Qilu big breakthrough! The first injection supplement application was reviewed by 41 product leaders.

On October 21st, CDE issued a notice on matters related to supplementary information for injection consistency evaluation, noting that some varieties of registered declaration data are obviously defective and need to be supplemented by a large number of new research work, if the written supplementary information is not submitted as required, or if the supplementary information is substantially defective, it will be handled according to non-approval, the news, the industry is very worried.
October 22, NMPA released the latest batch of drug approval information, two injections of consistent evaluation of supplementary applications were approved, no doubt for the industry a strong shot.
Figure 1: Latest approved injection products approved for conformity evaluation Source: NMPA website Up to now, there are 45 injectable products approved or treated as consistent evaluation, 3 products approved by supplementary application, including Hainan Puli approved in 2018 Pharmaceutical injection with Achimycin and newly approved Shenzhen Tiando Pharmaceutical Ino heparin sodium injection, Qilu pharmaceutical injection with Parexib sodium (Sichuan Huiyu Pharmaceutical injection with peme quarrydi sodium new classification registration and supplementary applications have been approved, not included in the analysis of this article).
Qilu Pharmaceutical's consistent evaluation results in the industry in a leading position, Milnet data show that up to now the company has reviewed or reviewed the number of products up to 41, of which according to the new classification registered approved and evaluated 25 products (including 3 injections: oxalibhin injection, injection with yew alcohol (albumin binding type), injection with bivalditin), consistent evaluation of the supplementary application approved products have 16 (including 1 injection: injection of paroxeb sodium).
Table 1: So far Qilu has reviewed the product situation Source: MED2.0 China Drug Review Database numerous over-evaluation product reserves, resulting in Qilu's excellent performance in the national harvest: the first batch of national collection (alliance) Expansion phase) winning 5 products: atovastatin calcium tablets, o nitrogen flat tablets, lipe ketone tablets, giffeitinib tablets, fumarate nofove diamide tablets; Standard 4 products Adelfowe ester tablets, amber acid Solina new tablets, hydrochloric acid qumentazepam slow release tablets, tiggio capsules; Mouth-breaking tablets,acid sidina tablets, capertabin tablets, Monrust sodium chewing tablets,acid tofatin tablets, Viglitin tablets, relying on kaoxi tablets.
Injection consistency evaluation work is in full swing, Qilu has now declared 26 injections of consistency evaluation supplementary applications, of which the injection of Parexib sodium has been evaluated, there are 25 products in the review and approval, we wait for the arrival of good news.
Table 2: Additional Applications for Injection Consistency Evaluation currently under review by Qilu Source: MED2.0 China Drug Review Database Source: NMPA Official Website, Minnet Database.