The clinical research of the new drug is approved.
Release time: 2011-03-25 & nbsp & nbsp & nbsp Source:
Business Club, March 22. There has always been a saying that it has been widely developed in foreign countries，Doing clinical research in China is strictly advanced。In fact, this situation has long changed。In China，Many new drugs that get clinical approval，Can't pass the last listing approval。From the personal experience of personal，Compared with clinical research in North America，In many aspects，China's requirements are much higher。Let's roughly talk about the following aspects。
Report on serious bad events
On the report of severe adverse events (SAE)，China's requirements are much stricter than other countries。According stake betting appto the Stake Sports Betting"Administrative Measures for the Registration of Drug Registration" according to the bureau: SAE during clinical trials，Researchers shall report about the province within 24 hours、Autonomous Region、Drug Supervision and Administration Department of Municipality and State Food and Drug Administration，Notification applicant，Report to the Ethics Committee in time。
So，Researchers after discovering SAE，Need to report 3 units: drug supervision bureau or subordinate institution、Applicants and Ethics Committee。At the same time，Report on the drug supervision bureau and applicant，It needs to be completed within 24 hours。
I discussed this question with colleagues abroad。They look at China's level of clinical research。Everyone agrees，This is the protection of the rights and interests of the subject，The United States and Canada should also be aligned with this standard。
In North America and the European Union,，The report on serious adverse events is operated by referring to the standard of ICH E2。Susar (suspicious related、Non -expected serious adverse incidents) need to report the drug management department by the applicant within 15 days，Death or threatening life，The applicant reports to the drug management department within 7 days。General SAE，No requirements are made in the report time。
In the serious adverse events reported abroad，Susar occupies a small proportion，and not report My stake betting appit within 24 hours，Researchers stake betting appdo not need to directly report to the drug management department，Researchers have reported it to the applicant，Then report it to the Ethics Committee。
Under normal circumstances，The SOP of the applicant requires the researchers to report the SAE report found to the applicant within 24 hours。The drug supervision department of the applicant investigates the SAE，When necessary, researchers are required to supplement information。If the person in charge of the drug supervision department of the applicant，Ru Medical Director，Think that this serious adverse event is Susar，So，within 15 working days，Report SUSAR to the drug management department。This is the origin of the 24 -hour report。China is directly in place。If all SAEs are reported，The workload of the Drug Administration can be imagined。
SOP from the test agency
In North America，The selection of the researcher is completely determined by the applicant。The applicant has a certain standard for the selection of researchers。In China，The certification indicators of the research institution are much more complicated。For example，Drug Administration requires the design specifications of the clinical research base for clinical research bases、Specifications for reporting forms for cases、Design specifications of informed consent form。Just these a few，Pilot institutions in the United States and Canada cannot pass percent of them，Researchers Stake Sports Bettingthemselves Stake Sports Bettingare clinicians，How can they design a new drug clinical research plan and case report form?
At the same time，Audit from Chinese clinical research institutions，You need to provide various SOP。In North America，Many very experienced experimental agencies，There is no perfect SOP。Because of SOP，You must follow the execution。Once there are some details, do not follow the execution，During the inspection, I was found，It is a bad record。
Relatively speaking，Many aspects of clinical research，There are no hard regulations in North America，However, once it is formed,，Including regulations、SOP, etc.，All need to be executed。
Chinese clinical research institutions from the certification standards，much higher than North America。Base is capable design scheme、CRF and Knowledge Consent，With SOP，and have a certain data management function。These are all the test bases in North America。
Flight examination (on -site inspection)
FDA and Canada's pharmaceutical supervision departments often conduct audit on trial bases in North America (INSPECTION)。Generally, the test base is notified from the FDA 2 to 3 months in advance，Then immediately notify CRO and Pharmaceutical Factory。CRO's CRA needs to fully prepare the data of the test base immediately。Under normal circumstances，CRO's project manager and the medical director of the pharmaceutical factory must be with CRA，Check in the base for details，Basically found that there is no typo。
stake betting appChinese flight inspection generally My stake betting appnotified in advance for about one week。Researchers and CRO can prepare very limited time，This can better reflect the real situation of clinical research。
