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Recently, news of the termination of the registration process of the new drug fasudil hydrochloride injection of Tonghua Guhong, a wholly-owned subsidiary of Buchang Pharmaceutical, came o.
Buchang Pharmaceutical announced on the evening of May 9 that due to the need to further improve the application materials for fasudil hydrochloride injection, after careful research and decision, Tonghua Guhong applied to the State Food and Drug Administration to withdraw the drug registration of fasudil hydrochloride injection app.
The data show that the main indications of fasudil hydrochloride injection are to improve and prevent postoperative cerebral vasospasm and cerebral ischemia symptoms after subarachnoid hemorrha.
Up to now, Tonghua Guhong has invested about 6487 million yuan in research and development expenses on fasudil hydrochloride injecti.
However, Buchang Pharmaceutical stated in the announcement that Tonghua Guhong's application for withdrawal of the registration application for fasudil hydrochloride injection will not have a significant impact on the company's current performan.
In fact, it is not uncommon for applicants to withdraw their drug registration applications voluntari.
In April, Biogen also announced that it had decided to withdraw the marketing authorization application for its Alzheimer's disease drug aducanumab in Europe, citing a lack of data to support .
On March 30, Aidi Pharmaceutical announced that the company decided to terminate the metformin hydrochloride sustained-release tablet (specification: 500mg) project after careful consideration in accordance with the relevant policies for the approval of generic drugs and the current situation of the research projec.
The company has submitted the "Drug Registration Withdrawal Application" to the State Food and Drug Administration to voluntarily apply for the withdrawal of the registration application of metformin hydrochloride sustained-release tablets (specification: 500mg), and recently received the State Food and Drug Administration's "Drug Registration Application Termination Notice", agreeing Terminate the registration proce.
As for the reason for the termination of the project, Aidi Pharmaceutical stated that the project has not yet obtained the approval for the marketing license since the project was launched, and there are still major uncertainties in the approval of the project according to the current status of the project, which is no longer in line with the company and the technology transfer.
Therefore, the company and the technology transferor have negotiated and decided to terminate the transfer and research and development of this proje.
For another example, on the evening of March 14, Kangchen Pharmaceutical issued an announceme.
On March 11, the company learned that Kangchen Bio, a holding subsidiary, received a notice from the State Food and Drug Administration on agreeing to withdraw the drug registration application for teriparatide injecti.
It is reported that due to the need to further improve the application materials, after careful research and decision, Kangchen Bio applied to the State Food and Drug Administration to withdraw the application for the clinical trial of teriparatide injecti.
Judging from the reasons for the withdrawal of applications by the above-mentioned pharmaceutical companies, it is mainly related to factors such as lack of data support, incomplete application materials, and major uncertainties in the approval of projec.
The industry said that drug clinical trial data is an important basis for determining the effectiveness and safety of dru.
Real, standardized and complete clinical trials are the source of guarantee for the safety and effectiveness of drugs, and verification of their data is a legal procedure before drug approval and marketi.
In the past, China's modern pharmaceutical industry started relatively late, and there was still a big gap between the quality of some drugs and the quality and efficacy of the original research produc.
In addition, the basis for drug research and development and the supervision of clinical trials were weak, and there was a lack of drug review capabiliti.
It is easy to fabricate and tamper with da.
, concealed data, untraceable original data, untrue experimental drugs,e.
In recent years, with the stricter supervision of the pharmaceutical industry, the importance of drug clinical trial data has become more and more promine.
Relevant departments and pharmaceutical companies have actively carried out self-inspection and verification of drug clinical trial data, and the level of clinical trial management and research and development has been continuously improv.
Buchang Pharmaceutical announced on the evening of May 9 that due to the need to further improve the application materials for fasudil hydrochloride injection, after careful research and decision, Tonghua Guhong applied to the State Food and Drug Administration to withdraw the drug registration of fasudil hydrochloride injection app.
The data show that the main indications of fasudil hydrochloride injection are to improve and prevent postoperative cerebral vasospasm and cerebral ischemia symptoms after subarachnoid hemorrha.
Up to now, Tonghua Guhong has invested about 6487 million yuan in research and development expenses on fasudil hydrochloride injecti.
However, Buchang Pharmaceutical stated in the announcement that Tonghua Guhong's application for withdrawal of the registration application for fasudil hydrochloride injection will not have a significant impact on the company's current performan.
In fact, it is not uncommon for applicants to withdraw their drug registration applications voluntari.
In April, Biogen also announced that it had decided to withdraw the marketing authorization application for its Alzheimer's disease drug aducanumab in Europe, citing a lack of data to support .
On March 30, Aidi Pharmaceutical announced that the company decided to terminate the metformin hydrochloride sustained-release tablet (specification: 500mg) project after careful consideration in accordance with the relevant policies for the approval of generic drugs and the current situation of the research projec.
The company has submitted the "Drug Registration Withdrawal Application" to the State Food and Drug Administration to voluntarily apply for the withdrawal of the registration application of metformin hydrochloride sustained-release tablets (specification: 500mg), and recently received the State Food and Drug Administration's "Drug Registration Application Termination Notice", agreeing Terminate the registration proce.
As for the reason for the termination of the project, Aidi Pharmaceutical stated that the project has not yet obtained the approval for the marketing license since the project was launched, and there are still major uncertainties in the approval of the project according to the current status of the project, which is no longer in line with the company and the technology transfer.
Therefore, the company and the technology transferor have negotiated and decided to terminate the transfer and research and development of this proje.
For another example, on the evening of March 14, Kangchen Pharmaceutical issued an announceme.
On March 11, the company learned that Kangchen Bio, a holding subsidiary, received a notice from the State Food and Drug Administration on agreeing to withdraw the drug registration application for teriparatide injecti.
It is reported that due to the need to further improve the application materials, after careful research and decision, Kangchen Bio applied to the State Food and Drug Administration to withdraw the application for the clinical trial of teriparatide injecti.
Judging from the reasons for the withdrawal of applications by the above-mentioned pharmaceutical companies, it is mainly related to factors such as lack of data support, incomplete application materials, and major uncertainties in the approval of projec.
The industry said that drug clinical trial data is an important basis for determining the effectiveness and safety of dru.
Real, standardized and complete clinical trials are the source of guarantee for the safety and effectiveness of drugs, and verification of their data is a legal procedure before drug approval and marketi.
In the past, China's modern pharmaceutical industry started relatively late, and there was still a big gap between the quality of some drugs and the quality and efficacy of the original research produc.
In addition, the basis for drug research and development and the supervision of clinical trials were weak, and there was a lack of drug review capabiliti.
It is easy to fabricate and tamper with da.
, concealed data, untraceable original data, untrue experimental drugs,e.
In recent years, with the stricter supervision of the pharmaceutical industry, the importance of drug clinical trial data has become more and more promine.
Relevant departments and pharmaceutical companies have actively carried out self-inspection and verification of drug clinical trial data, and the level of clinical trial management and research and development has been continuously improv.
