Since July 22, 2015, the medical website has released seven batches, and 2033 of them have entered clinical self-examination checklist. Of the seven inspections, there were 387 imported drugs. In the Chinese provinces, jiangsu, Beijing, shandong, guangdong and zhejiang each have the top five, with more than 100. 

 

Priority review system since 2016, as of May 21, 2017, salty data V3.2 found, for a total of 212 to accept order priority review, 91 of which have entered clinical inspection check, than the visible accounted for 43% of the strength of the acceleration of the review. 2016 clinical inspection checklist on acceptance, 14% are from priority review, this share had risen to 34% in 2017, and thus the first check list after a few batch of their products, more to do with the innovation, the project of clinical needs. 

 

The number of the number of the number is accepted in 7 batches 

 

(source: saldar data V3.2) 

 

Domestic self-examination is based on generics: shi yao and tianqing are the most numerous enterprises that have the largest number of products 

 

The announcement was basically the first batch of clinical self-examination checklist to be released. In the second to seven batches of clinical self-examination checklist products, the group of shiyao group and cp tianqing reported the first number of products. The products of the two are mainly generic drugs, especially the first imitative or double medicine. 

 

Shiyao group how to declare Pan Li plate, metformin hydrochloride and moxifloxacin hydrochloride tablet and injection of paclitaxel (albumin combined type), hydrochloric acid by nida and Iraq Pan Li ketone pills, currently only nida, "RON hydrochloride in drug clinical trial data on-site verification plan announcement (5). 

 

Dimetformin, a stone, was approved in the United States. CFDA May 18 in 2017 finally released a generic quality and curative effect evaluation and guiding principles for developing the inspection consistency four guiding principles of circular no. 77 (2017), including the quality of generic drugs and curative effect evaluation of consistency "guiding principles" study the inspection "production site inspection guidelines" "guidelines" clinical trial data verification and "evaluation" guidelines for inspection, this means that the United States and the double quote products is expected to speed up the approval, shiyao of metformin hydrochloride is expected to be listed in 2017 years. 

 

Zhengda shine with fumaric acid to declare tenofovir two pyrazole cefuroxime ester, drug lenalidomide capsule, hydrochloric acid, ROM for capsule, injection with double meglumine FuSha horse, vial ZuoPan tora azole sodium statin calcium tablet and comfortable. 

 

Domestic manufacturers self-report also make a heap: ammonia chlorine is flat heat not reduce 

 

Domestic manufacturers are also in the second to seventh batch of clinical self-examination checklist products. Benzene sulfonic acid amlodipine piece of domestic manufacturer production approval number up to 65, but it is still the domestic manufacturers to declare one of the most popular products, a total of 4 companies declare, friends are chongqing medicine pharmaceutical co., LTD., jiuquan big benefit pharmaceutical co., LTD., Beijing is forever pharmaceutical co., ltd. and hebei dongfeng pharmaceutical co., LTD. Currently, only chongqing pharmaceutical company pharmaceutical co., LTD. Is on the list of medical test data for clinical trial data. It is reported that the chongqing drug friends project is declared according to the quality standard of the conformity assessment. 

 

Followed by fumaric acid tenofovir two pyrazole cefuroxime ester, zhengda pharmaceutical group co., LTD. The weather is fine, qilu pharmaceutical co., LTD. And anhui baker biological pharmaceutical co., LTD., is still waiting for a second opportunity to domestic manufacturer listed, all three at the scene of the drug clinical trial data verification plan announcement, press is supposed to have the result of examination and approval in 2017. 2016 times, chengdu pharmaceutical co., LTD., listed the variety, the approved indications for HIV - 1 infection, fumaric acid tenofovir two pyrazole cefuroxime ester is suitable for the combination with other antiretroviral drug treatment of adults infected with HIV - 1. 

 

However, administration of protection of innovators about medical equipment innovation encourage drugs policy (draft) mentioned that "success and overseas listed but domestic first challenge patent drugs in imitation of a listed for 1.5 years data protection, data protection during the term of the review agency no longer approve the other applicants with varieties listed application, except for the applicant to obtain data". Chengdu bate pharmaceutical co., LTD. The first time to market is in November 2016, fumaric acid tenofovir two pyrazole whether cefuroxime ester slice of a second to postpone to June 2018, remains to be seen. 