From the perspective of the details of the inspection，SFDA also deepen。For example，I heard that some inspectors call the patient directly，It is confirmed that patients have participated in this clinical study。It is not allowed in North America，Because doing this may involve the privacy of the patient。(Author: Li Bin)
Report on serious bad events
On the report of severe adverse events (SAE)，China's requirements are much stricter than other countries。According stake betting appto the Stake Sports Betting"Administrative Measures for the Registration of Drug Registration" according to the bureau: SAE during clinical trials，Researchers shall report about the province within 24 hours、Autonomous Region、Drug Supervision and Administration Department of Municipality and State Food and Drug Administration，Notification applicant，Report to the Ethics Committee in time。
So，Researchers after discovering SAE，Need to report 3 units: drug supervision bureau or subordinate institution、Applicants and Ethics Committee。At the same time，Report on the drug supervision bureau and applicant，It needs to be completed within 24 hours。
I discussed this question with colleagues abroad。They look at China's level of clinical research。Everyone agrees，This is the protection of the rights and interests of the subject，The United States and Canada should also be aligned with this standard。
In North America and the European Union,，The report on serious adverse events is operated by referring to the standard of ICH E2。Susar (suspicious related、Non -expected serious adverse incidents) need to report the drug management department by the applicant within 15 days，Death or threatening life，The applicant reports to the drug management department within 7 days。General SAE，No requirements are made in the report time。
In the serious adverse events reported abroad，Susar occupies a small proportion，and not report My stake betting appit within 24 hours，Researchers stake betting appdo not need to directly report to the drug management department，Researchers have reported it to the applicant，Then report it to the Ethics Committee。
Under normal circumstances，The SOP of the applicant requires the researchers to report the SAE report found to the applicant within 24 hours。The drug supervision department of the applicant investigates the SAE，When necessary, researchers are required to supplement information。If the person in charge of the drug supervision department of the applicant，Ru Medical Director，Think that this serious adverse event is Susar，So，within 15 working days，Report SUSAR to the drug management department。This is the origin of the 24 -hour report。China is directly in place。If all SAEs are reported，The workload of the Drug Administration can be imagined。
SOP from the test agency
In North America，The selection of the researcher is completely determined by the applicant。The applicant has a certain standard for the selection of researchers。In China，The certification indicators of the research institution are much more complicated。For example，Drug Administration requires the design specifications of the clinical research base for clinical research bases、Specifications for reporting forms for cases、Design specifications of informed consent form。Just these a few，Pilot institutions in the United States and Canada cannot pass percent of them，Researchers Stake Sports Bettingthemselves Stake Sports Bettingare clinicians，How can they design a new drug clinical research plan and case report form?
At the same time，Audit from Chinese clinical research institutions，You need to provide various SOP。In North America，Many very experienced experimental agencies，There is no perfect SOP。Because of SOP，You must follow the execution。Once there are some details, do not follow the execution，During the inspection, I was found，It is a bad record。
Relatively speaking，Many aspects of clinical research，There are no hard regulations in North America，However, once it is formed,，Including regulations、SOP, etc.，All need to be executed。
Chinese clinical research institutions from the certification standards，much higher than North America。Base is capable design scheme、CRF and Knowledge Consent，With SOP，and have a certain data management function。These are all the test bases in North America。
Flight examination (on -site inspection)
FDA and Canada's pharmaceutical supervision departments often conduct audit on trial bases in North America (INSPECTION)。Generally, the test base is notified from the FDA 2 to 3 months in advance，Then immediately notify CRO and Pharmaceutical Factory。CRO's CRA needs to fully prepare the data of the test base immediately。Under normal circumstances，CRO's project manager and the medical director of the pharmaceutical factory must be with CRA，Check in the base for details，Basically found that there is no typo。
stake betting appChinese flight inspection generally My stake betting appnotified in advance for about one week。Researchers and CRO can prepare very limited time，This can better reflect the real situation of clinical research。
From the perspective of the details of the inspection，SFDA also deepen。For example，I heard that some inspectors call the patient directly，It is confirmed that patients have participated in this clinical study。It is not allowed in North America，Because doing this may involve the privacy of the patient。(Author: Li Bin)
