 13 (24 product regulations)。Because the 289 varieties are mostly common medicines，Fierce market competition，Booth profits，Previously, the "threshold" of the "threshold" that completed the consistency evaluation of the end of 2018 for a long -term market expectation。This expectation is obviously inconsistent with the scientific supervision ideas and industrial upgrading of the drug authority。
Industry insiders pointed out，In recent years, whether it is a regulatory department or a pharmaceutical company，The importance of the importance of consistency evaluation is becoming more and more deeper，The supervision scale of scientific review and approval is becoming more and more open，But opening does not mean that there is no threshold。"The time left for 289 varieties at the end of 2018 is indeed not much，Finally, either insist on completing the evaluation，Either you can only wait for the registration certificate to be eliminated naturally，Sending the threshold for relaxation is unrealistic。”
This time the Shanghai Pharmaceutical Supervision Bureau issued a document to optimize administrative approval，Simple administration and decentralization to strengthen the full process at the same time、Drug science supervision of the whole life cycle，and clarify the product that eliminates the requirements stake online sports bettingof the consistency evaluation Stake Sports Bettingrequirements of generic drugs at the end of the year，It has reflected the overall idea of drug supervision in the new period to a certain extent。
time to this day，"289 variety" has entered a life -and -death countdown，Can it be able to complete the consistency evaluation of generic drugs at the end of the year and always worry about the work industry。According to the Midnet data, it shows，As of July 31，205 acceptance numbers (excluding acceptance numbers that have passed or do not approve or pass the consistency evaluation)，87 acceptance numbers belong to "289 varieties"，36 varieties。
Among these 36 species of consistency evaluation，There are 10 people who belong to the whole body for anti -infective drugs，8 belong to the digestive system and metabolic drugs，Two major categories of products occupy half of the mountains and mountains。In addition，From the perspective of sales data，Anti -infection drugs for the whole body、The digestive system and metabolic drugs were in the terminal chemicals of China's public medical institutions in 2017，ranked first and second with 19.95%and 16.58%of the market share, respectively，The market volume is huge。
Imitation drug declaration is in line with international
Recently，The State Drug Administration issued the "Notice on the Requirements on the Requirement of the Requirement of the Research and Application Information of the Long -term Stability of Chemical Physical Drugs (No. 82, 2018)，It aims to promote the requirements of the long -term stability of chemical generic drugs and the requirements of the requirements of international technical requirements，Accelerate the progress stake online sports bettingof the consistency evaluation of generic drugs，Encourage new generic drug declaration。stake sports betting appNotice requirements: Application for chemical generic drug stake sports betting applisting and the quality and efficacy consistency evaluation application，Under the premise that the registered production scale meets the requirements，The application information needs to include at least three registered samples for 6 months long -term stability test data。
Not long ago，CDE has released "Registration Category 4、5.2 Class of chemical generic drugs (oral solid system) biological equivalent research batch sample batch requirements (trial) "，To ensure the consistency of the quality and efficacy of batch sample sample samples in order to ensure commercial production batch sample sample samples and biological equivalent，Requirements: For tablets and capsules (including slow -release agents、Chewing tablets、Crowding tablets, etc.)，BE Study batch sample batch (with the amount of feeding，Same below) Should be less than 100,000 preparation units; for scattered agents、Granules，BE Study batch sample batch shall not be lower than the proposed commercial production batch 1/10。
Combined with the actual development of industrial development at home and abroad，Drug supervision level upgraded oral solid generic drug registration and generic drug consistency evaluation technology standards are constantly leaping to higher steps，Strive for international integration、Determination of the quality of domestic generic drug products is determined and unswerving。
The performance of the market also implements the theme of industrial upgrading，Shanghai、Shaanxi、Jiangsu、Ningxia、Inner Mongolia、Liaoning、Shanxi、Hubei、Zhejiang、Qinghai and other provinces (cities、Autonomous Region) has published specific plans or opinions that pass the consistency evaluation Stake Sports Bettingof drug procurement，For varieties that have reached "1 (Original Research) +3 stake online sports betting(Imitation)" pattern，Hangwang purchases are tightened to varying degrees。
Industry person expectations，With the implementation stake online sports bettingof the consistency evaluation policy of generic drugs，and the provinces have launched a new round of drug procurement，Purchase of drugs through consistency evaluation is good to land one after another，Products that cannot pass the consistency evaluation of generic drugs in the future will usher in a more violent industry shuffle。