 

2017 years wide hall fumaric acid tenofovir two pyrazole cefuroxime ester capsules, visible from CDE clinical trials, wide raw hall indications for treatment of adult patients with chronic hepatitis b. Fujian Cosunter Pharmaceutical Co., Ltd., a total of 2 accept order into the first clinical comprehensive verification, old chemical medicine category 5 classes declare CXHS1300370 in announcement no. 264 in 2015 to withdraw, old chemical medicine classification 3.1 class CXHS1400157 would not have to declare to withdraw and get priority review. At present, the fumaric acid tenofofuroful capsule is reported in chengdu double t pharmaceutical co., LTD. 

 

Moxifloxacin hydrochloride is also a hot spot, PKU HealthCare Corp., Ltd., nolato, group the meaning pharmaceutical co., Ltd and nanjing xingang pharmaceutical co., Ltd in clinical inspection check list, but there is no one in drug clinical trial data on-site verification plan announcement. 

 

The import of imported drugs is fast and new: novo kubara, the valsalam sodium tablet (LCZ696), is about to be approved 

 

Since the administration on March 17, 2017, is seeking "imported drug registration management related matters about adjusting decision (draft)" has been, imports of good news. In the seventh batch, 35 of the 44 accepted Numbers were from imported products. Seventh batch check list for priority review qualification of seven product number 19 to accept only ernesto hydrochloride for capsules are domestic manufacturers zhengda pharmaceutical group co., LTD. The weather is fine, the rest are all imported products. 

 

Seven priority review products, boehringer ingelheim (China) investment co., LTD. Consult Joe bromide Mr Dutt, spray inhalation and injection of bayer healthcare use human recombinant coagulation factor Ⅷ declare is clinical, the rest is listed on the declaration, which means the five products is expected to be approved in 2017. 

 

Zhengda ernesto hydrochloride for the weather is fine, the capsule is completed clinical indications have more than three lines and advanced non-small cell lung cancer, in the late research indications have medullary thyroid carcinoma, advanced soft tissue sarcoma, colorectal cancer, advanced renal cell carcinoma, the integration of a terminal cancer of the stomach, the stomach esophagus adenocarcinoma and esophageal squamous cell carcinomas. Audarrow inhaled aerosols for chronic obstructive pulmonary disease (COPD). Delamani tablet is a treatment for mdr-tb. The treatment of an adult patient with severe depression (MDD) was found in the noritic antidepressant hydrobromide tablet. Novartis's sand kubah qu valsartan sodium tablets (LCZ696) clinical trials completed evaluation LCZ696 for primary hypertension after 8 weeks of treatment efficacy and safety, and reduce the morbidity of chronic heart failure and mortality study, is expected to indications for chronic heart failure. 

 

Table 2, the seventh batch of review products 

 

(source: saldar data V3.2) 

 

Focal point 

 

Import drugs have been sped up, and can domestic drug approvals be sped up? 

 

In general, in clinical inspection checklist, entering the clinical trial data on-site verification plan announcement before entering the drug approval process, the second batch of self checking list to the seventh batch of inspection list of domestic manufacturers to accept the number 195, only 12 priority review, entering the clinical trial data on-site verification plan announcement 25; In comparison, the number of imported products was accepted by 216, and 63 were given priority, and 96 were reported to the clinical trial data site verification plan. 

 

Priority review to compare the clinical demand and innovation, our main generic drug is given priority to, to declare the number of priority review domestic drug is low. However, from the progress of the investigation of the clinical trial data, the approval of the domestic products is lower than that of the imported products. 

 

A lot of imported drugs companies complained that the 2017 adverse drug administration expired drugs, is the original date medicine hospital market in printing.if lost sign, 2017 new drugs approved or import license of temporarily imported drugs product line fraught with difficulties. 

 

Domestic manufacturers face the same dilemma. Unfortunately, many manufacturers do not have the right to meet the new rules. The first batch of generic drugs, which have been unlisted and confident about the quality of the project, have been waiting for faster approval, two years since 2015. "Go", or "stay", need a hammer.