2020 Inventory . . 343 varieties were undertaken, 201 varieties have been evaluated Fosun, People's Fu declaration led Qilu, stone medicine big winner

On February 6, 2016, the General Office of the State Council issued "Opinions on the Conduct of Consistent Evaluation of the Quality and Efficacy of Generic Drugs", and the work related to conformity evaluation officially began, after four years, the reform work related to consistency evaluation has been carried out in an orderly manner, the medical reform has also achieved phased results, more and more generic drugs have passed the test of consistent evaluation, and the quality and efficacy are consistent with the original drug.
2020 is coming to an end, with only ten days left, under the shadow of the "Black Swan" incident in the new crown outbreak! Over the past year, medical reform has advanced in depth, and the work related to consistent evaluation has continued.
according to the database statistics on the registration and acceptance of pharmaceutical and intellectual drugs, as of December 21, 2020, the number of CDE acceptance and conformity evaluation received reached 2604, of which 875 have been evaluated.
883 acceptance numbers were accepted, with injections exceeding 50%, and Fosun Pharma led by a total of 883 acceptance numbers (343 varieties) as of December 21. ) The declaration consistency evaluation was accepted, down 14.93 percent from 1038 receiving numbers in the previous year, and 493 receiving numbers were evaluated, an increase of 76.70 percent over the 279 receiving numbers in 2019.
2020 consistency evaluation declaration / through trend chart From the dosage form of drug declaration, if 2019 and before mainly solid preparation tablets, 2020 has entered the phase of consistent evaluation of liquid preparations, especially in May this year, CDE issued injection consistency evaluation work after the official working paper, especially in the trend of gradual normalization of collection, a large number of injections competing for consistent evaluation.
according to the data consistency evaluation and analysis system statistics, in 2020 the total number of CDE acceptance of injection declaration reached 475, accounting for 53.79 percent, tablets only 32.5 percent.
2020 consistent evaluation of generic drug declaration dosage form ratio chart from the variety declaration acceptance number ranking, 2020 injections are also a first.
The drugs declared top10 are all injections, of which the maximum number of sodium cephalosporine for injection, up to 24 acceptance numbers, followed by 18 reception numbers for sodium omeprazole for injection, followed by 17 reception numbers for injection cephalosporine.
variety declaration acceptance number TOP10 from the number of varieties, variety declaration enterprises in the top 10 drugs have 7 for injection, of which 15 enterprises with omeprazole sodium for injection were declared to be accepted, injection with sodium vitolazole and injection head gun sodium each have 12 declarations.
variety declaration enterprises TOP10 from the enterprise point of view, the largest number of enterprises to be reported for Fosun Pharmaceutical subsidiary Suzhou Second Leaf Pharmaceutical, there are 12, followed by Shandong Luoxin and Qilu Pharmaceutical, both have 11 acceptance numbers to be undertaken; Variety look, there are 8 varieties of human-fu medicine was undertaken, for the 2020 declaration to accept the largest varieties of enterprises, followed by Chinese medicine, Tianjin Jinyao, Shi Medicine Ohyi, Chengdu Beite and Qilu Pharmaceuticals, each has 7 varieties.
enterprise declaration acceptance number TOP10 enterprise declaration variety TOP10 it is worth mentioning that Fosun Pharmaceutical subsidiary Suzhou second leaf pharmaceutical 2020 declaration of 12 acceptance numbers are injection varieties, respectively, injection cephalosporine sodium Shubatan sodium, injection cephalosporine Sodium, cephalosporine sodium for injection, potassium clavirate for injection, sodium omeprazole for injection, and so far Fosun Pharma has accumulated 53 acceptance numbers (32 varieties) to declare consistency evaluation, of which 17 varieties have passed the consistent evaluation.
Fosun Pharmaceutical Group consistency evaluation details table from the regional point of view, whether it is the acceptance number or the number of varieties, Jiangsu is worthy of the pharmaceutical province, 2020 consistency evaluation declaration acceptance is still leading, are ranked first.
region declaration acceptance number TOP10 region declared varieties TOP10 over-evaluation details 201 varieties over-evaluation of benzoate chloride flat tablet competition is the most intense, Qilu, stone medicine Ouyi, Zhengda Tianqing ... The big winner in 2020 in addition to the consistency evaluation declaration acceptance attracted attention, the review and approval of the evaluation is more eye-catching, the consistency evaluation entered the harvest period, in 2020 a total of 493 acceptance numbers (201 varieties) through the consistency evaluation year-on-year 279 acceptance numbers (116 varieties) increased by 76.70%.
From the variety point of view, of which 2020 benzodiamin chloride tablets are the most competitive, according to pharmaceutical data show that up to now, 38 enterprises have been evaluated the consistency evaluation of benzoate chloride tablets;
2020 varieties through the number of enterprises TOP10 so far varieties through the number of enterprises TOP10 it is also worth mentioning that in the second half of this year, especially in the last two months, there are continuous injections in accordance with the supplementary application through the consistent evaluation, so far a total of 24 injection supplement applications Through the consistent evaluation, there is no shortage of 1 billion to 10 billion yuan varieties, such as Yangzijiang's iodized kesal injection, Haussen Pharmaceuticals injection of gysytabin hydrochloric acid, Zhengda Tianqing injection of sodium pentoladium and so on.
more injection consistency evaluation details can be found in the schedule at the end of the article.
From an enterprise point of view, so far Qilu Pharmaceutical Co., Ltd. has been the biggest winner of the consistency evaluation, with 35 varieties passing/treating through consistency evaluation, of which 17 have been adopted in 2020; In 2020, 20 of them have been evaluated, and zhengda Tianqing, Yangzijiang, Koren Pharmaceuticals, Huahai and Howson Pharmaceuticals have now passed more than 20 consistent evaluations, half of which are 2020 varieties.
Up to now, enterprises through the consistent evaluation of varieties TOP10 2020 enterprises through the consistent evaluation of TOP10 from a national regional perspective, Jiangsu through the consistent evaluation of varieties far more than other provinces, up to now a total of 163 varieties over-evaluation, almost twice the second and third;
the region through the number of varieties TOP10 2020 region through the number of varieties TOP10 attached: injection consistent evaluation details table