On June 30, the CFDA issued a review of its clinical trial data for the first time in 2017. The announcement, a total of 106 companies, 135 drug registration application has been withdrawn, and withdraw the drug list is no longer only the first clinical trial data comprehensive verification announcement no. 117 (2015), and from "about drug clinical trial data check list check the announcement of registration of 2016 (no. 81, no. 142, no. 171, no. 202 and no. 42, 2017).
In terms of the withdrawal rate, the 2033 acceptance Numbers were withdrawn in total of 1,327, and the overall withdrawal rate was as high as 65 percent. Among them, the first batch of clinical trial data self-inspection and verification announcement (no. 117 in 2015) had the highest withdrawal rate, which was 75%. The second is the second batch of clinical trial data self-verification notice (no. 142 of 2016), once again the fifth batch of clinical trial data self-inspection notice (no. 81 of 2016), and the withdrawal rate is over 30%.
Table 1: clinical trial data to verify the overall withdrawal of the data
(data source: Brenda data V3.2)
Self-check withdrawal: the more you declare, the more you withdraw?
To withdraw from the enterprise quantity, shiyao group (shiyao group the meaning pharmaceutical co., LTD., nolato, in pharmaceutical technology (shijiazhuang) co., LTD., nolato, group of novartis pharmaceutical (shijiazhuang) co., LTD and shiyao group grace will pharmaceutical co., LTD.) to withdraw his largest withdrew 25 31 to accept order. Followed by huahai and hengrui (jiangsu hengrui pharmaceutical co., LTD., chengdu hengrui pharmaceutical co., LTD. And Shanghai hengrui pharmaceutical co., LTD.), huahai 21 accepted number 17, withdrew withdrew 17 hengrui 23 to accept order. Zhengda sunny system (zhengda pharmaceutical group co., LTD., nanjing zhengda sunny the weather is fine pharmaceutical co., LTD., jiangsu zhengda sunny pharmaceutical co., LTD.) withdrew 15 28 to accept order, follow.
The international management experience of generic drugs in us listed by shiyao group, huahai and hengrui is also so high that other domestic enterprises can imagine the quality of their projects.
However, more enterprise's executive ability and resilience is also very strong, hengrui on June 30, to declare the once withdraw for injection for mo thiazole amine, shiyao group temporarily undeclared after the withdrawal of products listed, but in 2017 consecutive called the metformin hydrochloride, metformin hydrochloride zyban, for Greg lowe, clopidogrel bisulfate pieces and for sand for pieces and big market potential products listed.
In terms of products, the benzene sulfonate amlodipine tablet is the product that enters the clinical trial data self-examination verification list to accept the largest number of products, and also the most withdrawn products. A total of 18 clinical trials were accepted by rishuvastatin calcium tablets in the clinical trial data, second only to benzensulfonate chloride tablets, and the withdrawal rate was also 56%.
Salty V3.2 further analysis of data of benzene sulfonic acid amlodipine piece found that CYHS1190047, CYHS1190074, CYHS1190107 and CYHS1290027 four accepted number is system certificate in 2015, the state administration of withdraw not released related to accept order, is expected to list belong to actively withdrawn the product. CYHR0900256 is a review and is currently in "review and approval" status, after the company's reported production was not approved. Thus, benzene sulfonic acid amlodipine piece in 23 introspection to accept order, in addition to friends and chongqing medicine pharmaceutical co., LTD. (CYHS1390088) to the scene of the drug clinical trial data verification plan announcement (7) basic completely annihilated. The only person on the withdrawal list is the company of fupke pharmaceutical (wuhan) co., LTD. In May 2017.
Table 2: check and verify the number of products in the top 10
Data source: salty da data V3.2
A total of 495 products all the clinical trial data inspection check list to accept the number of withdraw entirely, including filing acceptance number more than five full withdrawal of products for gonow capsule, piece left b raschig, recombinant human granulocyte stimulating factor injection, propofol injection, of the mooring dean alpha injection, mifepristone tablets, cefixime capsule, cefixime granules and hydrochloric acid than naphthalene Finn.
Filing acceptance number more than 5, and no one notice to withdraw and shall not be approved product drug lenalidomide capsule, kang fu ling tablet and smilax China dispersible tablets, reed phosphate can for sodium, sand kubah valsartan pills, injection with human recombinant coagulation factor Ⅷ, Glenn net metformin hydrochloride and methoxyl polyethylene glycol restructuring to promote red injection, Leo west gung slices and hydrochloric acid for it.
On-site verification: the list of dead and dead born?
Since March 30, 2016, the CFDA food and drug audit inspection center regularly released drug clinical trial data field verification plan, as of July 13, 2017, has published 12 # 351 to accept the batch directory, notice the on-site verification withdraw products a total of 40, after withdrawal rate was 11%.
Withdraw after acceptance into the inspection number of most enterprises is novartis, Beijing novartis pharma co., LTD., withdrew lactic acid puppy he capsules 3 accept order, Shanghai novartis trading co., LTD., withdrew the clopidogrel bisulfate tablet and diazepam tora azole sodium enteric-coated metformin hydrochloride each 1 to accept the number.
Pharmaceutical group co., LTD., Shanghai zhengda shine citic countries health pharmaceutical co., LTD., bristol-myers squibb (China) investment co., ltd. and hunan warner has two big pharma co., LTD. Each accepts the number to withdraw. Zhengda tianqing pharmaceutical group co., LTD. Has withdrawn its sodium hydrochloride injection and injection of polymyxin E methylsulfonate. Shanghai citic Pacific pharmaceutical co., LTD. Has withdrawn its recombinant anti-cd20 mouse chimeric monoclonal antibody injection and injection recombinant anti-her2 humanized monoclonal antibody. Bristol-myers squibb (China) investment co., LTD. Hunan warner big pharmaceutical co., LTD. Has withdrawn the left ornidazole dispersion tablet and the left ornidazole capsule.
It is worth noting that bristol-myers squibb (China) investment co., LTD. O withdraw by ShuRuiWei soft capsule and dara he wei hydrochloride in the administration approval dara he wei hydrochloride and ShuRuiWei o soft capsule "announced in the listing. According to the V3.2 data, the two admissible Numbers JXHS1600062 and JXHS1600068 were reported in the da-hla tablet, among which JXHS1600062 was withdrawn in this notice, and the corresponding clinical trial body was Peking University people's hospital. JXHS1600068 did not enter the clinical self-inspection verification and the on-site assessment list was approved. According to CFDA's official website, there are 2 listed batch Numbers (H20170242 and H20170322), which are available in 60mg.
O ShuRuiWei soft capsule is also similar, JXHS1600063 and JXHS1600067 production, in clinical inspection check JXHS1600063 withdrew, and the assessment of the scene to accept order, accept order JXHS1600067 approved listing a batch number (H20170241), specification of 100 mg. The clinical trial organization is also Peking University people's hospital.
Table 3: the overall withdrawal of the on-site verification plan
(data source: Brenda data V3.2)
Conclusion the < < <
Clinical trial data check list for verification to make a big Bob suspicious drug delayed the project quality, clinical data, but on the other hand it could protect project quality may not conform to the requirements of the existing laws and regulations of drugs already on the market.
The 65% withdrawal rate means that the unstandard waste of resources in the past is a huge waste, as well as the over-heating of China's past generics.
Data from withdrawing, generics companies can learn is through quality improvement to win competition way never stop, policy limit should not be required by the enterprise pursues the lower limit of project quality. |
